Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
CSMG News is listed on Google Finance
FYI Market Sell Order for 100 shares filled at .15
Hope is on the Horizon... Dr. Patrick Lee and Cancer Stem Cells
http://dalnews.dal.ca/2009/06/23/cancer.html
Article dated June 23, 2009 from Dalhousie the Dalhouse University alumni magazine.
By Melanie Jollymore
Hope has enormous significance for anyone who has experienced a cancer diagnosis.
Emmie Luther-Hiltz was just 33 years old when she woke up one Easter Sunday to find a golf-ball-sized lump in her breast – a lump that had not been there the day before.
Emmie Luther-Hiltz: "This kind of news means that maybe our children won’t have to live with such an overwhelming fear of developing cancer. Hope is on the horizon." (Danny Abriel Photo)
“It was an aggressive cancer with a very tough prognosis,” says Ms. Luther-Hiltz, whose two children were just five and eight years old at the time. After having her breast and grossly malignant lymph nodes removed, she endured six months of chemotherapy.
Remarkably, she is alive and well 16 years later, but that doesn’t mean her fear of cancer has gone away. “Breast cancer can recur after 15, even 20 years,” she says. “I’ve had a number of scares and, just last year, had my other breast removed when we found a benign lump.”
As a cancer survivor who works closely with patients through Cancer Care Nova Scotia, Ms. Luther-Hiltz is heartened by the recent news that Dalhousie virologist Patrick Lee has found a way to kill the very cells that lead to cancer recurrence. These are the cancer stem cells. Like a queen ant churning out eggs, cancer stem cells continuously produce new cancer cells.
“You can kill all the ants in the anthill, but if you don’t get the queen, you will still have ants,” says Dr. Lee, Cameron Chair in Basic Cancer Research at the Dalhousie Medical School. “Unfortunately, chemotherapy and radiation do not eliminate the cancer stem cells and they keep on producing cancer cells.”
Dr. Lee’s landmark finding – that a common virus effectively targets and kills breast cancer stem cells – recently appeared in the prestigious journal, Molecular Therapy. When the story broke, it led local newscasts, spread like wildfire online, and sparked a buzz of excitement in the cancer community.
“This is a fabulous discovery,” says Emmie Luther-Hiltz. “What it means is hope. Hope has
enormous significance for anyone who has experienced a cancer diagnosis.”
Dr. Lee is thrilled by his team’s findings, as he has been on a mission for the past two years to prove that human reovirus can kill cancer stem cells. Unlike most cancer experiments, which rely on cancer cell lines developed for the laboratory, Dr. Lee’s experiments used fresh tumour tissue from local breast cancer patients.
“Cell lines are grown in vitro so long, it’s hard to be certain your experiment is reflecting real life,” says Dr. Lee. “It’s very exciting to see these results in real biopsy material.”
He credits his collaborator, Dr. Carman Giacomantonio, a Capital Health surgeon and associate professor in Dalhousie’s Division of Surgical Oncology, for his dedication to the project. “Carman would bring us the breast tumour tissues within an hour or two of removing them from a patient.”
Whenever tumour tissues arrived in the lab, postdoctoral fellow Paola Marcato and research assistant Cheryl Dean worked late into the night, implanting tiny pieces of tumour in the mammary fat pads of mice while the grafts were still fresh enough to take hold and form tumours.
After injecting reovirus into the tumours, the researchers noted how quickly the cancer stem cells were dying compared to the regular cancer cells. “The cancer stem cells died at the same rate as the regular cancer cells,” says Dr. Lee. “This is exactly what we had hoped to see.”
Dalhouse University virologist Patrick Lee: "It’s very exciting to see these results in real biopsy material." (Danny Abriel Photo)
The media spotlight is nothing new for Dr. Lee. In 1998, he galvanized the world scientific community with his first groundbreaking discovery – that reovirus selectively targets and kills cancer cells without harming healthy cells.
“But proving we can target cancer stem cells is even more exciting than the original discovery,” he says. “It means we finally have a way to get to the root of the problem.”
Reovirus kills cancers of the lung, prostate, colon, ovary and brain, as well as lymphoma and melanoma, as shown by Dr. Lee’s previous studies. “We have every reason to believe that reovirus will kill the cancer stem cells in these and other kinds of cancer,” he says. “We plan to test it against prostate cancer stem cells next.”
As the researchers explore additional potential in their lab, a Calgary-based company, Oncolytics Biotech, is testing the virus in cancer patients.
“We have had dramatic results in both phase one and phase two clinical trials in a wide range of cancers, including sarcomas, ovarian, pancreatic and advanced head and neck cancers,” says Matt Coffey, the company’s chief operating officer. “Now we’re getting ready to launch international phase three clinical trials.”
The pair began working together at the University of Calgary on the original reovirus discovery. Oncolytics Biotech was launched to develop and test reovirus-based cancer therapies.
“Getting the cancer stem cells is key,” says Dr. Coffey. “We’re not here to delay cancer, we’re here to cure it.”
The worst side effects in cancer patients have been mild, flu-like symptoms, he notes. “The virus causes no disease, which makes it safe for patients and easy to work with.”
Meanwhile, Dr. Lee and his team are learning more about the cancer-killing advantages of reovirus every day.
“We think of cancer cells being so tough, but they are weak in the face of the virus,” says Dr. Lee. “Cancer cells are not capable of mounting a defense against the reovirus. They actually help the virus reproduce and form new virus particles that are many times more infectious than the parent virus!”
These virulent particles then rupture the cancer cell and circulate around the body, killing not just the primary tumour, but also cancer cells that have spread. At the same time, they stimulate a powerful anti-cancer immune response.
Dr. Lee and postdoctoral fellow Shashi Gujar are working on a way to maximize this anti-cancer response, while minimizing the immune system’s reaction to the reovirus. “We want to tone down the anti-virus response so reovirus can freely infect and kill cancer cells while helping the body mount its own anti-cancer attack,” notes Dr. Lee.
Drs. Marcato and Gujar are among the many young cancer researchers who have flocked to Dalhousie since Dr. Lee joined the medical school in 2003. Senior researchers have also come to work in the university’s increasingly dynamic cancer research community, which has grown from a handful of scientists to more than 50 principal investigators.
This growth spurt began with a remarkable gift to the Dalhousie Medical Research Foundation. In 1999, the late Beatrice Hunter bequeathed $12.5 million to the foundation for cancer research, in memory of her parents, Dr. Owen and Mrs. Pearle Cameron. This gift provides $500,000 to cancer research at Dalhousie Medical School each year. It also created the Cameron Chair in Basic Cancer Research, the leadership position that attracted Dr. Lee to Dalhousie.
Dr. Lee is a founding member of the Beatrice Hunter Cancer Research Institute, established in April 2009 to foster a coordinated cancer research effort in Atlantic Canada.
“Patrick Lee has helped create an environment where world-class cancer research can thrive,” says Theresa Marie Underhill, chief operating officer of Cancer Care Nova Scotia, which co-funds his cancer stem cell research with the Canadian Breast Cancer Foundation–Atlantic Region. “It’s rare for us, as the provincial cancer agency, to fund basic research, but Dr. Lee’s reovirus work is very close to patients, and even involved cancer patients going through surgery, so it was the right fit.”
“For an organization dedicated to a future without breast cancer, research is the most significant part of our work,” says Nancy Margeson, CEO, Canadian Breast Cancer Foundation–Atlantic Region. “To have a breakthrough of this magnitude substantiates our faith that one day our vision will come true.”
The Canadian Institutes of Health Research, the Canadian Cancer Society and the Terry Fox Foundation are also staunch supporters of Dr. Lee’s research. As he notes, every grant and every discovery builds on the one before, leading to those eureka moments that change everything.
For Emmie Luther-Hiltz, whose parents, grandparents, aunts, uncles and siblings have all battled cancer, Patrick Lee’s discoveries offer hope for the future. “Cancer is a way of life in our family,” she says. “This kind of news means that maybe our children won’t have to live with such an overwhelming fear of developing cancer. Hope is on the horizon.”
Feb16 conf call transcript H&N Phase III UK Approval
Thanks again to RJC for the great transcribing work
Topics addressed in the Q&A session include:
- Adaptive Design, and Related Penalties:
- How Adaptive Design got into the SPA:
- Enrollment Rate:
- Start of Enrollment:
- US/UK requirements:
- UK start-up:
- Site Distribution:
- Belgium:
- Patient Distribution:
- Total number of Sites:
- NSCLC:
- Trial Cost:
- Partnering:
- Uniform Enrollment:
- Next Presentations:
- And in summary …
Full transcript of the Q&A session from Oncolytics' Feb 16, 2010 UK Phase III H&N Approval conference call. The audio is currently available at: http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2967140
Q&A session, following a brief Phase III Clinical Program Update:
Adaptive Design, and Related Penalties:
{6:13} Miguel Nakamovitz(spelling?) [Rodman and Renshaw]: Could you discus a little bit more the details of this Trial in terms of the adaptive process … why this design was chosen, and perhaps if you could talk a bit about if there are any statistical penalties for examining the data after a certain number of patients have been enrolled?
Brad Thompson [Oncolytics Biotech]: The adaptive clinical designs have a very specific use and utility, and that is in indications where there is a fairly firm linkage between absolute response (like partial responses, stable disease, complete responses, time to progression), and overall survival. In indications where you don't have that tight linkage, I think you would not use an adaptive design. What an adaptive design does, is allows you to use that linkage (and we're relying primarily on time to progression linkage with overall survival), to predict from early data the statistical likelihood that you're going to succeed in the study, or have already reached an end point. So what it does, is it allows us to (in this case) enroll in a Phase IIIa / Phase IIIb structure. We'll enroll the first 80 patients, which will be split evenly between the control group (which is Carbo/Tax of 40 patients), and the test group which is Reolysin + Carbo/Tax at 40 patients . And then on the day that you enroll the 80th patient, you take a look at the time to progression data that you have at that time, for progression free survival, and that would be for all of them obviously on the 80th patient –you don't have any data, on patient 75, you have very short term data. If you actually do a statistical analysis about the probability of success, based on the fact that you have better time to progression data than you do with raw survival data at that point.
That gives you 3 outcomes at that point. One is that you stop the study because you actually believe you're at the end point … like you will reach statistical significance. The second is that you stop the study because there's absolutely no evidence that there's anything going on, and the third being that there is evidence of something going on but that you haven't reached statistical significance at 80 patients. And that's what our estimation is of the most likely outcome … that third one.
The adaptive design allows you to do that kind of statistical analysis which allows you to immediately verify, and proceed into the second stage of the study. The advantage of the second stage of the study is that it gives you a fixed end point; not being a fixed survival benefit, but a fixed statistical probability, so you're aiming for a p of .05 rather than a lifespan extension of say, of 16 weeks. So the number of patients that you enroll can vary to get to that p, so it ranges from 100 to 400 patients in the second stage of the study with the most statistically likely being 200. What that allows you to do is not basically exceed your end point when you've already reached the end point, and keep enrolling patients in a clinical study where they have a 50% chance of not getting the new triplet [Reo/Carbo/Tax], and so, say at 200 patients, you have statistical significance, then you're done, and you can stop the study then, as appose to carrying on and enroll another 200 patients, half of which won't get this hopefully better standard of care.
So I think it's a much more patient friendly study. It gets you to end points (good or bad), quicker. With respect to statistical penalties, of course in the first 80 patients there is no penalty, because you're looking at it after the 80 patients, and what we're planning on doing is: we'll treat the Phase IIIa data independently, the Phase IIIb data independently, and then there's the data merge, where you merge the data from both groups. We have actually three different looks at the data from the merger. There's an infinitesimal statistical penalty in the second stage, because what you're looking at is time to progression data, not the overall survival data as the end points. Actually your statistical penalty is not your primary end point; it's on your secondary end point. So your primary end point, which is overall survival, actually doesn't have really any penalty at all associated with it. So it's quite a powerful statistical tool, but the key thing is selecting where you use it, and I think that's where people have to be very cautious about the use of adaptive design. If you have an alternate earlier read … some indicator, some measure that is very tightly linked to the real outcome, that in this case being time to progression being linked to overall survival apparently, then you can use this kind of adaptive design. If you don't have that tight linkage, say with some of the other types of cancers, like say non-small lung which has a long tail of survivors already, on not as much of a tight link as between the time to progression and death, then I think that you should probably stick with a traditional statistical package.
How Adaptive Design got into the SPA:
{11:15} Miguel Nakamovitz: That was a good answer. Is this something that you proposed to the Agency, or did they suggest it, or was it more of a collaboration to come up with this design.
Brad Thompson: Well they've been actually very interested in adaptive design for quite some time and the Agency has been … candidly … the FDA gets criticized for not wanting to get things through quicker, but they're really just interested in us sticking to "the gold standard", which is overall survival, and that's really what we're looking at, but they're also being very aggressive about looking for ways to move studies along quicker with just different statistical analysis, so they've been very receptive to adaptive statistics. They don't propose anything. I mean, they're always reactive. So we knew that they would be probably very responsive to this kind of design. They have approved a couple of other cases for infectious disease areas and that. So the scientist in me thinks of this is highly elegant, I mean I'm not a MD, I'm a scientist. I've always been interested in using adaptive design in an appropriate occasion, and this was a very good application of it. Don Berry, who is actually the statistician who is kind of the grandfather of adaptive design, is actually the statistician who worked with us on this, and we co-presented it to the Agency. It was kind of a weird kind of collaboration, but the FDA really is seriously interested in looking at ways of accelerating clinical development, and this is a specific tool that I think they're quite happy that people are starting to look at.
Enrollment Rate:
{12:37} Miguel Nakamovitz: Thanks. And then just one final question in terms of the rates of enrollment: I mean, for the first Phase with the fixed number of patients, obviously it's the second Phase that will depend on how the thing adapts, but could you just give some remarks there about how long you think the study will take to enroll?
Brad Thompson: We're hoping to enroll 10 patients a month for the first stage, so the primary enrollment should take 8 months … assuming we get the number of sites we want on, and everything like that, and it looks like we should be able to do that. So, 8 months for the 80 patients.
The second stage, we're aiming to double that enrollment on a monthly basis, and we'll be bringing on additional sites while we're doing the first stage, in anticipation of the second stage ongoing. So we'll have that 8 month period to double up on the site number that will be involved with the second stage of the study. Assuming it's the 200ish patients at 20 patients per month, you're looking at a 10 month primary enrollment for the second stage (for the most statistically likely). It could be as short as 5 months if it's 100 patients, and 20 months if it's 400 patients, but 200 in the second stage is the most likely enrollment.
Start of Enrollment:
{13:40} Miguel Nakamovitz: Got it. And just one final question … Is it your anticipation that we could see the first patient enrolled in this study by the end of the first quarter?
Brad Thompson: With a bit of finger crossing luck, and stuff like that, that is actually possible, though we've resisted giving a forecast of a start date until we're absolutely certain about when it's going to happen. Of course, this UK Approval was a key element of that. We've been going through the process of the US sites since last fall when we got the SPA, so we're very close to having sites enrollable right now, in the States. We want to just have more sites kind of in parallel going on to it, so I think that it's possible we could still do it next month, like Q1, or it might fly into early Q2. So that's why we've been kind of saying H1, 2010 … because whether it's March 31, or April 15, or something, I mean, it's likely to be not far out of that band.
US/UK requirements:
{14:50} Neil Maruoka [Canaccord-Adams]: Based on your preliminary discussions with the European regulators, have they indicated any requirements for approval of Reolysin that differs from that outlined by the FDA?
Brad Thompson: Well, it's identical. We submitted the identical protocol … literally identical, and we had one comment come back just requesting we confirm about the water we used to make the product being made to European standards. In Europe, they distill their water, and in the States they make it by reverse osmosis. Of course, all the manufacturers do both, just so they can sell it to both. That was the only comment we had.
UK start-up:
{15:22} Neil Maruoka: How long a delay do you expect in getting the UK sites on line, compared to the US?
Brad Thompson: Well, the US is a little more linear, so we needed the SPA first before anybody would touch it. The US is, in many ways, the slower jurisdiction to get anything up and running. In the UK we were actually able to parallel track, and we also had the advantage in the UK that many of the sites in the UK had already run patients, either on our Phase II head and neck, or one of the other multiple studies we'd run in the UK. So it's a lot faster process for us to get sites up and running. We're already part way through the process with many of the sites in the UK, so I would expect that a lot of those UK sites will come on near-simultaneously, or very soon thereafter with the US sites.
Site Distribution:
{16:25} Alan Ridgeway [RBC Capital Markets]: What's the breakdown on the number of sites in the US, the UK, and Belgium?
Brad Thompson: I don't have the exact numbers … it's a little bit in flux, but you're looking at around 4 to 6 sites in Belgium, as the anticipation. The Approval process in Belgium is completely different than anywhere else on the planet, so I don't even want to get into that, it's a very much backwards process. The Belgian regulatory authority is almost the last in line, as opposed to other places where they're first in line. Sort of 8 to 10 sites in each of the two other jurisdictions is the current kind of split. That could shift now a little bit. We're getting a lot of secondary interest popping up now, in both the UK and in the US. I think we'll probably put on as many sites as we can in the first part of the study to make sure that we meet or exceed enrollment.
Belgium:
{17:20} Alan Ridgeway: So, on the Belgian front then, will you be starting the Trial before essentially getting approval? Like would you start it in the UK and in the US, and just go ahead and then bring Belgium on when they're ready, or would you wait for them?
Brad Thompson: I think it's more the minimum number of sites … when we get up into the teens with the number of sites that are enrollable, then we'll go ahead and start enrolling, because the other sites will come on very quickly thereafter. Belgium's kind of odd. For all I know, we might actually enroll in Belgium first. It's a very very different process there, and of course with two languages for your filings, it makes it more interesting. The insurance is totally different. I've learned more about insurance in the last two months in Belgium than I thought I knew totally. It's just a different jurisdiction to operate in. We could start actually start enrolling in Belgium, with the way things are going, before the other two countries if we wanted to. It's a very dynamic process right now.
Patient Distribution:
{18:06} Alan Ridgeway: And as far as a breakdown of geographies for the first 80 patients … it doesn't matter at all? … you just enroll 80 where you can get them?
Brad Thompson: Yup, that's exactly correct. The only thing you have to watch out for when you're running multi-jurisdictionals is that you file in the US first. The FDA is … "rather reluctant" would be an understatement to Approve studies, and to join already existing studies, whereas the other jurisdictions aren't, so that's why we filed in the US first. Once we got the SPA in the States … that was kind of locked in stone, and we went ahead and filed in the other jurisdictions.
Total number of Sites:
{18:37} Alan Ridgeway: And now when you talk about doubling the number of sites, you're talking about potentially going up to 50?
Brad Thompson: Yup. We're trying to be very cautious on the number of patients per site enrolled. If you had 25 sites, and break it into 80 patients … If you're only counting on a site enrolling a patient every two to two and a half months, then you'd comfortably meet your enrollment for that time period. Sites always say they can enroll faster than they do, in our experience, and we're actually using the enrollment rate that we're actually getting out of our existing studies, then downgrading the time on that and using that as our calculation to come up with the number of sites
NSCLC:
{19:15} Alan Ridgeway: On the non-small cell lung cancer in the US … the Phase II, with the 3 new sites could you potentially give us an update on when you might think that that would be enrolled, and when we might see some data from that study?
Brad Thompson: I think that the bulk of the enrollment should be done next quarter, and certainly enough that we'll have enough data to be making some decisions about what to do with that moving forward. So I think we could get a preliminary read on the data as early as the end of next quarter, because the primary response rate is the primary outcome of that study … so you get a very quick read on the patients … whether they respond or not.
It's an interesting study. You're pre-screening, which is something we've never been able to do before. When we first started studies in Canada, very early on, we were specifically prohibited by Health Canada from pre-screening, and the screening technologies (for EGFR in particular), were rather not usually held in those days, and nobody knew the importance of KRas to start off, and now, we can actually pre-screen rather efficiently for the first time, there's an actual linkage with important indications that people didn't know about, and I'm just thrilled that we actually have a study where we can actually pre-screen patients, and see that pre-screened patients, Carbo/Tax which does the immune system "knockdown" thing that is helpful, that makes tumors leaky which is helpful, and they work in synergy with Reo on an individual basis in the lung, where Reo is preferentially cleared.
You might expect that I have some fairly high hopes for that particular study, but the pre-screen part is really a major step forward for everybody in our field, and specifically for us it's quite helpful.
Trial Cost:
{21:08} David Miller [Biotech Stock Research]: How far into the Pivotal Trial will your current cash resources get you?
Brad Thompson: We have enough cash to do the full 80 patients, and the full data analysis on the 80 patients. So, you're looking at about a 6 month window after the last patient is enrolled, which gets you certainly past a true response rate, true PFS, and the Kaplan-Meier should have spread far enough based on the anticipated death rate to get a full data analysis on that. We'll be actually enrolling patients in the second stage during that, and our burn covers off on that as well. That means, if you're looking at a milestone perspective, that gets us to that point.
It costs us around US$70,000 per patient for that study, and so you're looking at the primary enrollment in the first 80 patients is US$5.6 million, and you're probably enrolling another 50 – 60 – 70 patients at least into the second stage; so just to make the numbers easy, you're adding another $5.6 million of enrollment while you're waiting on analysis on the first part.
Partnering:
{22:25} David Miller: What's the current status on partnership talks?
Brad Thompson: We're talking. Getting the SPA was very helpful. I think it really helped lead to, at least the perception of decreased regulatory risk. We've been having people tell us for quite some time that they believed that the agent's clearly active, and I think that that's the case … you can make it, and it's safe, and we've got a great IP base and all that sort of stuff, but with a perception that with a new class of agent, and in this case a live agent … you know: what would the FDA do … and the SPA answers that question. The SPA had other uses than just getting the FDA to approve it, and I think that it's bearing some fruit in the partnering world.
David Miller: Do you have any sense of when one of them is going to bite … you know: in the middle of the initial phase, after the initial phase, after you've already figured it out?
Brad Thompson: I think that we have companies indicating all of those options that we're currently discussing things with. Some people would prefer that we don't have Phase III data before they partner with us because of course that changes the price tag. Some are actually more interested in the non-small cell lung than they are in the head and neck, so I think there will be some interest exhibited there later … the middle of the year hopefully we'll have interim data, again under confidentiality, that people are seeing our data in real time … so they'll know more about it than anybody on this call except for me. Or the equivalent of "my hair's wet" on a date request, which means they want pivotal Phase III data which means I don't need them anymore. Most of the people at the table are in those first two categories: they would prefer us not to have [Phase III] data, or are waiting for non-small cell lung data.
Uniform Enrollment:
{24:08} David Miller: One of the things that occurs to me with this Trial design is if you end up having a not linear Trial enrollment, or a back-end loaded Trial, that the initial look might be a little difficult. Is there any adjustment in statistical procedures, or otherwise, that you can look at that?
Brad Thompson: You can readjust the stats. I mean, you can always readjust stats, as long as the overall statistical plan is careful. It's best if we stick to the 10 per month. If it goes 2 per month, and then 60 patients in the last month, then we'll have to insert a bit of a wait there, at the end, clearly. But as long as we stay within broad parameters around that sort of 10 per month range, then we'll be ok. So that's just probability. On that poster session – I can't remember when it was … the last time we talked about the Phase II data out of the UK, we segregated the data, the investigators didn't have a clue why I wanted to do that, but I mean, I have reasons because I think stats. And there was a clear linkage, beginning to show between response rates and lifespan in those 19 patients, and that's continuing to develop and it's getting more accentuated, and there's always been a clear linkage between response rate and time to progression obviously. We're pretty confident that as long as we stick close to our enrollment that we'll have the kind of linkage that you need really to do, with adaptive design.
{25:44} David Miller: Are you going to update us on the number of patients you have enrolled as you go along?
Brad Thompson: Absolutely! I'm going to have fun doing that. I don't normally, as you know, talk about how many patients we have as we go along, but I'm planning to let people know about enrollment as we go out, as it's important for people to evaluate it, and for timelines with respect to other reasons.
Next Presentations:
{26:00} David Miller: Can you talk about when and where the next Reolysin data presentations might be?
Brad Thompson: No I can't. <round of chuckles here> We're waiting here for a couple of things for ASCO, and we're waiting to hear on a couple of things for other meetings, and some of the studies will be reporting sooner than expected, and some will be reporting later than expected. It's pretty dynamic. We have a number of sites that will be reporting this year, which I'm very much looking forward to.
And in summary …
{26:45} Brad Thompson: Well, I'd just like to thank everybody for joining us today. I think we really have a, I would say … interesting year ahead of us at Oncolytics. We have a number of our earlier stage studies, and other kind of interesting studies that will be reporting, and I can't tell you how thrilled we all are to be finally, right on the cusp of starting to enroll in our first Phase III study. So, again, I thank everybody for their attention, and interest in our company over the last few years … and stay in touch, `cause it's gonna to be fun.
RBC Capital Markets presentation Q/A Transcript
from Brad’s presentation at the RBC Capital Markets' Healthcare Conference in New York, The panel was titled "Cancer: Improving Treatment Through Combination Therapy."
Thanks to RJC for the transcript
----------------------------------------------
This is a full transcript of Brad's parts in the four company (plus moderator) panel presentation on Mar 3, 2010 at the RBC Capital Markets' Healthcare Conference in New York. The panel is titled "Cancer: Improving Treatment Through Combination Therapy."
The panel discussion can be heard at: http://www.wsw.com/webcast/rbc116/panel15/
Introduction
{6:22} Brad Thompson [Oncolytics Biotech]: Oncolytics Biotech is a company that's focusing on using a variety of different viruses for the treatment of a variety of different cancers. Our lead product, called Reolysin, is about to initiate its first Phase III study (hopefully in about 3 weeks), in the UK, the US, and Belgium; and we're looking at platinum refractory head and neck cancers in combination with Carbo/Tax.
We have a number of Phase II studies running. We're running a Phase II in non-small cell lung cancer in combination with Carbo/Tax, and metastatic melanoma in combination with Carbo/Tax. We're about to initiate a Phase II in colorectal cancer, in combination with Carbo/Tax again (our favorite drug combination), and a pancreatic cancer study … a randomized study where we're comparing Carbo/Tax/Reolysin against Gemzar, and the third arm is Carbo/Tax alone. It's an interesting time for us, and like my colleagues on the panel here, it's nice to be in Phase III's, or starting Phase III's finally.
Early Challenges
{12:40} Alan Ridgeway [RBC Capital Markets]: Oncolytics probably can be considered the leader in live virus therapeutics for the treatment of cancer. Can you talk a little about the natural attributes of Reolysin, and why it makes a good cancer therapy.
Brad: I think that there are a number of challenges, which my colleagues on the panel, have already talked about … starting out with a new agent and a new therapeutic, and using a live agent is amongst those areas. We're using a naturally occurring virus that affects your lungs and your bowels normally. I think the challenge for us has been overcoming … the term could be "not very relevant" worries about safety, primarily, and while retaining enough efficacy, we're keeping a balance in place. And so very early on in the program, we had to go that extra yard in insuring that we had a "more than acceptable" safety profile. We did way more animal tox [toxicology studies] than you would expect ... hundreds of primates, and now that we're up into about 370 or 380 patients in total treated in our IV program, you start to get a kind of a settling down about those concerns and issues about safety. We understand the safety profile about our drug candidate extremely well, and that's very helpful.
Now for us, we picked a naturally occurring virus as opposed to an engineered virus to get around some of the issues we saw on the horizon with respect to using engineered viruses. And that's, I think, born fruit. A lot of the regulations associated with the use of these agents are directed toward the fact that they're genetically engineered, and we've just skirted around that by using a non-engineered virus. So what we have is an agent that's safe … I mean, I think we've taken it beyond a shadow of a doubt. Now that we've got a SPA for our Phase III (which was our route), I think the regulatory concerns have kind of drifted away. The FDA is quite comfortable with this concept now. Our European colleagues have never been concerned about it. We've never had the kind of issues in Europe that we've had to deal with in the United States, and now people are just considering this to be another drug candidate, which is exactly what we hoped we would get to.
I think for us, having made a drug approval in this area [short mumble] immunize things in Europe, so there's no path. Again, a common feature with new agents is you're making up your path as you go up blind allies. There are just things that you have to do, that you don't know you have to do until you stumble across them; and I've never actually done as much science in humans as I've done on this project. Usually you do that before you get into humans. Pretty much everything we've learned about the basic science of this agent has been in human clinical studies, and I think that's a significant feature.
Advantages of Co-Therapy
{25:56} Alan Ridgeway: Reo, in combination with chemo really helps, is what you've been able to find, really helps the virus function and work as an anti-cancer agent. Can you talk a little about what you have learned over the years with your combination therapies?
Brad: What we (as it turns out) naively thought when we started out, was that we could take our single agent and put it head to head with everything, and be quite pleased about that … that was based on the fact that Reolysin requires an activated Ras pathway to grow in a cell. So if you look at solid primary tumors, it's [Ras active for] two thirds to 75% of each one of those, and if you look at metastatic disease it's between 90% and 100% typically. It's somewhat lower in non-solid tumors, and that's why we've stayed away from them. When we did local therapy, injecting the virus directly into the tumors, we actually got response rates that mirrored that, and so we proudly put up our hand, and charged into mono-therapy studies.
When you get to IV studies … you kind of end up balancing commercial issues with respect to activity issues. If you want to treat first or second line patients, you're compelled to look at combining yourself with "standard of care". And for us, it's radiation, and the first line and second line chemo-therapeutics. So we started looking (back in the lab) at synergies at a cellular level, and also looking at tumor effects above that level. When we started looking at IV monotherapy studies, we found that the response rates were about half of what we saw with local therapy. So it was obvious we had a delivery issue. So, between the vein and wherever, there was something happening with the virus that was not good for activity. Combination therapy overcomes that. The two issues with viral delivery, and we're talking about a particle here that the immune system recognizes. So the immune system can interfere with it between the time you put it in, and the time it gets into the tumor; then you have to get across the tumor interface. If you think you have trouble getting a drug into a tumor, try taking something that's 80 or 90 nanometers across and you can almost hold that up and see it. It's complicated.
But as soon as you add in things that knock down the immune system a bit, that gets out of the way; and Carbo/Tax ablates response against Reo by about 90%, Gemzar is about the same, cyclophosomide's about the same, so those agents actually address any immune interference. And anything that makes the tumor leaky gets the virus in, so Taxanes are exquisite at that; and if you get into any of the VEGF, or VEGF by itself … you know, Sudent or Avastin do the same thing. What we found, is by combining with those agents in humans, and combing those two effects, we boosted the response rate back pretty much to the theoretical again. So instead of getting the 30%-35% of the mono-therapy, we're getting clinical benefit rates up between 65% and 90% with true strong responses … strong PR's and CR's in the 45% to 50% range … pretty much across all indications. The technology of the combination therapy really is the way to go, both scientifically, and commercially for us.
Partnering
{40:15} Alan Ridgeway: Can you comment on what you're currently seeing in the partnership process? What is it that Oncolytics is looking for in a partner, and what do you think would be the ideal time for you to partner with a large commercial Player?
Brad: We went away and did essentially the same analysis as Scott described, with respect to whether, and when, one should partner. In our case, if you have a partner commit to two extra big programs (if you look at that 3 to 15 year horizon, with respect to cash flow per share), if you get that commitment on a fully diluted basis it's about twice the cash flow per share over that entire period, with a partner under your wing. I think there's some good hard economic reasons to partner with respect to things that end up mattering (supposedly mattering anyway), to most of us somewhere down the road, such as shareholder value. That's driving our direction on that, so we believe there's a good economic reason to do that.
We've had kind of an interesting situation with this particular product, because it's curious (and honestly, most people thought it would fail miserably, early on), but it was so curious … we've had a number of our colleagues, companies on the big side looking over our shoulder through the whole process and offering helpful (and sometimes not very helpful) suggestions about what we should be doing or not doing. So it's going to be one of those evolving partnering processes rather than, you know … "today we're going to start partnering, and introduce ourselves". When you get down to the point where you're talking about your kids going through 8 grades or 10 grades of school, over a process, you know that you've been talking with people for kind of a long time, and that's kind of where we are right now. I think that the sweet spot for us to partner is sometime between now and the first Phase III data, which will come out on the first part of our Phase III study about a year from now. If we go past that window, then we'll take the Phase III study in Head and Neck to the end, and that will be the next opportune moment for partnering.
The economics don't really matter to us … either of those two windows. There's a group of companies that are very much interested in partnering with us before we get Phase III data, for economic reasons. There's another group of people that are very much more interested in our non-small cell lung data. There's basically two groups of people, looking at two different timelines. But clearly, if you can't stand and justify it on an economic basis from a shareholder perspective, then one should not partner. Both strategies work, and for some companies, I think that when they do that analysis, they would be surprised that the answer is they shouldn't partner … they should be stand alone, they should be a specialty unit, and have a hugely good case about focusing and doing things themselves. I think we've done a very good job of that. You can do that mathematically … we've sat down with analysts and sometimes there's very good case, and sometimes you get mixed models where a partner will fit with some products and not with other products. But if you do that analysis and the answer comes up "yes", then that's where you are, and that's where we are, and it clearly works for us. That's the process that we're going through. We're very active in discussions … it gets cliché, but we're very active in discussions, but we will do it when it's the most benefit to our shareholders."
The Future
{48:44} Alan Ridgeway: "I just thought, in order to finish off our discussion, I'd ask each of you to comment for investors: what's your vision of the company; where do you see it 3 to 5 years from now, and what can we look forward to over the next 12 to 18 months as far as milestones?"
Brad: "Clinical milestones in the next 12 to 18 months … we'll have our Phase IIIa data for the platinum refractory head and neck out, we'll have our first line non-small cell lung study with K-Ras pre-screened patients in Phase II out, our metastatic melanoma for Phase II in combination with Carbo/Tax out, and we'll be in several other randomized studies at that time. If you're looking at "end game" (and we're just actually starting talking about end game issues … which for us is about a 3 to 5 year period), and I think, clearly, that we'll have our first product … indication … being sales, and we'll be partnered, and our expectation is that we'll probably be sold within that timeframe. We're thinking about that last element quite a bit right now."
RBC - Next 12 Months Likely Transformational
We believe 2010 and early 2011 will likely be transformational for ONC as the company has multiple potential catalysts occurring over the next 12 months that may impact investor sentiment.
These include:
1. The initiation of ONC's first phase III pivotal trial in H&N cancer in the coming weeks that should produce interim phIII data in ~12-14 months.
2. Data released from ONC's NSCLC phII trial around mid-year that we believe will be positive based on the design of the trial, and potentially data later in the year from the company's phII metastatic melanoma trial.
3. The initiation of additional phII trials in colorectal cancer, pancreatic cancer, and squamous cell lung cancer.
4. A potential partnership deal.
Model Revisions: We have made minor changes to our model following the release of the Q4 results. Our updated 2010 and 2011 EPS are ($0.32) and ($0.20), respectively, vs. ($0.27) and ($0.18) previously.
Outlook Unchanged: Focus Is on 2010 News Flow. Based on the data released to date, we believe ONC's lead product, REOLYSIN, has the potential to treat multiple cancer indications. In the coming quarters, a number of events discussed above could provide catalysts for the stock and we believe a potential partnership
deal could be finalized at any time following the initiation of the phIII trial.
While the exact timing of a partnership is uncertain, management has previously indicated that they are in discussions with multiple parties and that each has different interests regarding timing and the data they require. We believe management is in a relatively strong negotiating position given ONC has the capital required to generate the initial phIII data in H&N and should have data (expected to be positive) from the NSCLC phII around mid-year. As a result, we maintain our Outperform, Speculative Risk rating and believe our conservative approach provides for additional upside beyond our forecasts.
Valuation: Maintaining $5.00 target.
Priced as of prior trading day's market close, EST (unless otherwise noted).
Valuation
Our price target is based on a 15x multiple to our 2016 EPS estimate of $1.67 (previously $1.68), discounted at 30% for six years to arrive at $5.18 ($5.23 previously). Our target is supported by a SOTP DCF value of $5.03/sh (risk weighted, 70% probability of success for REOLYSIN in H&N) (previously $5.10/sh). Our multiple and discount rate are typical for what we would use to value other development stage cancer companies in the current market environment. In addition, we believe a number of catalysts exist that could lead to considerable upside including further positive clinical data that confirm the response rates observed to date, the possibility of faster timelines to approval than we forecast, and the eventual approval in additional indications including NSCLC, sarcoma, melanoma, and others.
Prostate cancer trial research published by Morris in AACR
Journal
http://www.eurekalert.org/pub_releases/2010-03/aafc-rmb030310.php
Dr. Don Morris
Public release date: 9-Mar-2010
Contact: Tara Yates
tara.yates@aacr.org
267-646-0558
American Association for Cancer Research
Reovirus may be a novel approach to prostate cancer treatment
PHILADELPHIA — Researchers in Canada have detected a novel oncolytic viral therapy against prostate cancer with use of a virus called the reovirus, according to study results published in Cancer Research, a journal of the American Association for Cancer Research.
The respiratory, enteric, orphan virus (commonly known as reovirus) is a non-attenuated, environmental virus that has shown oncolytic potential against many types of cancer, specifically lymphoid, ovarian, breast, pancreatic and high grade glioma cancer, according to the study. This is the first time the virus has been studied against prostate cancer.
"The reovirus is a very common, ubiquitous virus that most people are exposed to. As far as we know, it doesn't cause any significant illness in humans, even though when someone is exposed to it, it manifests, at most, as a mild respiratory infection or mild diarrhea," said researcher Don Morris, M.D., Ph.D., medical oncologist in the Department of Oncology at the Tom Baker Cancer Center in Alberta, Canada.
"For the treatment of localized prostate cancer, we found that the reovirus is safe and has evidence of specific tumor vs. normal prostate cell efficacy," added Morris.
Using preclinical and clinical settings, Morris and colleagues examined the efficacy of the reovirus as an experimental therapeutic for prostate cancer in vitro and in vivo. Among the six patients who participated in the study, all had early-stage, organ-confined prostate cancer. Each patient underwent a single intralesional virus injection into a suitable prostate cancer nodule via transrectal ultrasound guidance. Three weeks later, Morris and colleagues removed the prostate as part of the patient's standard treatment for correlative science analysis.
Findings showed safety and efficacy with minimal toxicity and no viral replication in the normal parts of the prostate, according to Morris. Cancer cell death was evident in the prostate. Studies to date have suggested that the virus' side effects are relatively modest, consisting of mild, self-limiting, flu-like symptoms.
"Our results are a stepping stone into future prostate cancer clinical trials with another category of cancer therapeutics," he said.
Robert Clarke, Ph.D., D.Sc., professor of oncology at Lombardi Comprehensive Cancer Center at Georgetown University and an editorial board member of Cancer Research, agreed, stating that he believes this study is worthy of subsequent clinical trials of the reovirus as a possible way of treating some prostate cancers.
"People have known of this application of the reovirus in trials, but no one to my knowledge has conducted studies in prostate cancer," said Clarke, who was not associated with this study. "I think this is an interesting approach. There is not a lot done in oncolytics, but clearly it is an area that is getting increasing attention, and we need everything we can get our hands on to make a difference in these patients."
--------------------------
This is from Oncolytics first Phase II trial and was very small in 6 patients were treated. It was conducted some 6 years ago but is significant in that this has been picked up on many new wires outlets.
See some related links below reporting this research.
UK Telegraph
'Tame' virus could prove prostate cancer weapon
http://www.telegraph.co.uk/health/healthnews/7406772/Tame-virus-could-prove-prostate-cancer-weapon.html
CBC.CA
Virus can attack prostate cancer
http://www.cbc.ca/health/story/2010/03/09/prostate-cancer-reovirus.html?ref=rss#ixzz0hjtPPdz6
VIDEO NEWS item on CBC News
http://www.cbc.ca/video/#/News/ID=1436463667
This video featuring Dr. Patrick Lee, Morris and Coffee
WebMD article published
Tumor-Melting Virus vs. Prostate Cancer
Reovirus Is Harmless -- Except to Many Kinds of Cancers
http://www.webmd.com/cancer/news/20100309/tumor-melting-virus-vs-prostate-cancer?src=RSS_PUBLIC
IMO it seems like volume really increased the last 4 trading sessions and was a pleasant surprise today after spiking yesterday to 3.42 before pulling back. It is great to see this news coverage also being covered in Indiatimes and others.
RBC Capital Markets' Healthcare Conference Panel
The Palace Hotel New York, March 3rd panel titled Cancer: Improving Treatment Through Combination Therapy
Brad Thompson CEO of Oncolytics was invited to be on this panel discussion which was webcast. You can listen to the 4 Person moderated panel discussion at the following Wall Street Webcast link.
http://www.wsw.com/webcast/rbc116/panel15/
Listen to Brad and the other panelists talk about current clinical trials including news from Brad of a planned 3 arm trial for Pancreatic cancer with Reolysin+Carbotax, hear about the challenges in the development of Reolysin and other compounds that are new agents, thoughts on partnering --- Lots of good stuff here! and what is expected in the next 12-18 months --- for ONCY Phase IIIa (80 patient) data from H&N, a potential partnership and then in the next 3-5 year range a partnership and/or potential sale of the company.
Quite a long discussion but very informative and diverse points of view from 4 different companies.
Listen to today's clinical update conference call w/Q&A
http://www.integratir.com/presentations.asp?ticker=t.onc
Conference Call Details
Dr. Brad Thompson, President and CEO of Oncolytics, will host a conference call and webcast today, February 16th, 2010 at 2:00 p.m. MT (4:00 p.m. ET) to update investors on the Company’s ongoing clinical program for REOLYSIN. To access the conference call by telephone, dial 1-647-427-7450 or 1-888-231-8191. A live audio webcast will also be available at the following link: http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2967140 or through the Company’s website at www.oncolyticsbiotech.com. Please connect at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed. A replay of the webcast will be available at www.oncolyticsbiotech.com and will also be available by telephone through February 23rd, 2010. To access the telephone replay, dial 1-416-849-0833 or 1-800-642-1687 and enter reservation number 57104101#.
http://www.integratir.com/newsrelease.asp?news=2131023165&ticker=T.ONC&lang=EN&ny=on
Some highlights for me....
I listened to this call and came away very impressed with the Q&A from Rodman and Renshaw who recently downgraded the company, David Miller and others. It was interesting to hear about the planned H&N Phase III trial timeline details and how they are fast tracking getting trial sites up and running in the EU/Belgium while starting the US enrollment sites. We heard about the plan for between 25 and 50 clinical trial sites being utilized to minimize the trial length. We also heard there has been interest from "additional" trial locations in the UK and US that apparently want "in on the testing".
The plan that was laid out for this H&N trial as I heard it was to enroll 80 patients in approx 8-10 months, (4 per site based on 20 initial sites at 2-2-1/2 months per patient)plus 6 months data analysis should get you to 14-16 months from lets say May this year. This puts us somewhere at July 2011 conservatively.
We also heard about "active" partnership talks with parties that fall into three categories. 1. Partner before data is known 2. Partner when interim data is known and 3. Partner when full data is known and analyzed. Brad indicated that most of the interested partners were in category 1 or 2 as he alluded that the required partnership price would likely be higher as risk of approval is reduced as full data is known. He also said that all parties with signed Non-disclosure agreements have access to trial data in near RealTime so any partnership offers would be flowing during the next 2 - 14 months. The real key here is how much the offer's are and how much we are willing to take. Should make for a very interesting upcoming remainder of 2010.
Other update was that some of the interested potential partners were more interested in the NSCLC clinical trial and he outlined the progress of this trial as well. A very good update.
Oncolytics WSJ Mention
Oncolytics Shares Leap For Second Straight Day On High Volume
http://online.wsj.com/article/BT-CO-20100209-712667.html?mod=WSJ_World_MIDDLEHeadlinesAmericas
By David Benoit
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Shares of cancer-treatment developer Oncolytics Biotech Inc. (ONCY) have soared this week as increased attention has led to growing excitement about the company's pivotal upcoming clinical trial for its head and neck cancer treatment.
Shares of the Calgary company were recently up 11% to $2.90 on nearly six times their typical trading volumes, a day after jumping 9.6% on nearly three times the typical amount of trading. The stock has now gained 23% so far this month, and earlier Tuesday crossed back above $3 for the first time since the middle of November. The stock had fallen after the pricing of an equity offering in November, which was to raise cash for the coming trial.
Analysts said there wasn't any specific fundamental change to explain the move Tuesday, but said investors have long been looking toward a late-stage study on Oncolytics' critical cancer therapeutic, Reolysin, for head and neck cancers. The treatment employs a virus that can target the cancerous cells.
Over the weekend, business news Web site DailyFinance.com posted an article featuring a largely positive interview with Chief Executive Brad Thompson. The story explained how Reolysin works and quoted Thompson as saying it is "rather straightforward" and has minimal side effects.
"Normally, the latest we ever find the virus in the body is a couple of weeks after the first injection, and then it's completely gone," Thompson said, according to the article.
The article also said a partnership could be announced by the end of the Phase 3 trial, which would mark a significant accomplishment for Oncolytics.
A spokeswoman for Oncolytics said she has received growing interest since the article appeared this weekend, including increased phone calls and emails about the treatment. She said that often happens with news stories about the company.
Thompson was also presenting at a conference held in New York on Monday, delivering the company's typical presentation on Reolysin's potential.
Versant Partners analyst Douglas Loe said he didn't know of anything specific to drive the shares Tuesday, but after initiating coverage recently, believes the stock could trade closer to $4.25.
-By David Benoit, Dow Jones Newswires; 212-416-2458; david.benoit@dowjones.com
Banque Nationale du Canada/Cannacord Coverage for ONC
Two additional analysts upgrades last few weeks.
Jan 29th "Banque Nationale du Canada" raised their recommendation from buy to strong buy this morning.
Jan 4th, 2010
Cannacord - Target $4.50
INITIATING COVERAGE
Oncolytics Biotech (ONC : TSX : $2.62) - Buy - Target: C$4.50 Neil Maruoka
Comment: Harnessing the virus to kill cancer; initiating coverage with a BUY
rating and a C$4.50 target price
We are initiating coverage on Oncolytics with a BUY rating and a C$4.50 target. Oncolytics is a Phase III biotech company developing a novel drug for the treatment of cancer. Reolysin, the company's lead product, is about to enter Phase III and has received a SPA from the FDA. We believe that the SPA from the FDA greatly reduces the regulatory risk associated with Reolysin. An SPA is an agreement between the company and the Agency outlining the Phase III trial design. If the Phase III study reaches its pre-specified endpoints, the SPA suggests that this should be sufficient to support approval. Although there are many other factors in the approval of the drug (most notably, the safety profile), the SPA significantly lowers this major regulatory hurdle. We also believe that this particular SPA demonstrates that the FDA is open to new approaches to trial design. The SPA for Reolysin contains a protocol for an adaptive study, in which the company can use a preliminary data analysis to support the parameters of the second portion of the study. Reolysin is a live virus with the unique ability to replicate in many types of tumour cells. Our review of clinical data generated so far suggests that Reolysin is a promising drug, having produced encouraging data in Phase II studies, as well as compelling results in individual patients. We have valued Oncolytics using a probability-weighted NPV (pNPV) model for the company's lead drug for the treatment of cancer. We have assigned a 45% total chance of success for Reolysin in squamous cell carcinoma of the head and neck (SCCHN), and a 25% chance of success in non-small cell lung cancer (NSCLC). We then discount probability-weighted peak profits by 15% and apply a pharma P/E multiple of 11x to this value. Using this methodology, we arrive at a target price of C$4.50 for Oncolytics, which supports our BUY recommendation.
BIO CEO and Investor Conference Presentation 3PM ET Today
Media Advisory - Oncolytics Biotech Inc. to Present at 12th Annual BIO CEO & Investor Conference
CALGARY, Feb. 4 /PRNewswire-FirstCall/ -- Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview of the Company at the 12th Annual BIO CEO & Investor Conference on Monday, February 8, 2010 at 3:00 p.m. ET. Hosted by the Biotechnology Industry Organization (BIO), the 12th Annual CEO & Investor Conference will take place February 8th and 9th at the Waldorf-Astoria Hotel in New York.
A live audio link to the webcast presentation is available at:
http://www.veracast.com/webcasts/bio/ceoinvestor2010/35112252.cfm , or on the company's website at www.oncolyticsbiotech.com. It is recommended that listeners log on 15 minutes in advance of the presentation to register and download any necessary software.
An audio replay will be accessible approximately one hour following the presentation on the Oncolytics website.
About the BIO CEO & Investor Conference
Now in its twelfth year, the BIO CEO & Investor Conference 2010 is the largest investor conference focused on the biotechnology industry. The conference provides a forum for public and private equity investors, research analysts, investment bankers and senior-level industry executives to learn about and discuss investment trends and investment opportunities in the biotechnology industry. This year's conference will feature corporate presentations from more than 120 companies, workshops featuring leading experts on specific therapeutic and technology topics, plenary and panel sessions on timely business issues and industry trends, many opportunities to schedule one-on-one meetings, as well as numerous networking opportunities. For more information, visit www.ceo.bio.org.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN(R), its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
The presentation and webcast times are subject to change. This release and the presentation related thereto contain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control and which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward-looking statements. Such risks and uncertainties include, among others, the efficacy of REOLYSIN as a cancer treatment, the success and timely completion of clinical studies and trials, uncertainties related to the research and development of pharmaceuticals and uncertainties related to the regulatory process. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward-looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.
Source: Oncolytics Biotech Inc.
Cardica - Microcutter/Stapler
While we are all waiting for any kind of news I came across an interesting look at some of our competition's newest technology and in the presentation the competitive landscape of the stapling market in general.
Cardica Microcutter Presentation
http://www.cardica.com/presentations/microcutter/player.html
Interesting there is a mention of BiPolar sealing during the last few slides.
onco_investor
Versant initiates Oncolytics with buy...Target C$4.25
https://research.tdwaterhouse.ca/research/public/Markets/NewsArticle/1314-SGE60R0JK-1
Jan 28 (Reuters) - Versant Partners initiated coverage of Canadian drugmaker Oncolytics Biotech Inc <ONCY.O> <ONC.TO> with a "buy" rating on the prospects for its cancer therapy, which were supported by positive mid-stage trial data.
Last October, Oncolytics reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a late-stage trial for reolysin to treat patients with head and neck cancers.
The brokerage said Oncolytics has a "clear critical path to approval now established with SPA-endorsed Phase III head & neck trial."
The therapeutic cancer therapy is poised to enter phase III in the first half of 2010, Versant said in a note.
The brokerage expects the pivotal head & neck cancer testing to conclude by the second half of 2013, and the FDA to approve the drug by the second half of 2014.
However, Eli Lilly and Co's <LLY.N> colon cancer drug Erbitux -- an approved alternative -- could dampen reolysin's market potential, it said.
Shares of the Calgary, Canada-based company were trading up about 5 percent at C$2.38 Thursday on the Toronto Stock Exchange. (Reporting by Juhi Arora in Bangalore; Editing by Maju Samuel)
---------------------
and
From DJ Newswire
Oncolytics Started At Buy, $4.25 Target By Versant >ONCY
Dow Jones Newswires (212-416-2400)
01-28-10 0749ET
Copyright (c) 2010 Dow Jones & Company, Inc.
---------------
Versant Partners ... from their website regarding their Biotech analyst Douglas Loe
http://www.versantpartners.com/en/team.html#
Douglas Loe, Ph.D
Biotechnology & Health Care
Doug is a consistently topped ranked healthcare and biotechnology analyst. He has covered Canadian biotech since 2000, initially as part of the research team at Yorkton Securities (now Macquarie Capital Markets), and then with Versant starting August 2002. Doug holds a MBA from Queen’s University and a Ph.D. in biochemistry from the University of Guelph, working in the area of cancer chemotherapy and multidrug resistance, followed by post-doctoral training at the Queen’s University Cancer Research Institute. Prior to commencing his career in financial analysis, Doug worked as a consultant to Molecular Mining Corporation and MDS Inc. During his scientific career, he published 24 abstracts and 17 peer-reviewed manuscripts and review articles related to P-glycoprotein and MRP-mediated multidrug resistance.
(416) 849-5005 | email
What pharma wants - 2007 Article in Nature
http://www.nature.com/bioent/2007/070701/full/bioe.2007.2.html
Pharma has pipelines to fill and cash to spend. But just what types of partners and products is it looking for?
With pharmaceutical companies partnering with biotechs at a heated pace, biotechs are considering the factors used in benchmarking drugs and wondering what are the best ways to present programs under development. In this article, two pharmaceutical executives, three biotech CEOs and a healthcare veteran provide insights into today's partnering environment. What follows is an abridged transcript of a Bioentrepreneur roundtable discussion convened at BIOEurope 2006 at the Hilton Hotel, Dusseldorf, Germany on November 5, 2006, which was sponsored by Merck, based in Whitehouse Station, New Jersey. The following transcript has been edited to address the major themes discussed.
.....
What are the key ingredients in licensing deals?
Ray Hill is executive director and head of licensing and external research at Merck Sharp & Dohme, the UK subsidiary of Merck & Co.
Ray Hill. Merck has not been involved in a mega-merger and hence these days [it] could be considered a medium-sized, rather than large, pharmaceutical company. Nevertheless, we still have 9,500 staff in R&D and we spend $4.8 billion. Even with this large investment in R&D, we estimate that we do internally about 1% of the biomedical research that we need to know about. So clearly we've got to be outward looking. At the same time, we need to focus and only run one set of R&D objectives. Essentially, the nine therapeutic areas [Alzheimer's disease, atherosclerosis, cardiovascular disease, diabetes, novel vaccines, obesity, cancer, pain and sleep disorders] that we've decided to put 75% of our internal effort into are also the areas that we're most interested in finding licensing opportunities in. We have a clear list of 'wants' and 'don't wants' in those therapeutic areas, which we share with potential collaborators and the VC [venture capital] community. We also have defined 'wants' in the technology arena, because drug discovery is still a competitive high-tech area, and without enabling technology, you can't move it forward.
But when in doubt come and talk to us. When you get a product to phase 2 clinical proof of concept, even if it comes from a strategy that we've decided we don't want to work on internally, we're happy to admit that we're not always right and would be happy to review a data package. And phase 2 clinical efficacy wins every time.
Klaus Wilgenbus is senior vice president, licensing, at Boehringer Ingelheim.
Klaus Wilgenbus. I feel it's not as much what we are looking for from biotech or looking for in terms of content, but in terms of approach and in terms of the 'how'. What we don't want is more genomics hype. My scientific background is human molecular genetics, and I was hired by big pharma with the expectation that the next wave of new drugs will be built on genomics. And there was this huge hype at the beginning of the late nineties around genomics, and I think it was a very sobering experience for many of us because there were huge expectations built around a certain technology that just could not fulfill the promise. So we don't want companies approaching us, or third parties approaching us, vastly overselling their assets. Be real with what you have and let the data speak for themselves.
Rainer Wessel is president and CEO of Ganymed Pharmaceuticals.
Rainer Wessel. For us, what we normally do is we outline what we have done, and then we make it transparent what we are going to do, let's say for a horizon of the next 12 to 18 months. Go in there with a presentation describing that, and then pharma will come back later, in a year or a year and a half and see whether you have done what you promised. Most companies are really following what you are doing, and so you have to build up a certain reputation and then really deliver on that expectation.
Sanjay Kakkar is CEO of Trigen.
Sanjay Kakkar. I entirely agree with Rainer that it's about building up a relationship. I think we all know that, I think we're all mature enough now in this sector, or I hope we are, to understand that you don't get a deal after the first meeting, and don't expect anything to happen quickly. But you can lay out broadly what the opportunity is for your product, and where it is.
It really is about being realistic and understanding your objective, understanding what stage your drug actually is, and what the costs and the risks of getting it to market are, and then understanding your buyer. Really understand what they're after and position your drug as such.
Eva Steiness is CEO of Zealand Pharma.
Eva Steiness. When our team at Zealand Pharma [Glostrup, Denmark] went to out-license an interesting compound, we knew where we were, and we knew what we hadn't done. Big pharma showed up and we did a due diligence with five big companies in one and a half months—that was a burden, I can tell you. But they asked questions relating to their internal barriers for moving one compound to the next step. And being a small biotech company, I can say I think big pharma has to learn who they are talking to. Because biotech is built on venture funds and they don't allow us to do a lot of the things that pharma wants.
R.H. When looking at a product opportunity, it really comes back to this issue of how badly do we want it? And each case is different. If the presented opportunity is in an area where we already have a high degree of commitment internally and especially if the biotech is ahead of where we are internally, then we probably would jump in very early with an expression of interest. If we are cynical about the value of the target, then we're going to stand back and say, "We want to see your phase 2 data." But if we're already convinced that it's a great target, then yes, we will enter early-stage collaborations with a suitable partner.
Alan Warrander is senior vice president, life sciences, Wood Mackenzie.
Alan Warrander. I can think of one deal that I was involved in when I was still with AstraZeneca where we felt that the compound was no more than a proof of principle, something to test a concept with, and it had CMC [chemistry, manufacturing and controls] problems like nobody's business. But nevertheless, we did a collaborative agreement. The company that we dealt with continued, with AstraZeneca's [London] help, to do basic research and look for backup molecules. We moved the lead molecule forward quickly with what I thought at the time was an amazing formulation, we took it into the clinic, it actually was quite successful in the clinic and the compound is continuing to run. So, yes, every case is different.
What is the deciding factor in striking partnerships?
K.W. It's all driven by data. However, I—and not just Boehringer Ingelheim but also our peers—also believe that when we talk to smaller companies, which have completely different needs in terms of pushing things forward, they sometimes have certain gaps in the data. That's not to say there are flaws, but there are gaps. To accept this and go forward into clinical development, we need to understand that we can't expect the same breadth and depth of data from a small biotech company. They, of course, did not do 20 pharmacology studies, which is what we'd do for an internal program.
A.W. I think on the big pharma side, they've got to be open and honest with people in the initial discussions and tell them what their processes are. And if it happens that the process and pharma's requirements are not going to fit with what you as a biotech are looking for, and the timeline isn't going to work for you, then you don't need to keep talking to that company. There are lots of other potential partners out there. But I think one thing that's true is that very often in big pharma, the most difficult negotiation is the internal one.
Because the people representing the biotech opportunity are presenting programs that may have fewer data than internally their pharma colleagues are used to seeing. And so what that does is increase the risk; it doesn't necessarily make it less attractive, but it will affect the valuation. Either pharma will come back and say, "Look, we're really interested in this but we want to see you do the following studies." Or, they'll say, "We're really interested in this but we feel we really have to go away and do these studies. Therefore, this is the value that we're putting on your program." So again it comes back down to communication.
What if a biotech's product looks promising but the data are incomplete?
R.H. Well, at the end of the day it's still all about how much you want something. And if you've come up with an attractive hypothesis internally, and for one reason or another you just haven't been able to find an active molecule that interacts with that target, and you find that a biotech has managed to succeed, then almost any amount of data would be sufficient, so long as they've achieved that initial chemical feasibility or biological feasibility. I think if it's a project where you have an interest in the therapeutic area, but perhaps the mechanistic target is one that you're not terribly keen on, then I think you're going to be a lot more demanding and you'll want to see more data from your potential partner, because you've still got reservations about whether this is a good hypothesis or not.
And I don't see any reason why you can't say, "We had an internal program on this five years ago, and really we were not impressed with the molecules we produced and we dropped it." I think you should share that information with your potential partner, and say, "That's why we're not going to take an interest in a project from outside until you have clinical data, because our own preclinical project wasn't that impressive." And I think you'll find that big companies might be keen on what you're doing, even if you have a very limited toxicology package or even a limited amount of in vivo data. For example, in the obesity area, our gold standard test has been dietary-induced obesity in the rat. That can be a very expensive test that a small company would probably have to pay to have run by an external service provider. But if you come along with an active molecule that you're prepared to supply under MTA [material transfer agreement] and it works at a target we're really interested in, we'll do those studies at our expense. And even if we decide not to go forward, you get those data without paying a CRO [contract research organization] for it. So I think that there are ways forward in most of these issues, if you get the right sort of open and transparent discussion about the needs of both potential partners.
S.K. What you're asking is for that corporate entity to risk $500 million to $1 billion to move into or extend the therapeutic franchise with a product where the costs and the risks are huge, even at the early stages, even at phase 2. And I think this is a problem because what we do as biotech companies is say we're expecting you to do all of this, whereas pharma is saying, "Hold on, it's not ready for us to make that commitment, we have to be able to see a little bit more data, we have to spend more, we have to see the CMC, we have to see the formulation." And I think that a fundamental flaw is that you've got biotech companies that have pushed a certain distance, and our finance will go a certain distance and the expectation of what can be delivered at that point when that financing is complete is lacking in terms of what pharma will commit to at that particular point.
K.W. What you have to sell to your partner is strategic fit. And the good biotechs actually approach us and say, "We know you have this product there that runs out of patent in 2012, we don't see anything in your pipeline, we believe you should be interested in this compound." And then we say, "Yes, you're right," because we have a gap. That's a strategic fit. So that might make us the right partner to do it because we'll be committed. This will help us convince our partner that we will not just shelve it, but that we will develop it because there is a need for both of us to bring this compound to the market as soon as possible.
E.S. The really big problem I see for small biotech is the CMC section, because we need to upscale and that's pretty expensive, and you need to do that in the right timeframe, and that's close to being impossible. We all have to fit with the safety package for clinical development, and I think that biotech companies don't want to minimize that, and that goes for the tox [toxicology] studies, too. But the CMC section I think that is, at least from our experience, one of the major differences between big pharma and smaller firms.
R.H. At Merck, we've gotten to the point where, through an acquisition, we have a compound that is now ready for its first indication. And we have three things in phase 2 and a very strong pipeline. And that's been driven by a very aggressive licensing strategy. But there are things in oncology, like antiangiogenic agents, where we'll just tell you we don't go there; we don't do that. But if you come along with something with phase 2 efficacy without any of the caveats and safety worries that we have about that strategy, then we'll put our hands up and say, "We were wrong and maybe there ought to be a compound with that mechanism in our portfolio." But you can't work on everything and you can't be committed to every hypothesis. And I think we have to share that with our potential partners.
A.W. Certainly, when I was at AstraZeneca—in the oncology and infection area—what we did was identify mechanisms that we were particularly interested in. And we were proactively going out and seeking people who had those opportunities, to find out exactly where the programs were and what they looked like. As a consequence of identifying things we did want, we also had things we really weren't that interested in. And if somebody came along with one of those then it was a case of telling them, "Thanks very much but for these reasons..." But did we publish a list of mechanisms that we did want? No, we didn't. And the reason for that was a lot of it overlapped with what was happening in our own research. And we weren't going to tell the competitors exactly what areas we felt were particularly important.
Does big pharma's interest in biologics signify a shift for healthcare?
R.H. At Merck we went from a culture where we were very much a small-molecule company with the mantra of "one milligram, one tablet, once a day." Now you'll find we're equally receptive to biological approaches using proteins, including antibodies or si[small-interfering]RNAs. Our senior management in R&D has changed and we have a whole different team leading our efforts. Overall, that change in thinking has taken several years in our big company. One advantage of collaboration with the biotech sector is that cultural changes are achieved in weeks or months in a small company and the large pharma partner can benefit from that agility.
K.W. It is not just Merck who has made this transition, but the whole pharmaceutical industry. We are currently witnessing a tremendous endorsement by big pharma, including Boehringer Ingelheim, for large molecules and biologicals. With that we are seeing the merging interest in big biotech and big pharma to bring tomorrow's therapies to the market. There is the common challenge for both to bring true innovations to the market, and we are eventually all in the same boat. In the end, therapeutic advances and not me-too's will drive future pharmaceutical markets. Maybe that's good news for patients, that we all have to act in concert.
S.K. I'm not sure I actually agree with that. I think that society has shown quite clearly that it's not prepared to accept the risk associated with innovation. We see regulators and we see the issues with new therapies coming through, and even the smallest incidence of side effects will have a dramatic effect on how that drug is received, viewed, how it's labeled. I think actually you do see companies succeeding with me-too products. Look at the statins market, the way the statins market has grown and grown and grown. And one could actually argue over the incremental benefit at each point. I don't see me-too as being a situation where there's actually no benefit at all. Most blockbusters have been built on the basis that the first product and second product get there, they establish the approach, establish the marketplace, and then the next company comes along with an incremental benefit. It could be a slightly lower side-effect profile, it could be slightly better efficacy, it could be a better dosage form, but it's something that the market recognizes as something they'll pay for. So I'm not so sure that innovation is rewarded. I think we see that the risk associated with innovation, even once products get to market, are being treated very cautiously in our society now.
R.H. I think we've got into a discussion that to some extent is the dilemma of the pharmaceutical industry right now. What should you work on? Should you pick things you know that you're going to get reimbursed for, or should you pick things which are truly scientifically innovative? Obviously, in an ideal world you'd like to do both.
Bio on Dr Warrander Consulting
http://www.warranderconsulting.com/about-warrander-consulting.asp
Alan Warrander has over 30 years wide-ranging experience and a broad range of contacts in the Pharmaceutical Industry having worked both in Pharma companies and as a Consultant.
Until the end of 2007, Alan was Senior Vice President, Life Sciences at Wood Mackenzie, the global consultancy firm, where he provided consultancy advice and expert scientific opinion to Pharma, Biotech companies, Finance groups and Law firms primarily in the areas of Partnering, Due Diligence and Strategic Planning. Alan was also responsible for the production of a number of Expert Reports on a range of companies in support of potential AIM flotations.
Prior to joining Wood Mackenzie in mid-2005, Alan held the position of Director of Global Licensing with AstraZeneca where he covered all aspects of partnering (Evaluation, Due Diligence and Transaction Management) for the Oncology and Infection Therapeutic Areas. Before moving to Licensing in 1998, for a considerable number of years, Alan led a Drug Metabolism/Pharmacokinetics Unit at ICI/Zeneca Pharmaceuticals and contributed to the development and registration of a number of successful drugs in addition to providing support to Research and Commercial groups across a range of therapeutic areas. Prior to joining ICI, he had previous experience in the Drug Metabolism department of Hoechst UK and as head of the Drug Metabolism section at Sterling-Winthrop.
His academic background is in Drug Metabolism, with a PhD from Birmingham University and a BSc in Chemistry and Biochemistry from St Andrews.
He is a well-recognized conference speaker and trainer, presenting on various aspects of Partnering and Due Diligence at a range of international conferences and workshops.
Warrander Consulting has very wide connections across the industry on a global basis and associations with an extensive network of consultants covering virtually every aspect of drug discovery, development, registration, business development and commercialization.
ONCY Appoints Senior VP, Global Licensing and Business Development
CALGARY, Dec. 11 /PRNewswire-FirstCall/ -- Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced the appointment of Dr. Alan Warrander to the role of Senior Vice President, Global Licensing and Business Development
"Dr. Warrander will be responsible for the execution of the global licensing strategy for REOLYSIN(R)," said Dr. Brad Thompson, President and CEO of Oncolytics. "Having reached an agreement on the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers with the U.S. Food and Drug Administration under the Special Protocol Assessment (SPA) process, and with ongoing Phase 2 studies in multiple indications, we felt it was important to bring this skill set in house."
In his 32-year career, Dr. Warrander has held a number of positions within the biotechnology and pharmaceutical industries. He held a number of progressively senior positions in the pharmaceutical industry, most recently as Director, Global Licensing, AstraZeneca. Dr. Warrander subsequently served as Senior Vice President, Life Sciences at Wood Mackenzie, providing partnering support and advice to a range of clients on licensing, merger and acquisition and financing projects globally. Most recently, as an independent consultant, he has worked with a number of biotechnology clients including Oncolytics, serving as a director of Oncolytics Biotech (Barbados) Inc. He holds a PhD from the Department of Biochemistry at the University of Birmingham and a BSc in Chemistry and Biochemistry from the University of St. Andrews
Exercise of Underwriters' Over-Allotment Option completed
The Company announced today that in connection with its previously announced unit offering, the underwriters have exercised in full their over-allotment option and purchased an additional 637,500 units. Each unit is comprised of one common share and 0.4 of a common share purchase warrant, and was sold at a price of US$3.00 per unit. Each whole common share purchase warrant entitles the holder to acquire one common share of Oncolytics upon payment of US$3.50 for a five year period ending November 23, 2014, subject to an acceleration of the expiry date in certain circumstances.
...
"Completing this financing further strengthens our balance sheet and will allow us to proceed beyond the 80 patient first stage of enrollment in our Phase III clinical trial, while giving us improved flexibility in reviewing partnering options," said Dr. Brad Thompson, President and CEO of Oncolytics. "After giving effect to this financing, we have in excess of $36 million in cash on hand."
Hello to the board as a new poster
Interesting you are talking about a company using a disabled HIV virus as a carrier to deliver gene therapy is a very exciting and "Virotherapy" is really starting to get some mainstream attention as a way to treat many forms of cancer as well.
My favorite company to talk about is Oncolytics Biotech a small company out of Calgary trading on the Nas as ONCY. Their main product candidate is a relatively harmless virus called the Reovirus which directly and selectively kills cancer cells while normal non cancerous cells fight off the virus and kill it within the cell. This is fascinating science in my mind and changes our collective notions that all viruses are harmful.
The ONCY investor presentation was just updated Nov 4th
http://www.oncolyticsbiotech.com/General_IR_talk_Nov4_2009.pdf
**** Check out the pictures (unless you are squeemish) on page 6
ONCY has been in development of their product for almost 10 years now and is near the finish line just entering the pivotal phase which will allow requesting approval having already agreed with FDA on a SPA. Most of the patients they are treating are patients who have failed the normal course of options already, referred to as refractory.
I recently contacted Ken to run his seasonality analysis on ONCY and found some interesting insights into the "seasonal" trading of Biotech stocks after seeing these results. You can view them on the ONCY iHub board if you want at
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=43214940
I have been a long investor of this company for 6 years now and have a long position now.
Hello to all.
onco_investor
Thanks for posting the analysis Ken
and the visit.
I have always wanted to see stock price data organized like this. Very many thanks and you can believe I will be looking more into your analysis style.
Biotech price movement usually follows formal clinical data release which for major events such as ASCO and AACR you can see year by year, month by month the price action going into and coming out of these as trend changing points. It is very interesting to also see the very bad months historically no matter what year. June-July and November are by far the worst on average!
There are several near term November events I am hoping will change that past trend ... at least this year.
Great work and thanks again.
onco_investor
Oncolytics to Present at BIO Investor Forum 2009
Webcast link for this presentation is listed below...
Presentation starts at 3PM PT, 6PM ET/5PM Central TODAY and is webcast.
CALGARY, Oct. 23 /PRNewswire-FirstCall/ - Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview of the Company at the 8th Annual BIO Investor Forum 2009 on Wednesday, October 28, 2009 at 3:00 p.m. PT. The conference will be held at the Palace Hotel in San Francisco on October 28 and 29, 2009.
A live audio link to the webcast presentation is available at:
http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=ONC.TO&item_id=2478360
or on the company's website at www.oncolyticsbiotech.com. It is recommended that listeners log on 15 minutes in advance of the presentation to register and download any necessary software.
An audio replay will be accessible approximately one hour following the presentation on the Oncolytics website.
About BIO Investor Forum
BIO Investor Forum is a national investor forum to explore investment trends and opportunities in life sciences, with a focus on public and venture-stage growth companies as well as those poised to join the growth "watch list" in 2010.
About Oncolytics Biotech Inc.
--------------------------------------------------------------
My personal opinion is that ONCY is using these venues to go talk to their potential partners in their neighborhoods, in this case Genentech who makes Avastin. Avastin has been noted as a potential adjunct for ONCY's Reovirus.
onco_investor
Reovirus mention in PharmaAsia article on Virotherapy
<< Small Australian company Viralytics was given prominent mention. No real discussion about the regulatory hurdles for an engineered virus but a very good article IMO. comments added >>
http://www.pharmaasia.com/article-7898-oncolyticvirotherapyofcancer-Asia.html
Oncolytic Virotherapy of Cancer
Erin Haley and Darren Shafren, University of Newcastle, and Viralytics
Modern day studies reveal that oncolytic viruses may be an effective therapy for dealing with cancer tumors.
Published Saturday, August 01, 2009
selected highlights...
Current Clinical Evaluation of Oncolytic Viruses
The genetic modifications and pre-clinical studies of oncolytic viruses outlined above have enabled the initiation of the clinical evaluation of an array of oncolytic viruses throughout the world. There are currently more than 10 different oncolytic viruses in various Phase I and II clinical evaluation studies. Comprising this panel of oncolytic viruses are both naturally occurring and genetically altered viruses, with routes of viral delivery including single/multiintravenous and intra-lesional injections.
In some clinical evaluation programs, oncolytic viruses are administered in combination with standard chemotherapeutic regimes and immune-suppressive agents. The tolerance profiles of cancer patients to oncolytic virotherapy are quite impressive when compared to those of cyto-toxic chemotherapeutics and some targeted monoclonal antibody therapies - with toxicity being limited to reports of "flu-like" symptoms following viral administration. The lack of statistical significant data from randomized clinical trials of oncolytic viruses against standard care agents, has historically cast a shadow as to the clinical future of this biologically targeted therapy.
In this environment however, two oncolytic virus companies, BioVex and Oncolytics Biotech have recently announced that they are undertaking pivotal randomized Phase III clinical trials with their lead candidates in late stage melanoma (OncoVexGM-CSF) and refractory head and neck cancers (Reolysin), respectively. Favorable outcomes from these trials should establish oncolytic virotherapy as an accepted targeted anti-cancer therapy, open the regulatory door for further pivotal oncolytic virus trials and finally, attract interest from pharmaceutical companies.
--------------------------------------------------
More widespread independent exposure is going to pay dividends at some point IMO.
Improving the Efficacy of Oncolytic Viruses?
Targeting the Tumour Vaculature to Improve the Efficacy of Oncolytic Virus
Preclinical research was published on this in the Journal of the National Cancer Institute published on November 27, 2007
http://jnci.oxfordjournals.org/cgi/reprint/99/23/1739.pdf
Jung Hyo Rhim
Giovanna Tosato
Credit to Bridger48 for uncovering this potential link to today's investment news.
Oncolytics Announces Investment in Private Biotech
http://finance.yahoo.com/news/Oncolytics-BiotechR-Inc-prnews-3318716701.html?x=0&.v=12
Press Release
Source: Oncolytics Biotech Inc.
On 6:00 pm EDT, Tuesday October 20, 2009
CALGARY, Oct. 20 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY) ("Oncolytics") announced today that it has made an investment in British Canadian Biosciences Corp. (BCBC), a privately held biotechnology company specializing in the development of peptides for the treatment of a variety of conditions, including cancer.
Oncolytics has purchased all of the convertible preferred shares of BCBC in exchange for 200,000 common shares of Oncolytics. If converted to common shares, Oncolytics would own 10% of the outstanding BCBC common shares. In addition, Oncolytics has obtained a right, under certain circumstances, to purchase the rights to BCBC's oncology product which is entering Phase II studies for use in solid tumours. The purpose of the transaction is to gain access, at a future date, to a potential new oncology product. Beyond this transaction, Oncolytics has no commitments for future program support to BCBC. None of the directors, officers, or related parties of Oncolytic's own shares in or have any commercial interests in BCBC.
-----------------------
Interesting YouTube on the MOA of this class of drugs in development.
CTRC in SanAntonio Starts Two Phase II Trials
Updated clinicaltrials.gov entry lists two new Phase II clinical trials using Reolysin in combo with chemo.
http://clinicaltrials.gov/ct2/results?term=reovirus
----------------------------------------------------------
REO 017 A Study of REOLYSIN® in Combination With Gemcitabine in Patients With Advanced Pancreatic Adenocarcinoma
http://clinicaltrials.gov/ct2/show/NCT00998322?term=reovirus&rank=9
Further study details as provided by Oncolytics Biotech:
Primary Outcome Measures:
Determine the clinical benefit rate (Complete Response (CR) + Partial Response (PR) + Stable Disease (SD))in the study population [ Time Frame: 6-9 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Evaluate the safety and tolerability of the treatment regimen in the study population as measured by adverse events associated with the study treatment, and defined by established criteria. [ Time Frame: Within 30 days of last dose of REOLYSIN ] [ Designated as safety issue: Yes ]
Determine the progression-free survival of this combination in patients with advanced or metastatic pancreatic adenocarcinoma. [ Time Frame: 9-12 months ] [ Designated as safety issue: No ]
Estimated Enrollment: 33
Study Start Date: October 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
Biological: REOLYSIN
1E10 TCID50, 1-hour intravenous infusion on Days 1 and 2 and then Days 8 and 9.
Drug: Gemcitabine
800 mg/m2 60-min infusion on Days 1 and 8.
Detailed Description:
Pancreatic cancer remains one of the most lethal cancers, ranking as the fourth leading cause of cancer death for both men and women. The American Cancer Society estimates that 37,170 men and women (18,830 men and 18,340 women) will be diagnosed with pancreatic cancer and 33,370 men and women will die of pancreatic cancer in 2008.
Activating KRAS mutations are the most frequent genetic abnormalities in pancreatic cancer (occurring in 75% to 95% of patients).
REOLYSIN has been demonstrated to kill a wide variety of cells with mutations along the RAS pathway, including pancreatic cancer cells.
The Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given intravenously in combination with gemcitabine every 3 weeks in patients with advanced pancreatic cancer.
Response is a primary endpoint of this trial. Tumors will be evaluated by CT scan within 14 days of starting treatment, then at 6 weeks, and then every 6 weeks thereafter.
The safety of the gemcitabine and REOLYSIN combination will be assessed by the evaluation of the type, frequency and severity of adverse events, changes in clinical laboratory tests, immunogenicity and physical examination.
Patients may continue to receive therapy under this protocol, provided he/she has not experienced either progressive disease or unacceptable drug-related toxicity that does not respond to either supportive care or dose reduction.
----------------------------------------------------
REO 021 A Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Squamous Cell Carcinoma of the Lung
http://clinicaltrials.gov/ct2/show/NCT00998192?term=reovirus&rank=6
Further study details as provided by Oncolytics Biotech:
Primary Outcome Measures:
Objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population [Time Frame: 6 months] [Designated as safety issue: No]
Secondary Outcome Measures:
Evaluate the safety and tolerability of the treatment regimen in the study population as measured by adverse events associated with the study treatment, and defined by established criteria. [ Time Frame: Within 30 days of last dose of REOLYSIN ] [ Designated as safety issue: Yes]
To assess progression-free survival (PFS) for the treatment regimen in the study population. [ Time Frame: 9-12 months ] [ Designated as safety issue: No]
Determine the proportion of patient receiving the treatment who are alive and free of disease progression at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No]
To determine overall survival with the treatment regimen in the study population [ Time Frame: 9-12 months ] [ Designated as safety issue: No]
Estimated Enrollment: 55
Study Start Date: October 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
Biological: REOLYSIN
3E10 TCID50 1 hour intravenous infusion, administered on Days 1,2,3,4,and 5 of a 21-day cycle
Drug: Paclitaxel
6 AUC mg/mL min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle
Drug: Carboplatin
200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle
--------------------------------------------------------------
Both trials are classified as actively recruiting as of today and both trials are sponsored by the CTRC in SanAntonio with Oncolytics providing the Reolysin.
So now with these 2 new trials we have 9 active Phase II trials:
KRAS+ Screened NSCLC (IV combo) - REO 016 at Ohio State Univ - (Interim data due next month?)
http://clinicaltrials.gov/ct2/show/NCT00861627?term=reovirus&rank=1
Platimun Refractory Ovarian (Monotherapy IV and IP) - NCI Sponsored Trial OSU-07022 at Ohio State Univ
http://clinicaltrials.gov/ct2/show/NCT00602277?term=reovirus&rank=2 and
http://www.cancer.gov/clinicaltrials/OSU-07022
Metastatic Melanoma (Monotherapy- IV) - NCI Sponsored Trial Enrolling at 7 Locations in the Mayo Clinic Cancer Centers trial network
http://clinicaltrials.gov/ct2/show/NCT00651157?term=reovirus&rank=4
Recurrent Malignant Glioma - REO 007 Monotherapy - Target end date moved to March 2010 for this long trial
http://clinicaltrials.gov/ct2/show/NCT00528684?term=reovirus&rank=5
Platinum Refractory Head and Neck Cancer - REO 015 Combo with Carboplatin and Paclitaxel - Waiting for Interim and Final Results (next month?)
http://clinicaltrials.gov/ct2/show/NCT00753038?term=reovirus&rank=7
Metastatic Melanoma - REO 020 Combo with Carboplatin and Paclitaxel - Just started enrolling a few months ago
http://clinicaltrials.gov/ct2/show/NCT00984464?term=reovirus&rank=8
--------------------------------------
Bone and Soft Tissue Sarcomas REO 014 (Has completed enrollment now awaiting final results.... Rumored to proceed to Phase II in combination with chemo or maybe an adaptive Phase II/III?
http://clinicaltrials.gov/ct2/show/NCT00503295?term=reovirus&rank=3
IMO lots to look forward to these next few months...
onco_investor
Global Calgary TV Segment on Oncolytics
http://www.globaltvcalgary.com/video/index.html?releasePID=rjclz2lRfgO2AYyeUJQqUlG9QYJD8Lsv
Great piece of work, the exposure is increasing from the recent SPA agreement with FDA.
Brad Thompson interviewed for the Health FYI segment dated today.
Market cap at a paltry $164 Mil right now. IMO get em while you can under $4. I just upped my position today by over 4k shares averaging $3.23 after yesterday's 6% fall. We gained most of it back later today and closed at the HOD. Seems people want to be in this stock over the weekends.
I'm waiting for Phase II results to be announced for H&N. Hopefully this and the next SPA submission will bring us back to $5 which will draw a much larger institutional shareholder base.
There is so much clinical trial data due to be published during the next 1-6 months that will really drive this stock IMO up or down. After so long being invested in this company it seems to me we are on the verge of the big time.
Do your own DD. For discussion only.
onco_investor
Homebrewing Tips
Bottling is the problem low, keep the beer in a 5 gal pressurized (with CO2) soda syrup container in a fridge with a portable tapper and you avoid all that hassle of bottling and being pressurized with CO2 you dont get spoilage.
Im getting ready to brew a batch of Honey Wheat Ale for a Thanksgiving party Im throwing.
onco_investor
Capitalism: A Possible Sea Change
By Jordan DiPietro ... The Motley Fool
An interesting take on today's state of affairs in the journalistic assault on capitalism.
http://www.fool.com/investing/general/2009/10/16/capitalism-a-possible-sea-change.aspx
Hey low, your welcome to join me on the ONCY board. I am now an assistant mod there. Stop by and see the latest news.
onco_investor
Five Red Flags to Watch Out For in a Biotech
From Dendreon Co-Founder Chris Henney
Luke Timmerman 10/15/09
Yesterday, we provided a rundown of the six hallmarks of a successful biotech company, according to Christopher Henney, the biotech pioneer who co-founded three of Seattle’s top biotechs—Immunex, Icos, and Dendreon. He made his remarks to an audience of about 100 investing professionals at the CFA Society meeting on Oct. 8 in Seattle.
Today, we follow up with the five red flags Henney advised investors to watch for when they evaluate biotech investments. Here’s what he singled out as warning signs:
—Top management without a scientific background. It’s not impossible for a biotech to succeed with a non-scientist at the helm, Henney said, but a smart investor must ask this non-scientific manager where the science comes from at the company. “The good answer would be, ‘It comes from my team of wonderful scientists who I recruited.’” A bad answer would be something like, “It comes from my scientific advisory board, which has two Nobel Laureates.” Henney added, “If you need to make an appointment to meet the guy who’s bringing you your science, then you don’t have much of a business.”
Henney wanted to make sure he wasn’t making a broadside attack against all non-scientific managers. One of his favorite biotech CEOs isn’t a scientist, but he adds, “You wouldn’t know it from talking to him.”
—No worries. An investor should ask what the management loses sleep over. “If they say, ‘I sleep like a baby,’ that’s a big red flag,” Henney said. All companies have their problems, and top management had better know them inside out.
—Hard-to-understand science. Ask the management to explain the science of their product in detail. “If they say something like the science is hard to explain, they can’t really explain it to you, that’s a big red flag.”
—Geographic remoteness. This provides some insight into Henney’s thinking on why two of the companies for whom he serves as chairman—Oncothyreon and AVI Biopharma—recently moved their headquarters from Edmonton, Canada, and Portland, OR, respectively, to the Seattle area. “You need a quorum of players,” Henney said. “You need access to talent, you need to be able to recruit people.” Seattle has more talent than the other places, and an ability to recruit more people, he said.
—Too many VCs. The board should be loaded with people that have experience running companies. “You shouldn’t have a board full of venture capitalists,” Henney said.
—Family members in key roles. “These aren’t family businesses. If you see a board dominated by siblings, or a couple of siblings in key management roles, I’d run, not walk.”
While those things might scare people away, Henney was hoping to drive home the message that investing in biotech actually isn’t that dangerous—if people know the right questions to ask. Despite the industry’s tough odds, he says he knows of people who make money in biotech year in and year out. He may have already been preaching to quite a few of the converted—I saw more than a few familiar biotech investors in the room—but Henney was hoping to light a spark for at least a few money managers to try their hand at something new.
“It’s a space that I wish more people would look at as an investment opportunity,” Henney said. “It can be really rewarding, and a lot of fun.”
Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com, call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman.
Six Tips on How to Spot a Winning Biotech
From Dendreon Co-Founder Chris Henney
by Luke Timmerman 10/14/09
http://www.xconomy.com/seattle/2009/10/14/six-tips-on-how-to-spot-a-winning-biotech-from-dendreon-co-founder-chris-henney/
—Solid Patents. All good biotech companies must have terrific science, and they must have patents to protect it, Henney says. In the industry’s early days, there weren’t many patent attorneys that knew what they were doing, but now there are plenty, he says. An investor ought to ask “how does the science stack up” at a company versus its competitors.
—The science should be focused on an important disease, with potential for breakthroughs. Lots of scientists will argue about what’s important and what’s not, but what an investor needs to know is that a biotech company is at the front of the pack. Immunex focused on an important disease, rheumatoid arthritis, and clearly made a breakthough. “You don’t want to be in fourth or fifth place” with a new drug, he says.
—Great management. This is a must in all industries, but it can’t be overstated in biotech. Interestingly, Henney has noticed some unusual character traits about biotech managers that he says shouldn’t scare off investors. “Like you see in software, these are managers who don’t walk into a room and dominate it. They are often fairly nerdy. But we’re talking about people who are smart, efficient managers,” Henney said.
—Access to capital. A company has to be able to prove it can raise money. Again, and again, and again. “Not many biotech companies go out of business because they lack ideas,” Henney said.
—Luck. “You need it. I’m fortunate to say Lady Luck visited me on many occasions,” Henney said. (I’m not sure how investors are supposed to be able to gauge whether a company has luck on its side, though.)
—Flexible attitudes toward human resources. This might sound nutty to straight-laced business school types, but biotech companies need to give breathing room to some brilliant, creative people who aren’t closely directed by management, Henney said. This can work for a small percentage of the top performers, like some of the brightest people at the National Institutes of Health. The most famous case of this in biotech, which Henney didn’t mention, came from Genentech scientist Napoleone Ferrara, who made discoveries in 1989 on his undirected time that gave birth to the breakthrough cancer drug bevacizumab (Avastin).
“You’ve got to let people follow their curiosity,” Henney said. “For some in the business community, that might sound like a sketchy proposition, but you have to.”
Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at ltimmerman@xconomy.com, call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman.
--------------------------------------
....more in next post
SAFC Pharma Completes Contract Manufacturing Facility Expansion
SAFC Pharma is part of Sigma Aldridge Corp and is ONCY's current contract manufacturer for our reovirus "formulation"
-----------------------------------------------------------
http://finance.yahoo.com/news/SAFC-PharmaR-Announces-prnews-4251634149.html?x=0&.v=1
SAFC Pharma(R) Announces Completion of $12M Contract Manufacturing Facility Expansion in Carlsbad, Calif.
Addition Enhances Capabilities and Capacity Bolsters Biologics and Viral Manufacturing; Reinforces Support for Secure, Successful Customer Launches
Press Release
Source: Sigma-Aldrich
On 1:00 am EDT, Tuesday October 13, 2009
Buzz up! 0
Print
Companies: Sigma-Aldrich Corporation
ST. LOUIS, Oct. 13 /PRNewswire-FirstCall/ -- SAFC Pharma®, a business segment of SAFC®, a member of the Sigma-Aldrich® Group (Nasdaq: SIAL - News), today announced the completion of an addition to its Carlsbad, Calif., facility that expands the Company's contract manufacturing services for its late phase and commercial clients. The $12 million project includes the addition of two fully segregated state-of-the-art viral product manufacturing suites, built to employ the latest in disposable bioreactor technologies, expanding SAFC Pharma's biologics, viral vaccines and gene therapy manufacturing to commercial-scale quantities.
SAFC Pharma's Carlsbad site specializes in the process development and manufacturing of viral vaccines and viral therapeutics, including a full menu of support services, from preclinical process and analytical development to final fill/finish and commercial bulk drug supplies. The new expansion, designed for multi-lot campaigns, includes dedicated cell expansion, bioreactor production, purification and cleanroom suites. Adding 8,000 sq. ft. of manufacturing space to the existing 44,000 sq. ft. site, the addition enables both 100-liter batch production in stirred tank bioreactors and 1,000-liter batch manufacturing in disposable bioreactors, and is Biosafety Level 2 compliant, allowing manipulation of human pathogens. Designed from the outset as a containment facility, the expansion space allows clients to secure a dedicated suite of cleanrooms for larger scale manufacturing.
"We are delighted to announce this expansion of our capabilities at our Carlsbad facility, particularly when the economic environment has been so challenging," commented David Feldker, Vice President SAFC Pharma. "We expect to see a great deal of value in the biologics and viral manufacturing marketplace in the next three to five years generated by two main customer types - those with late clinical phase opportunities but without any in-house manufacturing capability and those with late clinical phase opportunities that have some manufacturing capabilities but may be seeking an additional 'safety net' or wish to avoid additional capital expansion until their technology and drug has proven itself. By adding and extending our capabilities at Carlsbad, we are providing customers with an attractive, clear pathway that adds value and supports secure, successful product launches."
"The expansion at our Carlsbad campus underlines SAFC's strategy to continue to invest in building world class capabilities that serve and enhance our leadership in important emerging new technologies such as niche biologics production and viral manufacturing - areas where we see great potential and traction," added SAFC President Gilles Cottier. "Our investment in large capacity manufacturing, our financial stability, experience and quality systems differentiates us in the market and enhances our abilities to securely support our customers all the way to successful product launch."
Facility validation studies are currently underway, with an expected start of cGMP manufacturing operations by the end of December 2009. The site added numerous utility support systems to allow for continuous operation and will now utilize its new Water For Injection (WFI) system. The Company has enjoyed a close relationship with a number of clients developing an exciting array of cancer therapeutics, gene therapies and mammalian and insect cell-based viral vaccines.
SAFC has announced worldwide investments totalling $90 million in the past two years to expand capacity for active pharmaceutical ingredients (API) production and biologic drug products. These investments build on the Company's strengths in complex emerging technologies such as high potency manufacturing and viral vaccines manufacturing, further expanding its capabilities to serve customers in these growing areas. The expansion in Carlsbad follows the acquisition in 2007 of Molecular Medicine BioServices, Inc.
About SAFC®: SAFC is the custom manufacturing and services group within Sigma-Aldrich that focuses on high-purity inorganics for high technology applications, cell culture products and services for biopharmaceutical manufacturing, biochemical production and the manufacturing of complex, multi-step organic synthesis of APIs and key intermediates. SAFC has manufacturing facilities around the world dedicated to providing manufacturing services for companies requiring a reliable partner to produce their custom manufactured materials. SAFC has four focus areas - SAFC Pharma®, SAFC Supply Solutions®, SAFC Biosciences®, and SAFC Hitech® - and had annual sales of over $600 million in 2008. SAFC is one of the world's 10 largest fine chemical businesses. For more information about SAFC, visit www.safcglobal.com.
About SAFC Pharma®: SAFC Pharma is a complete pipeline partner for the development and cGMP custom manufacturing of complex small-molecule APIs and biologic drug products. It combines world-class project management and chemistry support for all stages of the drug discovery and development process from research and discovery, through pre-clinical and clinical development to commercialization, with a focus on reducing the drug development time-line. SAFC has the widest range of raw materials, highly qualified and experienced staff, state-of-the-art facilities and an integrated portfolio of services, including full analytical and regulatory support and is a leader in emerging technologies, including high-potency APIs, solid-state chemistry, viral products and chemical-biologic API conjugates. For more information visit www.safcpharma.com.
------------------------------------------------------------
onco_investor
IRG Podcast - Dr Brad Thompson Interview
More Ph III SPAs on the way??
http://irgnews.com/podcast/episode22
Highlights for me...
The US phase II H&N trial is almost finished..."With the REOLYSIN/chemo combination treatment we are seeing a 40% response rate, which is 5-10 times the response rate one expects to see in this patient group. Progression free survival is at least 3 times what one expects to see in this patient group." <<It fits that positive maybe very positive data should be announced soon>>
Phase III SPA is double blinded, Part A is 80 patients and allows unblinding the data. And data to be available in "one year, plus or minus a quarter"
Already writing several other SPA protocols. One will be submitted in 2009 and one in 2010. <<YES!>>
Worth a listen
onco_investor
REOLYSIN(R) Nearing The Big Hurdle - Chinook Traveler
http://seekingalpha.com/instablog/383010-chinook-traveler/30137-reolysin-r-nearing-the-big-hurdle
Repost from Seeking Alpha
Although Oncolytics Biotech’s REOLYSIN(R) has not shown itself to be a “silver bullet” that many cancer researchers have been searching for, if it eventually gains approval by the U.S. Food and Drug Administration (FDA), it likely will succeed in proving to be a first in class, and best in class cancer treatment for the majority of cancers until a superior treatment is developed. In my opinion, it will provide valuable time for very ill cancer patients, time to hopefully stabilized their disease similar to what has occurred in the treatment of HIV, which originally was thought of as a “death sentence” for those infected. REOLYSIN(R) is not yet been approved for use by the FDA but is about to face the crucial hurdle, a Phase III trial.
Dr. Brad Thompson CEO and President of Oncolytics, in a conference call Friday, announced that the company and the FDA have reached an agreement on their planned pivotal Phase III Clinical Trial. Under the Special Protocol Assessment (SPA) process for the trial design, the randomized, two-arm, double-blinded , two stage, adaptive trial will treat patients with platinum-refractory head and neck cancers. Treatment will consist of a combination of intravenously administered REOLYSIN(R) with placitaxel and carboplatin, or for the control arm the same chemo agents without REOLYSIN(R). This upcoming trial is based on the results of their Phase I/II trial treating similar cancers wherein the clinical response benefit rate (complete response + partial response + stable disease) was 75% and many fold improvement over historical results with just chemo agents. Patients enrolled in this planned trial must have failed previous platinum agent chemotherapy and had their cancers reoccur or metastasize. If Oncolytics achieves the agreed endpoints, the primary one being overall survival (OS), followed by progression free survival (PFS), or objective response rate (CR + PR + duration of response), and safety, as well as tolerability, then approval for this unique therapy will be sought and should be approved.
When I wrote an article for Seeking Alpha, last March 23, Oncloytics (ONCY) was trading at $1.31/share and Friday traded as high as $3.80 before settling back to close at $3.54/share a 20.4 % gain over the Thursday closing price of $2.94. Since the March article, Oncolytics has continued with other Phase II trials and Dr. Thompson advised that they will continue exploring therapeutic benefits of REOLYSIN(R) with other major types of cancers that are known to have activate RAS signaling pathways. Patients in late stage major types of cancer are being treated with reovirus to determine efficacy of treatment. For example, on September 24, Oncolytics announced that the Cancer Therapy & Research Center at the University of Texas Health Science Center (CTRC) has started enrolment in a U.S. Phase II clinical trial using intravenous administration of REOLYSIN(R) in combination with paclitaxel and carboplatin in patients with metastic melanoma. Previous trials with melanoma patients using local administration of REOLYSIN(R) in combination with radiation or chemotherapeutic agents, resulted in nearly all the patients exhibiting at least stabilization in their disease. Previous preclinical data has conclusively demonstrated synergism when REOLYISN(R) is given in combination with various chemotherapeutic agents as well as co-treatment with radiation. It has also demonstrated efficacy as a monotherapy by selectively killing malignant cells while sparing normal ones.
Since the majority of metastatic cancers have an activated RAS pathway, therapies utilizing REOLYSIN(R) would appear to be logical part of any cancer therapy to halt the major problem when fighting this disease, metastasis. Preclinical experiments, as well as human clinical trials, have shown reduction or destruction of metastatic cells and tumors by circulating reovirus. One unique property of REOLYSIN(R) administration compared to currently approved cancer therapies, is the minimal side effects which are similar to a mild virus infection. To date, no maximum tolerated dose (MTD) has been reached. More compelling is the synergism exhibited by REOLYSIN(R) when combined with a number of chemotherapeutic agents or radiation which have clearly shown significant synergistic therapeutic results for patients with advanced disease, patients for whom there are limited or few options. To date, ten human clinical trails have been concluded, all with promising results attesting to the ability of this reovirus to infect and lytically destroy cancer cells while avoiding harm to normal cells. In addition to directly lysing cancer cells, by co-opting these cells to produce progeny virus particles resulting in bursting of the cell’s membrane. There is some evidence that cellular immunity against the cancer cells may be enhanced or activated, to assist in tumor destruction.
Oncolytics has also validated production of a 100 liter batch of reovirus as well as lyophilization of their product that is being used for current and planned trials.
On September 1, Oncolytics announced it was granted its 32nd U.S. Patent entitled “Viruses for the Treatment of Cellular Proliferative Disorders” which secured previous U.S. patents covering the use of other oncolytic viruses to treat RAS-mediated cancers (such as modified parapoxivirus, adenoviruses and mutated herpes simplex virus). Thus, it has a strong patent position regarding their product or future products in this area.It is gratifying for long term investors in this company, and more importantly, those on the front line treating ill cancer patients, that have been following their deliberate and focused efforts to produce a therapy, to observe this step in their attempt to seek authorization for sale of their prospective product. For investors, the increase in share price of their stock, relative to the potential of this unique treatment hopefully represents the beginning of an anticipated increasing valuation as they proceed toward authorization and sale of product. Although it is possible that Oncolytics will not attain their desired goal for the above planned Phase III trial, in my opinion, it is more likely based on their previously published preclinical data and the results of concluded human clinical trials that they will be successful as stated in my above referenced article. Obviously if they are, the stock should ultimately reflect this truly unique approach to cancer therapy.
Within two years, long term investors, like myself, who have been patiently investing and waiting, will most likely know whether REOLYSIN(R) is truly the treatment that it appears it may be.
What current cancer treatment (agents or drugs) or therapies (or potential treatment or therapy) has shown promising results with the such vast number of cancers in such a synergistic fashion (with radiation and chemo drugs)? How many other treatments have not reached their maximum tolerated dose (MTD) or had such benign side effects while sparing normal cells? How many agents can overcome resistant cancers with the same drug after treatment with the experimental agent? How many agents or drugs can access all portions of the body to seek out and kill metastatic cells? If a seeking alpha reader knows of a similar or better company selling at the current price of under $4.00/share, please share it with other seeking alpha readers since I believe it would be a bargain.
The author is has no affiliation with Oncolytics and is LONG on ONCY.
TheScientist.com on Adaptave Trial Design
http://www.the-scientist.com/article/display/55856/
Adaptive Evolution
A once-rare type of clinical trial that violates one of the sacred tenets of trial design is taking off, but is it worth the risk?
Doriano Solinas
When researchers at Pfizer first began a Phase 2 trial of an acute stroke therapy in 2000, they decided to take a novel approach. The study—called the ASTIN trial—would determine the drug’s optimal dose not with three or four different dosing arms, as trials often have, but with 15. Data from the trial would be captured continuously and used to make changes in real time to how the trial was run. As new patients joined, they would be randomized to a particular arm based on those real-time results—a process which required an intensive level of relatively novel statistics.
Before the drug entered Phase 3, the data showed that it was ineffective, and the trial ended in 2001. But processing a massive amount of real-time data as the trial went on, rather than waiting to conduct the analysis after it ended, saved Pfizer about $3.5 million by the company’s estimates. “Pfizer dropped [the therapy] like a hot potato,” says Donald Berry, a biostatistician at the University of Texas M.D. Anderson Cancer Center in Houston.
Life in a "Rent-a-Lab"
ASTIN’s methodology, termed adaptive trial design, goes against the sacred rule of the randomized double-blind, placebo-controlled trial: In order to avoid influencing the trial’s outcome, no one should know who is getting which treatment.
But in an increasingly common approach, a trial can be altered in various ways while it’s still in progress, perhaps by tweaking the sample size, dropping ineffective dosing arms, or even changing the endpoint. Such modifications are based on a peek at interim data—which of necessity means unblinding the data before the trial’s completion.
“If you’re looking at trial data before it’s completed, there’s always the chance that you’re jeopardizing the trial’s integrity.” —Scott Evans, Harvard University
“The reasons to do it are pretty clear,” says Janet Wittes, president of the clinical trial design firm Statistics Collaborative, Inc., in Washington, DC. Adaptive trials “hold the potential and the promise for doing trials faster and getting answers faster.” Plus, assessing assumptions you made in planning a trial as it proceeds can strengthen a trial’s scientific merit, says Scott Evans, a biostatistician at Harvard University.
According to Berry, a vocal champion of adaptive design, “the randomized trial moved us up to a very high level in terms of science,” he says. “We’re trying to preserve that level but move to even higher levels in terms of efficiency.” Clinical trials, especially late-stage ones, can cost tens to hundreds of millions of dollars; done right, an adaptive design can shave 20–50% off that sum.
In the past few years, pharmaceutical companies have adopted the approach in full force. Many—such as Wyeth, Eli Lilly, and Novartis—have dedicated divisions for adaptive trial design. For biotechs with few resources, the possibility of a faster, cheaper clinical trial may be even more of a draw.
But like all propositions that sound too good to be true, there’s a downside. Too often, critics caution, companies wrongly assume the approach is an easy fix to common clinical trial woes when, in fact, the changes can ultimately cost time and money, not save them. “There’s been a lot of overselling, overmarketing, if you will,” says Bob O’Neil, who heads adaptive design efforts for drugs and biologics at the US Food and Drug Administration (FDA). “This is not a panacea for all situations,” he stresses. “It is not standard fare.”
There’s also a bigger concern, which has both US and European regulators struggling to delineate when the approach is appropriate and when it isn’t. Trials are traditionally blinded in order to prevent investigators’ or subjects’ knowledge from influencing the outcome. “If you’re looking at trial data before it’s completed, there’s always the chance that you’re jeopardizing the trial’s integrity,” Evans says.
By design
Adaptive design is a slippery term, and experts argue about its definition. Some adaptations are so straightforward that they raise no concerns whatsoever, Wittes explains. Stopping a trial early, for example, because the treatment works either much better or much worse than expected, is nothing new. Starting with a few concurrent dosing arms and, based on interim results, winnowing them down to the best one or two is also generally not controversial, she said, though the FDA would need to ensure that protocols were in place in such cases to prevent anyone but a data monitoring board from seeing the interim data.
Other adaptations, though, walk a finer line, and whether or not they’re okayed depends on the reasons for implementing them as much as on the adaptations themselves. Suppose, for example, that interim results show that the variance in the data is larger than you’d like. “Variance is a nuisance parameter,” says Wittes. “I don’t think anyone has any trouble” with the idea of increasing the trial’s size in this case. But say the treatment’s effect appears to be smaller than expected, contradicting the prediction for efficacy that the company filed with the FDA before commencing the trial. In that case, by increasing the trial size, she believes, “you’re really changing your hypothesis,” which is based on a prediction of how well the drug works.
Indeed, the FDA itself does not yet have a clear understanding of what this type of trial entails. “We want to put some definitions in place for what we mean as an adaptive design,” says O’Neil. To this end, the agency assembled a working group in 2004, but has yet to release its promised guidance document for companies to follow. Until then, the agency’s take on a particular company’s proposal may depend on who sits on its FDA panel. The European Medicines Evaluation Agency (EMEA) came out with a guidance document in October 2007, and is somewhat less conservative on some elements of the approach than the FDA. One example, explains Berry, is the way the two agencies treat seamless Phase 2/Phase 3 trials—while EMEA generally allows data from Phase 2 patients to be included in the Phase 3 trial, FDA is more cautious.
Even straightforward adaptations don’t come without challenges. For an adaptive dose range such as the now-defunct Cervelo Pharmaceuticals used in testing a drug for neuropathic pain, looking at interim data and modifying the doses was “quite a logistical nightmare,” says Marc de Somer, chief medical officer. Also, interim data must be evaluated by an independent data monitoring board, made up of people uninvolved in the study or the company. “It’s a tough pill for companies to swallow, putting decisions about a trial into the hands of totally independent bodies,” notes Bruce Turnbull, a biostatistician at Cornell University.
Still, the use of adaptive trials is definitely on the rise, though different experts offer varying estimates. A survey by Cytel—a biostatistical software company in Cambridge, Mass., which pioneered adaptive trial design—of trials conducted between 2003 and last year identified 59 companies that used the approach. “When we hit 2007, there was [something] like a step change—now people were really ready to try them,” said Judith Quinlan, a biostatistician at Cytel. Today, Berry guesses that more than one in 10 trials have some sort of interim data monitoring, while Stuart Pocock, a medical statistician at University College London, says the number of truly adaptive trials is significantly less than 1 in 10. (The approach is much more common in medical device trials.) Pocock notes that “nobody has the overall picture,” since trial details are generally kept confidential until it’s time to file with a regulatory body. According to O’Neil, about 40 or 50 drug trials using the approach have so far submitted filings for FDA approval.
Pitfalls and promise
Regardless of the adaptation, unblinding the data for an interim peek invariably brings up two problems for regulators. The first one is statistical in nature. Because statistics measure the likelihood, based on probability, that a treatment is effective, repeating a statistical test multiple times increases the chances that one test along the way will mistakenly show an effect where there actually is none, and companies will submit that false-positive data to the FDA. “If you’re always tweaking [the trial] to get the best result possible,” says Turnbull, “then you will get the best result possible.” There are statistical maneuvers to counteract that possibility, but they are far from straightforward, he explains.
The second concern is operational: When an adaptation to a trial takes place, will investigators and patients put two and two together to deduce clues about the therapy’s efficacy? “Let’s say we’re going to increase sample size, or drop certain arms,” Evans says. “Well, that adaptation could send a message to people involved in the trial that the effect isn’t what you’d expect it to be. If that then changes people’s actions—whether it be investigators or patients—then you’ve introduced a source of bias.”
“There are a lot of amateurs running around saying we should do this without understanding the statistics behind it.” —Bruce Turnbull, Cornell University
By and large, adaptations in early-stage trials are not problematic. In fact, says O’Neil, “we think they’ve been underexplored” in that context. But regulators need much more convincing in Phase 3, or in Phase 2 trials that propose to morph directly into Phase 3 without the 6–9 months of analysis between the two steps. Proposals that include such seamless Phase 2/3 trials undergo intense regulatory scrutiny, which can offset whatever time you’ve gained from the adaptation.
And at any stage, the approach requires “a lot more prospective planning, a lot more complexity in design, and perhaps even more risk, in terms of will [the trial] turn out as you had planned,” says O’Neil. Every possible eventuality in the trial that may result in an adaptation must be thought through and documented in advance—a simulation exercise requiring an enormous amount of statistical resources that small companies generally don’t have in-house. “There are a lot of amateurs running around saying we should do this without understanding the statistics behind it,” Turnbull notes.
Some say that the pressures of efficiency push some companies to misuse it. One strategy Wittes has encountered is undersizing trials in order to bait investors, she says. A company that can’t afford to run a full trial might plan an adaptive trial that stipulates an “outrageously large” effect for their treatment and contains a built-in plan to increase subject numbers if this noncredible effect size isn’t met. “Then at some planned interim they look at the data and they say, ‘Oh, the observed effect size is smaller than anticipated.’” Still, that limited data can be used to lure investors to fund the larger trial. “What I worry about is that in part [adaptive design] has caught on because of business pressures,” Evans says.
For Cervelo’s de Somer, conducting an adaptive trial meant hiring Cytel to help plan the trial and determine what, if any, adaptations were appropriate, at the cost of $200,000 for a $10 million trial. “I think it’s an investment of a few months and a few hundred thousand dollars for a trial that costs at least 50 to 100 times more,” de Somer says. “Beyond the money, it’s probably worth it from an ethical and a regulatory perspective.”
Indeed, if done right, the approach has one benefit that’s hard to deny: It forces trial organizers to plan their studies carefully, whether or not they decide to make adaptations. “I think the by-product [of attempts to implement adaptive trials] is an appreciation of much more prospective planning in trials than we had even five years ago,” says O’Neil. Quinlan agrees. “The process itself is really the benefit of adaptive design,” she says. “Whether or not you choose to have an adaptive design, if you go through the process of evaluation of comparing it with a traditional trial, you’ll end up with a better trial.”
---------------------------
IMO looks like ONCY scored big time with this SPA getting an 80 patient Part 1 trial could be completed very quickly.
onco_investor
Calgary Herald - Oncolytics soars on nod for trial
http://www.calgaryherald.com/health/Oncolytics+soars+trial/2061344/story.html
Oncolytics soars on nod for trial
Cancer treatment advances at U. S. drug regulator
BY LISA SCHMIDT, CALGARY HERALDOCTOBER 3, 2009COMMENTS (1)
Oncolytics Biotech Inc. marked a milestone Friday after getting the go-ahead from the U. S. Food and Drug Administration on its plan on late-stage trials for its cancer treatment.
The company said the research could eventually support a licence application submission for Reolysin, which uses a naturally occurring reovirus to target mostly solid-tumour cancers that have a tendency to spread, or metastasize, such as in head and neck tumours.
"It's a little bit daunting, and a little bit exciting to be the first," Brad Thompson, chief executive for Oncolytics, said in a conference call with analysts Friday.
The announcement sent shares of the Calgary-based biotechnology company soaring to their highest levels in three years. Oncolytics shares closed up 53 cents to $3.71 on the Toronto Stock Exchange on Friday. The stock rose as high as $4.10 a share in earlier trading.
The testing will look at the effectiveness of using the treatment in combination with regular chemotherapy.
"This (trial) provides an agreed upon path for product development from now until submission for product approval," Thompson said.
"It allows us to proceed into this Phase 3 trial with the confidence that if the trial is successful, we should be able to move forward toward product approval in the United States and also provide guidance toward the use of Reolysin in other cancer applications."
Oncolytics "is in active discussions" for a partner to help fund the next phase of research--which will cost about $15 million, or about $60,000 a patient. But Thompson said the company will likely proceed with the first stage of the trials, which will involve about 80 patients throughout the U. S., the U. K. and Europe. The second phase is expected to include between 100 and 400 patients.
For a drug to reach the market, it generally has to go through extensive research and testing on animals, then four phases of controlled clinical trials on humans. The third phase is considered the most important stage in any new drug's development.
Many trials stall before hitting this crucial stage, as results show treatments are ineffective or have adverse reactions, said one researcher.
"To get to this stage is actually already a big achievement," said Dr. Randy Johnston, a professor in cancer research at the University of Calgary's Faculty of Medicine.
"As far as I'm aware, it's the first new generation cancer therapy that uses this kind of virus . . . to get through to a Phase 3 trial."
Oncolytics started develop Reolysin a decade ago with research started at the University of Calgary.
Since then, Oncolytics has enrolled approximately 330 patients in clinical studies, gone public and recently partnered with the Cancer Therapy and Research Center at the University of Texas Health Sciences Center in San Antonio.
"We're very proud that a discovery that began here in Calgary is getting to this level," added Johnston.
lschmidt@theherald.canwest.com
© Copyright (c) The Calgary Herald
-------------------------------
onco_investor
BioWorld Today Headlines - Oncolytics in the news
http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=52272
Oncolytics' Phase III Borrows Adaptive Design in SPA Trial
By By Catherine Hollingsworth
Oncolytics Biotech Inc. reached agreement with the FDA on the design of a Phase III trial of Reolysin in head and neck cancer, marking the first such agreement for an intravenously administered oncolytic virus.
The Phase III trial will be conducted in two stages and will cost an estimated $15 million, Matt Coffey, Oncolytics' chief operating officer, told BioWorld Today. The Calgary, Alberta-based company has the cash to get through the first half of the study on its own, but it hopes to secure a partner to take Reolysin the rest of the way, he said.
The trial uses an adaptive design in which "the endpoint is not fixed going in," CEO Brad Thompson said during a conference call. He said it was "a major advantage" getting the FDA to sign off on the study design up front under a special protocol assessment.
Thompson said that the adaptive design already is in use in the area of infectious disease, and he said he believes that there will be "a big push" by the FDA for more adaptive trials to be conducted in oncology.
The trial will assess the intravenous administration of Reolysin with the chemotherapy combination of paclitaxel and carboplatin vs. chemotherapy alone. The drug likely will be studied in about 275 patients whose cancer has progressed while on or after prior platinum-based chemotherapy.
The first stage of the trial is nonadaptive and is designed to enroll 80 patients. The second stage is adaptive, and is designed to enroll between 100 and 400 patients with the most probable statistical enrollment being 195 patients.
According to Oncolytics, the Phase III adaptive trial allows frequent data evaluation to determine if the probability of reaching a statistically significant endpoint has been achieved.
The primary endpoint for the trial is overall survival, and secondary endpoints include progression-free survival, objective response rate (complete response plus partial response) and duration of response and safety and tolerability of Reolysin when administered in combination with paclitaxel and carboplatin.
The decision to pursue a Phase III trial in head and neck cancers was based on positive results seen in preclinical work and the company's UK Phase I and Phase II combination studies of Reolysin and paclitaxel/carboplatin. Interim results of the U.K. Phase I/II trial reported in March demonstrated an overall response rate of 42 percent and a total clinical benefit rate of 75 percent. Updated Phase II results are expected to be presented later this quarter.
First-in-class Reolysin, a proprietary formulation of the reovirus, could be "as significant as the introduction of the antibody therapy," Coffey said.
Reolysin is designed to replicate in cancer cells that have an activated RAS pathway, seen in about two-thirds of all cancers. Oncolytics sees an opening with Reolysin in metastatic cancers, including colorectal and non-small-cell lung cancers, and in patients with a mutated KRAS gene who are unlikely to respond to treatment with anti-EGFR monoclonal antibodies.
Under recent labeling revisions, the EGFR class of antibodies is not recommended in colorectal patients who have KRAS mutations in their tumors because they do not respond to EGFR-blocking antibodies.
Head and neck cancer is primarily treated with radiation and surgery and chemotherapy is typically used in advanced cases.
Oncolytics has several other ongoing clinical trials of Reolysin, including a Phase II study in NSCLC with K-RAS or EGFR-activated tumors.
Shares in Oncolytics (NASDAQ: ONCY) were up 60 cents or 20 percent, closing at $3.54.
Published October 5, 2009
-------------------------------
onco_investor
SPA Reached with FDA for Phase III Head and Neck
http://finance.yahoo.com/news/Oncolytics-BiotechR-Inc-prnews-2349689999.html?x=0&.v=2
First company to get an IV delivered viral therapy clinical trial approved.
Product approval pathway defined.
Conference call going on right now.
Oncolytics Biotech(R) Inc. Reaches Special Protocol Assessment Agreement with the FDA on Design of Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers
Press Release
Source: Oncolytics Biotech Inc.
On Friday October 2, 2009, 8:00 am EDT
CALGARY, Oct. 2 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the design of a Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The SPA is an agreement between Oncolytics and the FDA that the design and planned analyses of the Phase 3 study is adequately designed to provide the necessary data, that depending upon outcome, could support a license application submission for REOLYSIN.
"Oncolytics is the first company to reach an agreement with the FDA on a Phase 3 trial design for an intravenously-administered oncolytic virus under the SPA process," said Dr. Brad Thompson, President and CEO of Oncolytics. "This is an exciting step forward for our clinical program for REOLYSIN, which has become a first-in-class agent. A Phase 3 trial in patients with platinum-refractory head and neck cancers is a logical choice for our first pivotal trial with REOLYSIN. In Phase 1/2 trials, the treatment combination has increased the response rate by several-fold compared to historical outcomes."
As specified in the SPA, the randomized, two-arm, double-blind, multicentre, two-stage, adaptive Phase 3 trial will assess the intravenous administration of REOLYSIN with the chemotherapy combination of paclitaxel and carboplatin versus the chemotherapy alone in patients with metastatic or recurrent squamous cell carcinoma of the head and neck, or squamous cell cancer of the nasopharynx, who have progressed on or after prior platinum-based chemotherapy. All patients will receive treatment every three weeks (21 day cycles) with paclitaxel and carboplatin and will also receive, on a blinded basis, either intravenous placebo or intravenous REOLYSIN. All dosing takes place in the first five days of each cycle with all patients receiving standard intravenous doses of paclitaxel and carboplatin on day one only, and on days one through five, either intravenous placebo or intravenous REOLYSIN at a dose of 3x10(10) TCID(50). Patients may continue to receive the trial combination therapy for up to eight, 21-day cycles and, thereafter, blinded placebo or blinded REOLYSIN until the patient has progressive disease or meets other criteria for removal from the trial.
The primary endpoint for the trial is overall survival (OS); secondary endpoints include progression free survival (PFS), objective response rate (complete response (CR) + partial response (PR)) and duration of response, and safety and tolerability of REOLYSIN when administered in combination with paclitaxel and carboplatin. The first stage of the trial is non-adaptive, and is designed to enroll 80 patients. The second stage is adaptive, and is designed to enroll between 100 and 400 patients with the most probable statistical enrolment being 195 patients in this stage. This adaptive trial design allows frequent data evaluation to determine if the probability of reaching a statistically significant endpoint has been achieved.
The decision to pursue a Phase 3 trial in head and neck cancers was predicated on positive results seen in the Company's U.K. Phase 1 and Phase 2 combination REOLYSIN and paclitaxel/carboplatin clinical trials, as well as significant preclinical work demonstrating synergy in combination with taxane or platinum-based drugs. Interim results of the U.K. Phase 1/2 trial reported in March 2009 demonstrated an overall response rate (PR and CR) of 42% and a total clinical benefit rate (PR + CR + stable disease) of 75%. Enrolment in the Phase 2 portion of the trial was concluded in July 2009, and updated results are expected to be presented in the fourth quarter of 2009.
Conference Call Details
Dr. Brad Thompson, President and CEO of Oncolytics, will host a conference call and webcast today, October 2, 2009 at 6:30 a.m. MT (8:30 a.m. ET) to update investors on the Phase 3 program for REOLYSIN. To access the conference call by telephone, dial 1-416-644-3426 or 1-800-732-1073. A live audio webcast will also be available at the following link: http://www.newswire.ca/en/webcast/viewEvent.cgi?eventID=2828320 or through the Company's website at www.oncolyticsbiotech.com. Please connect at least 15 minutes prior to the webcast to ensure adequate time for any software download that may be needed. A replay of the webcast will be available at www.oncolyticsbiotech.com and will also be available by telephone through October 9, 2009. To access the telephone replay, dial 1-416-640-1917 or 1-877-289-8525 and enter reservation number 4169017 followed by the number sign.
About the Special Protocol Assessment Process
Upon the request of a study sponsor, the FDA will evaluate certain protocols and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements; this includes clinical protocols for Phase 3 trials whose data will form the primary basis for an efficacy claim that will be part of an original Biologics License Application. For more information about the SPA process, please go to:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080571.pdf
About REOLYSIN
REOLYSIN is a proprietary formulation of the human reovirus that acts primarily as a direct cytotoxic agent. Reovirus is naturally occurring (not genetically engineered) and has been demonstrated to replicate specifically in tumour cells bearing an activated Ras pathway, leaving healthy normal cells intact. At least two thirds of carcinomas and more than 90% of metastatic disease has Ras involvement.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics' clinical program includes a variety of human trials including a Phase III trial in head and neck cancers using REOLYSIN, its proprietary formulation of the human reovirus. For further information about Oncolytics, please visit: www.oncolyticsbiotech.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including the Company's expectations related to the SPA agreement on a Phase 3 combination REOLYSIN and paclitaxel/carboplatin trial for patients with platinum-refractory head and neck cancers, the planned timing and implementation of the Phase 3 trial, and the Company's belief as to the potential of REOLYSIN as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the tolerability of REOLYSIN outside a controlled test, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN, uncertainties related to the research and development of pharmaceuticals and uncertainties related to the regulatory process. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward-looking statements. The Company does not undertake to update these forward-looking statements, except as required by applicable laws.
Oct 11-14 BioPartnering Europe and China
http://www.reuters.com/article/pressRelease/idUS105626+24-Sep-2009+BW20090924
The Top Fifteen Global Pharmaceutical Companies to Attend BPE this Year!
LONDON--(Business Wire)--
Technology Vision Group (TVG) is pleased to announce details of the program for the 17th Annual BioPartnering Europe (BPE) and BioPartnering China (BPC)conference in London from 11-14 October 2009, providing four days of networking in one location. BPE`s continued popularity is due to the innovative and informative program which annually addresses the latest trends affecting the
biotech industry today. This year, the conference is not only offering an exciting and interesting range of leadership sessions, workshops and presentations at BPE but also the chance for delegates to further their knowledge of the exciting Chinese market at an extra one-day event, BPC.
Conference Sponsors
Premium
AstraZeneca
Platinum
Deloitte
Gold
Cooley Godward Kronish LLP; Goodwin Procter LLP; Ferghana Partners Group; Taylor
Wessing LLP
Silver
Amgen; Bristol-Myers Squibb Company; GlaxoSmithKline; Merck & Co.; Novartis;
Perkins Coie; Pfizer Inc; PharmaLegacy; Piemonte Agency for Investment, Export
and Tourism; F.Hoffmann - La Roche Ltd.; Takeda Pharmaceutical Company Limited
Conference Sponsor
Genzyme; ImmuPharma PLC; Johnson&Johnson FierceBiotech
Conference Supporter
Aura Capital Partners
Media Sponsors
Citigate Dewe Rogerson; Business Wire; Nature Publishing Group; Zoomedia;
Pharmalicensing Ltd,
Media Supporters
BioBusiness; BioCentury; BioWorld Today; European BioPharmaceutical Review;
GoingPublic Media AG; PharmaVentures Ltd.
endclip
ONCY listed as a presenter Oct 11-13 at BPE and at BPC on Ocy 14
onco_investor
Oncolytics REOLYSIN On The RAS Warpath - Seeking Alpha Post
http://seekingalpha.com/instablog/383010-chinook-traveler/28237-oncolytics-reolysin-on-the-ras-warpath
Notable quotes.
"As Oncolytics Biotech have stated, a significant clinical opportunity for REOLYISN is in the treatment of patients with metastatic cancers including colorectal and non-small cell lung cancer who have a mutated KRAS gene...
A U.K. translational clinical trial investigating REOLYSIN in patients with metastatic colorectal cancer has also been initiated. A clinical benefit response rate of 93% was obtained in treated lesions of a U.K. Phase II combination radiation and REOLYSIN trial.
Oncolytics announced that it has successfully completed an initial 100-liter production run of REOLYSIN under cGMP conditions and completed the lyophilization (freeze-drying) formulation development program a stable form for pharmaceutical distribution should their product be approved by the FDA. Oncolytics has more than 200 patents issued worldwide which cover mainly reovirus and other oncolytic viruses (adenovirus, herpes simplex virus).
...All clinical trials to date have clearly demonstrated a significant improvement of seriously ill cancer patients."
endquote
The value of running all these parallel Phase II studies will be evident someday as the breath of this product's potential market gets larger as we go along. Does anybody else get the feeling ONCY is fueled and ready to launch?
onco_investor
Dr. John Marshall educates us on KRAS
In this video blog, Dr. John Marshall (Georgetown University) explains how recent findings about the KRAS gene have profound implications both for our approach to colorectal cancer as a disease, as well as for treatment.