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Cell Cycle Synchronization and Reovirus Oncolysis
Effect of Cell Cycle Synchronization on Tumor Sensitivity to Reovirus Oncolysis
Thanks Matdu on V2
Research published Sept 14th, 2010 by our great UK research team. IMO a great display of teamwork here. No doubt we are still filing IP that could have future value.
Mol Ther. 2010 Sep 14. [Epub ahead of print]
The Effect of Cell Cycle Synchronization on Tumor Sensitivity to Reovirus Oncolysis.
Heinemann L, Simpson GR, Annels NE, Vile R, Melcher A, Prestwich R, Harrington KJ, Pandha HS.
Oncology, Postgraduate Medical School, University of Surrey, Guildford, UK.
Abstract
The potential for increased sensitivity of tumor cells to oncolytic reovirus by altering the normal cell cycle using clinically available pharmacological agents was investigated.
B16.F10 mouse melanoma cells were partially synchronized with hydroxyurea, thymidine, or by mitotic shake-off. Cell survival was determined using MTS [3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)- 2-(4-sulfophenyl)-2H-tetrazolium)] survival assay and virus yield in tumors by plaque assay.
An enhanced sensitivity to reovirus was observed following the removal of either hydroxyurea or thymidine from the culture medium (P < 0.0001). The greatest survival difference compared to normal cycling cells was noted when the majority of cells were in S and G2/M phases, and was associated with increased viral replication. Cells collected by mitotic shake-off were nearly devoid of cells in S phase and were less susceptible to reovirus-induced cell kill than their nonsynchronized counterparts (P < 0.0001). In vivo combination of hydroxyurea followed by intratumoral reovirus resulted in reduced tumor growth and increased survival compared to monotherapy (P = 0.0041) at 15 days. Increased amounts of virus were retrieved from tumors from mice treated with sequential hydroxyurea/reovirus compared to concomitant treatment or reovirus monotherapy. These data justify clinical evaluation of this approach supported by the extensive experience, low cost, simple administration, and availability of hydroxyurea.
Rodman and Renshaw Company Presenation by Doug Ball Sept 9th, 2010
CNBC Blurb at
http://www.classic.cnbc.com/id/39074869
The company investor presentation was updated for this presentation
http://www.oncolyticsbiotech.com/pdf/ONCY_Investor_Presentation_Sept_10_2010.pdf
I listened to this and thought Doug presented a great picture of the company and what is about. The slides 10 and 11 are very graphic but show what kind of dramatic responses that are being seen in some cases.
Media Advisory - Oncolytics Biotech(R) Inc. to Present at Rodman Renshaw Annual Global Investment Conference
Published: Thursday, 9 Sep 2010 | 7:30 AM ET
CALGARY, Sept 09, 2010 /PRNewswire via COMTEX/ -- Mr. Doug Ball, Chief Financial Officer of Oncolytics Biotech Inc. (TSX: ONC, NASDAQ: ONCY), will present a corporate overview of the Company at the Rodman ; Renshaw Annual Global Investment Conference on Tuesday, September 14th, 2010 at 10:25 a.m. EDT.
The conference takes place from September 12th to 15th at the New York Palace Hotel in New York, NY.
A live audio link to the webcast presentation is available at: www.wsw.com/webcast/rrshq18/oncy 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 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.
Canaccord Genuity webcast by Brad Thompson, CEO
Thanks to PDT on V2
Transcript Canaccord Genuity webcast by Brad Thompson, CEO of Oncolytics Biotech, on Aug 8, 2010
Good morning and thank-you for taking your time today to come and listen to Oncolytics.
Before I start I'd like to direct your attention to our forward looking statements and recent filings with the Securities and Exchange Commission and the various equivalent commissions in Canada.
Today I'd like to talk about our clinical stage product which is called Reolysin which is an unusual product, it's a live agent, it's a virus that we are looking at a number of different indications in Oncology. What I'd like to focus your primary attention on today is to talk about our phase III study which started treating patients last month in the US, UK and Belgium, which is for second line or platinum refractory head and neck patients with a very serious emphasis on squamous cell carcinomas. And we've expanded this platform into a number of other phase IIs looking at first line non-small cell lung, metastatic melanomas, and first and second line squamous cell lung non-small cell lung cancers and we're also - I'll talk briefly about another interesting indication which is pancreatic cancer in combination with Gemzar.
We have a very good I.P. portfolio and we're already manufacturing the product at commercial scale. For example, a 100 litre batch, which is the scale we are at now, a single one produces enough product for an entire clinical program and produces between 150 million and 200 million dollars worth of product, so I think we are pretty much there on manufacturing.
Reolysin contains a virus called the reovirus which is a very common environmental virus. If you were flying in during the rain last night and were walking around outside you were actually splashing it on your leg as you were walking through puddles. Anywhere between 70 and 100% of any adult mammalian population has actually been exposed to the virus by the time that they reach adulthood. But it is considered to be one of a large group of viruses that actually doesn't cause disease in humans which is the "O" in reo, which is "orphan". It's asymptomatic. Of course the way that we are delivering it is a little different than you'd get it in nature so we did have to spend a little time and energy on safety.
The only reason we are interested in it is that it has an absolute requirement to grow in cells that have the RAS growth pathway constitutively activated and it also acts primarily as a cytotoxin: it will infect a cell if the RAS pathway is activated, it will productively replicate and kill the cell in about 3 days and then progeny viruses will spread to surrounding tissue. This would be a curiosity only if this condition wasn't associated with diseases. About half of neurofibromatosis patients, for example, have a RAS pathway involvement, there's a couple of sub-cell classes of rheumatoid arthritis that have a RAS pathway involvement and the one that is of interest to us which is Oncology - about two thirds of all primary carcinomas have a RAS pathway involvement and between 90-100% of metastatic disease. And as you would expect given that differential we actually do get preferential responses in metastatic disease over primary. And of course that translates into a very, very large patient load. Every year in the Western world will come down with a new primary tumour that has a RAS pathway involved with it.
Also, our pipeline as we have it today. I'll be talking about our phase III study in head and neck in combination with carbo-tax, carboplatin paclitaxel, and briefly talking about some of our follow-up studies particularly the non-small cell lung study which is in phase II, briefly about squamous cell carcinoma for the first time which is kind of fun, pancreatic cancer and our colorectal study.
The phase III study just started enrolling last month, we actually announced opening of the study late in May and enrolled our first few patients in the first three countries early of last month and we are looking at patients with platinum refractory not platinum resistant - platinum refractory head and neck cancers. It's a two part study, it's fully blinded, the control arm is getting carbo-tax saline and the treatment arm is getting carbo-tax Reolysin, and it's interesting in that we are using adaptive statistics in the second part primarily. It was approved in the U.S. under a S.P.A. last fall, in the U.K, Belgium, and Canada subsequent to that and as you'd expect the primary endpoint is overall survival. One of the things that we discovered in our phase II study is that we do seem to get very distinct patient populations and so we are sampling very freely in this study, in order to determine markers potentially as there have been none determined as of yet, and so we are looking at EGFR, RAS, human papiloma virus status and a variety of other things to enable in the future hopefully to be able to screen in and screen out patients. There will be 80 patients in the first stage and enrolment is anticipated to be concluded in Q1 of next year, and so by ASCO next year we will have a primary read out of that first group and the second stage, which is adaptive, is most statistically likely to have 200 patients. So two years from now when I'm standing here we will actually be able to talk about final results from the entire 3A/3B structure.
The reason that we are interested in head and neck is worth talking about for a couple of minutes. Our phase I study with carbo-tax and Reo had a heavy weighting of head and neck patients in it, primarily because of the investigators practices that were on the study. We were surprised I'd have to say with the responses and lifespan - at least anecdotal lifespan - extensions that we received in the phase I study and so decided to run two phase II studies, single arm studies, with just head and neck patients with a very high concentration on squamous cell. We completed the U.K. study which had 23 patients and we are finishing off the U.S. study as we speak.
Now, what we are comparing it against is historical just to see if we have activity in the area of interest and we are primarily comparing ourselves against work that Jan Vormorken, who was the P.I. for the Erbitux registration study in Europe, in his experience and using the data from his various studies. On carbo-tax alone his estimate is, is that the response rate should be no higher than 10% for this patient group, probably less than that. Erbitux pushes that to 12 or 13% arguably, with a PFS of 2 months or less, and this is where it is very important to make sure you stick with the patient group you are looking at, 4 1/2 month median for refractory patients which is quite different than platinum failed patients. The 23 patients that we ran in our phase II study in Europe, and we reported this in June at ASCO, of the 19 evaluable we had a response rate of more than four times that, and a clinical benefit rate of just under 3 in 4 patients, and because the patients are still alive we reported the mean, but we are just under 9 months mean for survival which is just about double what we were expecting to see. From the basis of this we decided to run this phase III study. This very strong signal for this particular indication, especially platinum refractory and squamous cell populations, which tend not to respond well to conventional therapy. One of our clinical advisors said well not only is the response rate different, but the types of responses that you are seeing is quite different, and we expected this. Whether we see a response in the primary or not, almost universally we will see a response in metastatic lesions, which is highly unusual.
This is a case of lung lesions, they're on the left side top and bottom, the before and after, and post 6 cycles is around 4 1/2 to 5 months in this particular case and you are getting complete resolution of the metastatic lesions in the lungs and virtual resolution, in this case, of the primary. We also see this typical effect in nodes and liver lesions as well.
This patient was actually a nasopharyngeal, which we didn't have many of in this study. The primary actually had a fairly minor response, had a 10% regression, but the liver which is that grey mass in the upper left hand side, the descending colon on the right, had those large dark lesions scattered throughout and you are getting about a 96 or 97 volume regression in about 6 weeks and this is very typical for Reo to get these types of responses especially in metastatic lesions and in head and neck that is the primary cause of death typically is mets. So we are quite, quite pleased about this, but also quite sensitive that we have to focus on evaluating response in metastatic lesions on a differentially than primary.
Just a couple of visual ones, this particular patient actually presented with this lesion about 2/3 that size for his primary treatment of radiation, which I'm not sure what he thought that was on the side of his neck, but after he failed that and two platinum courses we put him on study and again, after about 6 weeks you're getting complete resolution of the superficial component of the tumour.
And this one I tend to show just to show the rapidity of which these tumours grow, all of these patients are rapidly growing, are rapidly progressing patients both in their primary and metastatic lesions. The pre-treatment slide in this particular case is on the day of consent, the middle slide is 18 to 19 days later when we started therapy, and again that's 6 weeks after on the right there when you've resolved all of those superficial tumours and you can see the underlying radiation damage left over from earlier therapy. So it's very, very consistent with what we see; that 40-odd percent of the patients that we get responses, respond extremely rapidly, usually you are starting to notice tumour differences within the first cycle and usually get this kind of resolution after 2 or 3 cycles. Another 30 percent or so, you are getting stable disease, they are stable disease while they are on therapy, and once they are off therapy their tumours will start to grow again, either very quickly or some months later, and then 25 percent or so of the patients grow right through the therapy altogether and hopefully we can find out what that is.
One of our clinical advisors noted to us in the middle of our phase II study, that squamous cell, these kind of responses in squamous cell are quite unusual, but there are other indications that are squamous cell based, of course, and they are essentially the same disease just in a different location. And so the first one that we thought of looking at was squamous cell lung and just for fun, to show one's studies very early on, this particular patient has - this is the first patient on our phase II in the States in squamous cell, the green arrow, the top green arrow on the left is the primary which is a double fist size, on end, tumour in the right upper lung and you can see as it progresses post cycle 2 - it's very quickly, that's only about 4 weeks out - you are getting about a 70% volumetric regression and it continues to shrink after 4 cycles and that's where this patient is now, and you're also seeing plural mets similarly responding. If we can maintain these kinds of responses in this particular study I think it would be very encouraging. There's been some unfortunate failures in squamous cell lung recently and this is highly encouraging, though obviously just a single patient. We have another 5 or 6 patients that will be reading out in the very near future.
Obviously going ahead and screening is what people are doing in Oncology today, and we are as well. If you look at tumours with a RAS pathway activation, they have a number of subsets in them that are already commercially important. EGFR activation or mutation signals through RAS so those are a subset of the whole RAS pathway activation universe, and of course they have signification sales with a number of products in that particular area. Two years ago at ASCO people noted that non-small cell lung and colorectal patients that have KRAS as well as EGFR mutations, that the EGFR based drugs weren't working particularly well. Its a little fuzzier with non-small cell lung than it is with colorectal, but that provided an opening to us to pre-screen patient populations with those two mutations, and I'll be talking about that briefly. But you also start thinking about screening by indication where you have almost universal RAS activation and there are a couple of cases where that's particularly the case and so you can pre-screen by disease as well as by actually doing the screening.
First, with non-small cell lung, in our study we are screening for KRAS and EGFR status and between 15-20% of non-small cell lungs are KRAS mutated and that's the patient population that we are after. So if a patient comes into this study they get screened for EGFR and KRAS, if they are KRAS negative they go onto standard of care which is carbo-tax and one of the EGFR drugs. If they have the KRAS mutation they are excluded from that and are treated on our study. We are a significant way through the enrolment on this study and I would expect we would be announcing top-line data hopefully later this year.
<??? 14:33> with colorectal cancer, we had clinical data on carbo-tax combinations so we could go straight into phase II, but we needed to go back into the lab because of the Irinotecan component of FOLFIRI, and we're just about to start enrolment in a phase I study with REO combined with FOLFIRI - again, same thing, while patients fail first line in this case are screened for EGFR status and KRAS, if they have the KRAS mutation they'll go onto our study. In this case its a much bigger percentage however, it's almost half of the patients in 2nd line colorectal are now being excluded from EGFR status because they have KRAS mutations so this is a significant patient group for us.
And lastly, the one that I find kind of interesting is one that we've been working on for quite some time, is that pancreatic cancer is essentially 100% RAS activated, about 95% KRAS mutant and the rest are RAS activated for a variety of other reasons, so the indication is pre-screened for RAS activation, and certainly in the lab, REO's cured in combination with Gemzar in animal models for panc. This, again, is a very early patient out of this particular study, but you'll notice this is post-cycle 1. So this patient's scans were a few weeks apart from the start to the after, and there is two things here - the primary which is the bottom lower left and right and the pancreatic head has a partial response already, and the top which is a metastatic lesion of hepatic hilar lymph node is also a strong partial response. Very aggressive responses, very atypical for Gemzar all by itself in this particular case. And so, again, we are hoping that a few patients further on will have something a little more interesting to show you, but it is certainly encouraging very early on to see these kind of very aggressive results, again, very quickly, which is very typical of REO combinations if you are going to get a response.
From the perspective of safety I think we've gone above and beyond because this is a live agent. We've now treated over 330 patients of our own and the NCI has treated another probably 40 or 50 by now. Most of these patients have been treated at intravenous dosages at our standard I.V. dosage which is three times ten to the tenth. We still don't have an M.T.D. and the tox is completely consistent. Usually on day 3 of a 5 day cycle, you'll get a mild fever, a mild arthralgia, and grade 1 or grade 2 fatigue. Blood chemistry is usually low grade lymphopenia and nutropenia and about 6% of the patients get transient lymphopenia and nutropenia and it's very atypical in that it presents and resolves on the same day which is not classic lymphopenia by any standard. And it's very, very consistent and it doesn't exacerbate or stack, usually, with other drug's toxicities. The exception being that if you have grade 3 or grade 4 nutropenia/lymphopenia induced by Gemzar, I would be cautious at using this in combination with high dose REO, I think that's not prudent - would be a nice way of saying it.
We've got over 200 patents issued worldwide including 36 U.S., 34 of which are specific to REO and a couple that are with other viruses, and they cover everything from composition of matter, to pharmaceutical use and manufacturing and so on. We've done an incredible job of putting together an I.P. base that hopefully will withstand challenge at some future date.
And as I mentioned, manufacturing has resolved itself quite nicely, we are using the final formulation for commercial use now in our phase III study and certainly our cost of goods is expected to be very, very , very low for a biologic given this current process.
We trade both on NASDAQ and on Toronto, Cannacord is actually the lead agent, listing us on both, and we've had a long association with Cannacord. We have cash to take us to next fall, which is 4 or 5 months after the read out of our primary data on our phase IIIA and finish up all of our phase II studies.
Just quickly in summation: our candidate's in the clinic is called Reolysin is in a phase III study that will have primary data a year from now and final data two years from now and we have a number of other phase II studies that will read out - mostly between now and next year just prior to our phase IIIA data, and I'd like to thank you for your time and attention today.
Dr.Goel's 2010 ASCO Award - Reovirus Colorectal Research
http://www.asco.org/ASCOv2/Meetings/ASCO+Annual+Meeting/2010+ASCO+Daily+News/Monday,+June+7/Grants+and+Awards/Dr.+Sanjay+Goel+Receives+2010+Advanced+Clinical+Research+Award+in+Colorectal+Cancer
More on Dr Sanjay Goels's ASCO award from the ASCO site. Interesting to see Dr Goel dedicate his near term future work to studying the use of Reovirus after he was the PI of the Montefiore Phase I systemic Reovirus monotherapy trial back several years ago. Note the highlighted commments from Dr Goel.
Dr. Sanjay Goel Receives 2010 Advanced Clinical Research Award in Colorectal Cancer
The Advanced Clinical Research Award (ACRA) in Colorectal Cancer is designed to fund investigators who are committed to clinical cancer research and who wish to conduct original research not currently funded. This year, The ASCO Cancer Foundation ® is proud to present the 2010 ACRA in Colorectal Cancer supported by Genentech Biooncology™ to Sanjay Goel, MD, MS, of the Albert Einstein College of Medicine, Montefi ore Medical Center. The $450,000 grant will be awarded over 3 years to Dr. Goel and his research team as they embark on his project, “A Novel Pharmacogenomic-based Therapeutic Approach for Patients with K-ras–mutant Metastatic Colorectal Cancer (mCRC) Using an Oncolytic Reovirus.”
Dr. Goel, originally from Bangalore, India, received his medical degree from the Christian Medical College, Vellore, India. As an internal medicine resident in New York, he actively managed patients with cancer, and that was when he decided to choose the field of oncology. “I decided to pursue this subspecialty for two reasons: it allows me to take care of the entire patient, which requires both internal medicine and oncology skills, and it offers tremendous opportunities for research that can truly make a difference in patients’ lives,” Dr. Goel explained in an interview with ASCO Daily News.
With help from the funding he will receive from the ACRA in Colorectal Cancer, Dr. Goel plans to combine his passion for clinical research with his longstanding desire to help the 50,000 patients who die as a result of colorectal cancer each year, specifically those patients with K-ras–mutated metastatic disease. He also plans to study other potential biomarkers of drug activity and continue with more in vitro and in vivo studies on the potential use of this combination and their mechanistic basis of synergy.
Currently, the most common treatment option for colorectal cancer involves front-line FOLFOX/bevacizumab therapy followed by irinotecan (without or with 5-FU, as in FOLFIRI) or irinotecan plus the anti-epidermal growth factor receptor antibodies cetuximab or panitumumab. However, Dr. Goel noted that these antibodies are ineffective for the 40% of patients with metastatic colorectal cancer whose disease is K-ras mutated, which significantly limits the therapeutic options for these patients. He believes the lack of treatment options that exist for this patient group has highlighted an urgent, unmet medical need to develop novel therapies in this setting.
“The limited therapeutic options these patients have and my primary interest in drug development — particularly in colorectal cancer — prompted my interest in this topic,” explained Dr. Goel. “Currently this group of patients is an ‘orphan group’ with limited therapeutic options after two lines of therapy.” For these patients and for this disease, he believes that any improvement or expansion of treatment options “will lead to significant benefit.”
Dr. Goel’s research is, in part, rooted in uncovering the anticancer activity of the combination of reovirus plus irinotecan. Dr. Goel and his colleagues at Albert Einstein have studied a panel of CRC cell lines and observed synergistic anti-cancer effect. “Reovirus serotype-3 Dearing strain is a doublestranded RNA virus that selectively replicates in, and is cytopathic to, K-ras–activated cancer cells,” he told ASCO Daily News. “Community- acquired reovirus infection is generally mild with flu-like gastrointestinal and respiratory symptoms,” Dr. Goel noted.
According to Dr. Goel, investigators have identified in vitro activity of the reovirus in K-ras mutant cancer cell lines, adding that the “strong in vivo activity in animal models, its human safety data, and the urgent need for novel therapies in this setting represents a strong rationale to develop reovirus for this indication.” He is eager to determine whether the combination of reovirus with irinotecan is clinically valid.
As Dr. Goel moves forward in his career and with his investigations, he remains enthusiastic about his current interests and future clinical and translational research endeavors. He also plans to continue to combine his passion for patients and their wellbeing with his desire to conduct research that can have a lasting effect on their lives. “Good clinical care forms the basis for clinical research, and I will continue to promote good bedside and clinical care combined with clinical research,” he said.
Dr. Goel told ASCO Daily News he would also like to thank Sridhar Mani, MD, and John Mariadason, PhD, who have helped him throughout his career and guided him to this point: “I have learned and gained a tremendous amount of knowledge and insight from them,” he added.
ONCY~
oncy
ONCY~
ONCY presenting at 2010 Canaccord Growth Conference today
Webcast today at 10:30 EDT
insert-text-here
PRESS RELEASE
Aug. 5, 2010, 7:30 a.m. EDT · Recommend · Post:
Media Advisory - Oncolytics Biotech(R) Inc. to Present at 30th Annual Canaccord Genuity Growth Conference
CALGARY, Aug 05, 2010 /PRNewswire via COMTEX/ -- Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. (CA:ONC 3.31, 0.00, 0.00%) (ONCY 3.23, -0.02, -0.62%) , will present a corporate overview of the Company at the 30th Annual Canaccord Genuity Growth Conference on Tuesday August 10th, 2010 at 10:30 a.m. EDT. The conference takes place from August 10th - 12th at the InterContinental Hotel in Boston, MA.
A live audio link to the webcast presentation is available at:
http://www.wsw.com/webcast/canaccord2/oncy/ 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 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.
Copyright (C) 2010 PR Newswire. All rights reserved
Oncolytics Begins Final Tests On Viral Cancer Drug
Nice mention in the online Wall Street Journal - July 26th, 2010
http://online.wsj.com/article/BT-CO-20100726-707662.html?mg=com-wsj
By Laura Kusisto Of DOW JONES NEWSWIRES TORONTO (Dow Jones)--Within two years, a few small drug companies could begin to change the way we treat cancer. Oncolytics Biotech Inc. (ONC.T) is one company in the final stages of testing viruses that could stabilize or shrink tumors with few side effects.
Calgary-based Oncolytics has started enrolling advanced head and neck cancer patients in Phase III trials using a combination of chemotherapy and Reolysin, a drug made from a mild virus.
Reolysin "has the potential to revolutionize cancer therapy," Alan Ridgeway, an analyst at Paradigm Capital, wrote in a recent report. The drug "will likely ultimately be approved to treat multiple forms of cancer," Ridgeway wrote, initiating coverage at a buy rating. He told Dow Jones that Reolysin is more promising at this stage than most therapies he's seen.
The trial has received the go-ahead in the U.S., U.K., and, just last week, Canada. Oncolytics will have preliminary data from the U.S. trial in a year, and it will likely have final data by 2012. The drug could receive U.S. Food and Drug Administration approval the following year.
The reovirus, from which Reolysin is made, only replicates in cells with an activated Ras pathway, rare in normal cells. About two-thirds of cancer cells have mutations that allow the injected virus to replicate until it eventually begins to destroy the cancerous cells. Because the drug targets mainly cancer cells, the main side effect is a mild fever.
In the Phase II trial, Reolysin given with chemotherapy had what Chief Executive Brad Thompson calls "an unusual response rate." Forty-two percent of patients had a partial response or better, compared to fewer than 10% of patients who have at least a partial response to current treatment.
Viral therapies have been showing promise in Phase II studies, but those results are based on too small a sample size to be conclusive, says William Phelps, the director of pre-clinical cancer research for the American Cancer Society. Viruses aren't the only potential breakthrough in cancer research, but they're one of several new therapies that have shown promising early results in combination with chemotherapy, Phelps says.
Three different companies that have been working on viral therapies for more than a decade hope to see final results in the next one to three years. Massachusetts-based Biovex Inc. is two-thirds of the way through a Phase III trial using a modified herpes virus to treat melanoma, and expects results in a year. It's also about to begin a Phase III trial for treatment of head and neck cancer.
San Francisco-based Jennerex, Inc., with research facilities in Ottawa, hopes to begin a Phase III trial of a vaccinia virus therapy for liver cancer sometime next year. "We've all been working pretty hard for 10 years. At least in the whole field, there's been a lot of collaboration," the company's chief scientific officer, John Bell, said.
Some smaller drug companies have struggled to get financing in the last couple of years, but all three companies successfully raised money to continue trials. "It was one of the worst periods for financing I've ever seen," Oncolytics' Thompson told Dow Jones. But "we raised more money in 2009 than we've ever raised." The company made C$37 million by buying a small company with a failed clinical trial, exercising some of its warrants and raising C$20 million through an initial public offering.
Oncolytics, which has no revenue, has enough money to last until the third or fourth quarter of next year, with 12 different trials ongoing. The company has approval for a Phase II trial of Reolysin on non-small-cell lung cancer, which may help it get a partnership with a major pharmaceutical company, analysts say. Oncolytics is in active discussions with major drug companies, but Thompson wouldn't disclose more.
Company website: http://www.oncolyticsbiotech.com
-By Laura Kusisto, Dow Jones Newswires, 416-306-2028; laura.kusisto@dowjones.com
.1201 NITE x .13 ETMM
NITE is at .1398 also on the ask
Late-Stage Products Looking for a Home
Criteria for inclusion:
a) Program has completed phase-2b or later and is non-partnered; AND
b) Company lacks the financial resources to commercialize the product on its own.
Edits: Added ONCY who have now started a Phase 3 in refractory SCC Head & Neck Cancer with a FDA SPA in hand. ONCY is also more than midway through a closely watched Phase 2 trial for first line kras+ NSCLC lung cancer. Preliminary data in this Phase 2 trial is due in Q3-2010. ONCY may partner or raise funds after this data is released as the company is currently only funded to complete and analyze the first-look portion of the Phase 3 at this time.
Company Product Phase Indication (notes)
======= ======= ===== ==================
ARNA Lorcaserin NDA Obesity
ARYX Budiodarone 2B Atrial Fibrillation
ARYX Tecarfarin 3 VTE prevention (failed initial ph-3)
BPAX Libigel 3 Female Sexual Desire Disorder
DYAX Kalbitor US app acute HAE (seeking ex-US partner)
HNAB Marqibo 2B ALL (ENZN failed acc. approval in NHL)
JAV Dyloject NDA Post-op pain (approved in UK)
JAV Ketamine 3 Acute pain
ONCY Reolysin 3 SCC Head & Neck cancer (ph-3 SPA)
OREX Contrave NDA Obesity
OXGN Zybrestat 3 Anaplastic thyroid cancer
MNKD Afrezza BLA Diabetes (CRL rec’d 3/15/10)
Pharming Rhucin BLA HAE (CHMP decision expctd Jun 2010)
SOMX Silenor apprvd Insomnia (low dose of generic doxepin)
SVNT Krystexxa BLA Gout (response to CRL submtd 3/30/10)
VVUS Qnexa NDA Obesity
Dr. Sanjay Goel Receives Prestigious ASCO Research Award
http://www.digitaljournal.com/pr/50554
Montefiore Oncologist Sanjay Goel, MD, Receives Prestigious ASCO Research Award
PR Newswire
BRONX, N.Y., June 7
Dr. Goel Recognized for His Unique Approach To Colorectal Cancer Research
BRONX, N.Y., June 7 /PRNewswire-USNewswire/ -- Sanjay Goel, MD, MS, medical oncologist and researcher at Montefiore Medical Center and Albert Einstein College of Medicine, has been presented with The American Society of Clinical Oncology Cancer Foundation's (TACF) Advanced Clinical Research Award for his unique, patient-oriented approach to colorectal cancer research. Dr. Goel received the award at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
TACF grants and awards provide vital research funding and career-developing support, illustrating the Foundation's commitment to supporting both clinicians and cutting-edge research in oncology practice. Dr. Goel is one of three recipients of the TACF's Advanced Clinical Research Award, which is presented annually to physicians who have 5 to 10 years of experience and are full-time faculty members in a clinical setting at an academic medical center. Each winner receives a 3-year award totaling $450,000 to support original research that is currently not funded.
Dr. Goel received the award for his research project entitled, "A Novel Pharmacogenomic Based Therapeutic Approach for Patients with KRAS Mutant Metastatic Colorectal Cancer (mCRC) Using an Oncolytic Reovirus".
Colorectal cancer is responsible for 50,000 deaths annually, with the median survival of patients with metastatic disease of 24 months. The most common treatment for mCRC incorporates oxaliplatin (chemotherapy) and bevacizumab (monoclonal antibody) as a frontline therapy, and irinotecan (chemotherapy), either alone or in combination with anti-epidermal growth factor receptor (EGFR) antibodies as a second line therapy. However, these antibodies are ineffective in patients whose tumors test positive for a genetic variation known as KRAS mutation.
Dr. Goel's research focuses on the anti-cancer activity of reovirus serotype-3 in combination with irinotecan for the treatment of patients with KRAS mutant mCRC. Reovirus, a common community-acquired virus that causes mild flu-like gastrointestinal and respiratory symptoms, can also infect and cause degenerative changes in cancer cells. "Patients with KRAS mutant colorectal cancer are an 'orphan group' with limited therapeutic options, and any advance in their therapy can lead to significant benefits," Dr. Goel said.
"I am delighted that the ASCO Foundation has recognized and decided to support the innovative talent of one of our most promising young clinical investigators for work that expands the treatment options for patients with colorectal cancer," said Roman Perez-Soler, MD, Chairman of Medical Oncology at Montefiore, Director of the Division of Medical Oncology at Albert Einstein College of Medicine, and an Associate Director for Clinical Research at Albert Einstein Cancer Center.
Dr. Goel is a medical oncologist at Montefiore and Assistant Professor of Medicine at Albert Einstein College of Medicine. His research interests include cancer drug development and phase I oncology clinical trials. He received his medical degree from Christian Medical College in Vellore, India, where he also completed an internship. He obtained his residency in internal medicine at the State University of New York Health Sciences Center and completed fellowships in hematology and oncology at the University of Colorado Health Sciences Center at Denver, and the Montefiore/Albert Einstein program. Dr. Goel is board certified in internal medicine, hematology and oncology.
An ASCO member since 2000, Dr. Goel plans to continue focusing on clinical and translational research. "The best format for drug development is laboratory medicine with a patient focus that can be quickly translated to the bedside," he said. "I believe that good clinical care forms the basis for clinical research and I will continue to promote good bedside and clinical care combined with clinical research."
Montefiore Medical Center encompasses 126 years of outstanding patient care, innovative medical "firsts," pioneering clinical research, dedicated community service and ground-breaking social activism. A full-service, integrated delivery system caring for patients in the New York metropolitan region and beyond, Montefiore is a 1,491-bed medical center that includes: four hospitals -- the Henry and Lucy Moses Division, the Jack D. Weiler Division, the North Division and The Children's Hospital at Montefiore; a large home healthcare agency; the largest school health program in the US; a 22-site medical group practice integrated throughout the Bronx and Westchester; and, a care management organization providing services to 179,000 health plan members.
In 2008, The Children's Hospital at Montefiore was ranked as one of "America's Best Children's Hospitals" in US News & World Report's prestigious annual listing and also received honors in the magazine's 2009 edition. The Leapfrog Group lists Montefiore among the top one percent of all U.S. hospitals based on its strategic investments in sophisticated and integrated healthcare technology.
Montefiore is committed to meeting the healthcare needs of the future through medical education and manages one of the largest residency programs in the country. Montefiore is The University Hospital and Academic Medical Center for Albert Einstein College of Medicine and has an affiliation with New York Medical College for residency programs at the North Division.
Distinguished centers of excellence at Montefiore include cardiology and cardiac surgery, cancer care, tissue and organ transplantation, children's health, women's health, surgery and the surgical subspecialties. Montefiore is a national leader in the research and treatment of diabetes, headaches, obesity, cough and sleep disorders, geriatrics and geriatric psychiatry, neurology and neurosurgery, adolescent and family medicine, HIV/AIDS and social and environmental medicine, among many other specialties. For more information, please visit www.montefiore.org or www.montekids.org .
SOURCE Montefiore Medical Center
Novel Phase II Trial Designs
Yu Shyr, PhD
Vanderbilt-Ingram Cancer Center
from the AACR/ASCO Workshop - Methods in Clinical Cancer Research Aug, 2009
http://www.vailworkshop.org/files/2009/Syllabus/8-2-2009/Novel%20Phase%20II%20Designs/Yu%20Shyr-Novel%20Phase%20II_Lecture_Slides_08_02_09%20(2).ppt
An interesting read on cancer trial design
Phase II Cancer Trial Design Presentation from AACR 2009
ONCY’s Phase II NSCLC trial design is a single stage Fleming design according to the 2010 ASCO Abstract – This is not randomized. A presentation by Miguel Villalona-Calero & Donn Young was made at AACR 2009 and is a good read on current trial design.
From the ASCO abstract...
http://abstract.asco.org/AbstView_74_52799.html
"We have hypothesized those patients with EGFR-mutated, EGFR-amplified, or Kras-mutated NSCLC should all have a common downstream activated Ras pathway and will exhibit response to treatment with reovirus.
Methods: This is a Fleming single stage, single-arm, phase II study to evaluate the objective response rate and 6-month progression-free survival of reovirus in combination with P and C as first-line therapy in patients with metastatic NSCLC. Eligible patients are those with ECOG PS 0-2, adequate organ function, no prior systemic chemotherapy, and tumors with the specified genotype. Reovirus (3 x 1010 TCID50) will be administered intravenously daily on days 1-5, C (AUC 6) on day 1, and P (200 mg/m2) on day 1 of each 21-day cycle."
The original Villalona Young presentation can be found at...
http://www.vailworkshop.org/files/2009/Syllabus/8-2-2009/Phase%20II%20Trials/Villalona%20syllabus%20material%20phase%202.doc
By Miguel Villalona-Calero & Donn Young
The primary objective of Phase 2 cancer clinical trials is the determination of anti-tumor efficacy in a manner that provides information to allow one to decide if further studies of the drug or regimen are warranted. These studies to test regimens or agents for suitability for Phase 3 studies address the conflicting needs to accrue sufficient patients to better define efficacy, but to minimize the number of patients treated if the drug is ineffective. Current accepted Phase 2 trial designs include a wide range of single- and multiple-stage, randomized and single-arm designs using frequentist, Bayesian, or predictive probability designs, addressing single efficacy endpoints or multiple endpoints incorporating efficacy and safety. Commonly used Phase 2 design and outcomes measures are listed below.
Study Designs
Frequentist
-Gehan 2-Stage
-Simon 2-Stage Optimal
-Simon 2-Stage Minimax
-Fleming 1-stage
-Gehan-Simon 3-stage
-Randomized Phase 2
-Constant Arc-Sine
-Randomized Discontinuation
Bayesian
-Thall-Simon-Estey Bayesian
-1-Stage Bayesian
-2-Stage Bayesian
Tan Machin
Heitian
Endpoints Outcomes Measures
RECIST/WHO Response Rate = Progression-Free Rate
CR + PR = Disease-Free Rate
CR + PR + SD = Event-Free Rate
Time Point = Based-Biological Endpoints
6-month = Safety & Adverse Events
12-month = Multiple Endpoints
Continuous = Quality of Life
The two-stage Phase 2 design to minimize the number of patients treated with ineffective regimens was initially proposed in Gehan’s (Gehan et al, J Chron Dis, 1961) “Rule of 14” design with 14 patients accrued in the first stage followed by 25 patients overall if the first stage goal is met. While this design allows early termination for ineffectual regimens, it fails to address probabilities associated with the decision to recommend that the Phase 2 regimen be considered for subsequent randomized Phase 3 studies. Regimens with a low probability for "success" were recommended for subsequent large-scale randomized clinical trials.
A decision-based two-stage design was refined by Simon (Simon et al, Cont Clin Trials, 1989) whose procedure minimizes the expected sample size given specified response rates and * and * error rates. While a large number of possible trials are generated using his procedure, the investigator usually selects either the ‘optimal’ solution which minimizes the number of patients treated if the regimen is truly ineffective or the ‘minimax’ solution which minimized the overall sample size. The majority of Phase 2 trials are based on Simon’s design.
The two-stage designs usually address an efficacy endpoint of objective clinical response, recently codified using the RECIST criteria for solid tumors. Positive responses are commonly defined as either complete [CR] or partial [PR] responses.
Unfortunately, these response determinations fail to address biological endpoints used in the evaluation of cytostatic rather than cytotoxic agents. With these molecularly-targeted agents, stable disease [SD], quality of life, or improvement in symptoms may prove to be appropriate measures of therapeutic benefit, especially when potential improvements may be subtle. As noted by Ratain and Eckhardt (J Clin Oncol, 2004), more flexible measures of antitumor activity need to be distinguishable from no treatment or a placebo.
Rather than relying on the combination of [CR+PR+SD] as demonstration of benefit, Phase 2 trials often address time-dependent endpoints of progression-free or disease-free survival translated to dichotomous alternatives at a given time point; i.e., the proportion of patients free of progression at one year following initiation of treatment. Given the time period from initiation of treatment to the endpoint, two-stage designs often prove impractical and a Fleming (Biometrics,1982) one-stage design is used. Since a larger number of patients will be treated prior to a decision to embark on additional studies and due to limited information on the toxicity profile of a new agent, the single-stage designs frequently incorporate sequential early stopping rules for adverse events.
More recently, Korn et al (J Clin Oncol, 2001) proposed single-arm Phase 2 designs with comparisons with historical control data.
The lack of well-characterized historical data with which to make comparisons often limits one’s confidence that the historical data present a reasonable baseline from which to detect therapeutic improvements. Mick et al (Cont Clin Trials, 2000) developed a novel Phase 2 design for failure-time endpoints by comparing time to treatment failure or progression on the new regimen [TTP2] with the individual patient’s failure time or TTP1 observed with their prior regimen of treatment. If the new agent demonstrated a TTP2/TTP1 ratio of greater than 1.33, it would be considered effective and worthy of further study.
Randomized Phase 2 trials provide a mechanism to determine which of two regimens should undergo further study in the Phase 3 setting (Simon et al, Cancer Treat Rep, 1985). These trials usually randomize patients between one of two regimens differing by dose level, schedule, or specific agent. Heeding the cautions of Liu et al (Liu et al, Control Clin Trials, 1999) the randomized Phase 2 trial is not to be viewed as an inexpensive Phase 3 trial since the study is not powered for inferential comparisons between the treatment arms. With both arms incorporating two-stage designs, however, the randomized Phase 2 trial offers four specific decision points for determining regimen efficacy. Very recently, Wiand (J Clin Oncol, 2005) criticized the randomized
Phase 2 design in a situation (Dark et al, J Clin Oncol, 2005) where both arms in a trial met first and second stage goals offering the investigators a “pick the winner” dilemma in which other information such as quality of life, toxicity, and costs were involved in the selection of the “winner.”
The randomized discontinuation design (Kopec et al, J Clin Epidemiol,1993), which has recently been proposed for selection of antineoplastic agents by Rosner et al (J Clin Oncol, 2002), incorporates a time-dependent endpoint such as time to progression with disease response. Patients with stable disease are randomized to either continuation with the agent or a placebo (the discontinuation). Patients subsequently showing progression on placebo are then retreated with the agent to determine if disease stability can be regained. This design allows one to demonstrate the effectiveness of a cytostatic agent by distinguishing between disease stability due to the agent versus due to a naturally slow tumor growth rate. This design is most appropriate in diseases where tumor growth rates are slow, whereas with an aggressive/rapidly progressive malignancy, few patients would quality for randomization, limiting therefore the design’s effectiveness.
While frequentist design have predominated in Phase 2 clinical trials, Bayesian Phase 2 trials have become more visible following the pioneering work of Staquet and Sylvester (Biomedicine, 1977; Cancer Treat Rep, 1980) and extensive development by Thall (Biometrics, 1994, Stat Med, 1995, Stat Med, 1998), Tan and Machin (Stat Med, 2002), Heitjan (Stat Med, 1997), and Mayo and Gajewski (Cont Clin Trials, 2004). In single and two-stage designs, Bayesian designs allow the investigator to determine the probability that the true response rate exceeds a pre-specified target response or to determine the response interval that has a 95% chance of containing the true response rate. Using prior probabilities based on the investigator’s prior beliefs about the new regimen, the study design re-computes posterior probabilities based on observed data. While many Bayesian designs use continuous monitoring, studies may be adapted to a two-stage model.
Sample Size Calculation
Prior determination of the sample size that is needed to show an important difference is essential in a well designed Phase II study. Two errors can be made in a test of a hypothesis: 1- rejecting the null hypothesis when it is true (Type I Error, ?) (false-positive); or 2- not rejecting the null hypothesis when it is false (Type II, ?) (false-negative). Another important consideration is Power, which is defined as the probability of rejecting the null hypothesis when it is false, or of concluding the alternative hypothesis when it is true. In other words, Power is the capability of a study to detect a given difference of a given size if the difference really exists. Confidence intervals give the additional information of the variability of the estimate, given the upper limit and a lower limit with an associated probability. Many statisticians prefer to see confidence intervals, since they clearly illustrate the magnitude of the difference and make clear the role played by sample size.
Before you go to your statistician it is important to figure out the following points:
1-Do you want to consider studying single versus two proportions
2-What is the desired level of significance of the null hypothesis (p0)?, e.g., what is the response rate for conventional care
3-What chance should there be of detecting an actual difference (what power) associated with the alternative hypothesis (p1) is desired?
4-How large should the difference between the proportions (p1- p0) be in order for it to have clinical importance?
5-What is a good estimate of the standard deviation in the population? The value of the null hypothesis, determines in most cases the standard deviation
Studies of biologicals and molecularly targeted agents provide substantial challenges to trial design, since traditional RECIST/WHO criteria response rate may not be adequate to comprehensively assess the clinical benefit produced by the agent, and in some cases a surrogate marker in tumor, normal tissue or cells may be required to assess if appropriate tumor/stroma concentrations or the agent are being achieved. This may have implications of individualized dosing and schedule.
Given this complexity of design and outcome alternatives, the selection of a trial design requires close collaboration between the study investigator and clinical biostatisticians to clearly define study objectives, to select appropriate endpoints, to select a trial design, and to compute the required number of patients to be enrolled.
References
1)Gehan EA, The determination of the number of patients required in a preliminary and a follow-up trial of a new chemotherapeutic agent. J Chron Dis, Apr;13:346-53.1961
2)Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989 Mar;10(1):1-10
3)Ratain M, Eckhardt SG, Phase II studies of modern drugs directed against new targets: if you are fazed, too, then resist RECIST. J Clin Oncol. 2004 Nov 15;22(22):4442
4)Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982 Mar;38(1):143-51
5)Korn et al. J Clin Oncol, 2001 Clinical trial designs for cytostatic agents: are new approaches needed? J Clin Oncol. 2001 Jan 1;19(1):265-72.
6)Mick R, Crowley JJ and Carroll RJ. Phase 2 clinical trial design for noncytotoxic anticancer agents for which time to disease progression is the primary endpoint. Cont Clin Trials. 2000;21:343-359.
7)Simon R, Wittes RE Methodologic guidelines for reports of clinical trials. Cancer Treat Rep. 1985 Jan;69(1)
8)Liu PY., LeBlanc M, and Desai M. False positive rates of randomized Phase 2 designs. Control Clin Trials. 1999;20:343-352.
9)Wieand HS. Randomized Phase 2 trials: What does randomization gain? J Clin Oncol. 2005;23:1794-1795.
10)Dark GG, Calvert AH, and Grimshaw R Randomized trial of two intravenous schedules of the topoisomerase I inhibitor liposomal lurtotecan in women with relapsed epithelial ovarian cancer: A trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2005;23:1859-1866.
11)Kopec JA, Abrahamowicz M, and Esdaile JM. Randomized discontinuation trials: Utility and efficiency. J Clin Epidemiol. 1993;46:959-971.
12)Rosner GL, Stadler W, and Ratain MJ. Randomized discontinuation design: Application to cytostatic antineoplastic agents. J Clin Oncol. 2002;20:4478-4484.
13)Staquet MJ and Sylvester RJ. A decision theory approach to Phase 2 clinical trials. Biomedicine. 1977;26:262-266.
14)Sylvester RJ and Staquet MJ. Design of Phase 2 clinical trials in cancer using decision theory. Cancer Treat Rep. 1980;64:519-524.
15)Thall PF and Sung HG. Some extensions and applications of a Bayesian strategy for monitoring multiple outcomes in clinical trials. Stat Med. 1998;17:1563-1580.
16)Thall PF, Simon RM and Estey EH. Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes. Stat Med. 1995;14:357-379.
17)Thall PF and Simon R. Practical guidelines for Phase 2B clinical trials. Biometrics. 1994;50:337-349.
18)Tan S-B and Machin D. Bayesian 2-stage design for Phase 2 clinical trials. Stat Med. 2002;21:1991-2012.
19)Heitjan DF. Bayesian interim analysis of Phase 2 cancer clinical trials. Stat Med. 1997;16:1791-1802.
20)Mayo MS and Gajewski BJ. Bayesian sample size calculations in Phase 2 clinical trials using informative conjugate priors. Cont Clin Trials. 2004;25:157-167.
21)Basic & Clinical Biostatistics Dawson-Saunders
REO-021 PII Trial Update San Antonio Nightly News
This SCC Lung cancer trial was just started in April of this year so still in the early stages but it is hard not to get a good feeling from seeing results like these publicized as it should help the enrollment pace. Coverage from two of the major news stations in San Antonio, Texas.
First we have FOX 29 News in San Antonio, Texas
http://www.foxsanantonio.com/newsroom/top_stories/videos/vid_2266.shtml
and then we have...
KENS News 5 San Antonio, Texas
http://www.kens5.com/news/health/SA-lung-cancer-patients-are-helping-test-a-new-novel-approach-to-attacking-the-killer-disease-91621924.html
Thanks for RJC and Matdu for the digging and as has been pointed out by a Bridger the dosage of the Reolysin vial in this new Phase II SCLC trial shows a 50% increase in active viral particles/ml to 4.5x10p10 TCID.
Phase II Starts Treating Patients Pancreatic Cancer
Targets front line therapy in combo with Gemcitibine for chemo naive patients with advanced or metastatic pancreatic cancer, paid for by the CTRC in Texas
http://finance.yahoo.com/news/Oncolytics-BiotechR-Inc-prnews-1657523235.html?x=0&.v=21
CALGARY, May 26 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) announced today that the Cancer Therapy & Research Center at the University of Texas Health Science Center in San Antonio (CTRC) has started patient enrolment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN(R) in combination with gemcitabine (Gemzar(R)) in patients with advanced pancreatic cancer. The Principal Investigator is Dr. Monica Mita of the CTRC.
"Pancreatic cancer has a dismal prognosis and no drugs have shown significant clinical benefit when added to gemcitabine for this patient population," said Dr. Mita. "We are extremely pleased to initiate this study and to have this promising treatment option for our patients."
"There is good rationale for moving forward with this first-line treatment combination, as our completed U.K. combination REOLYSIN and gemcitabine clinical trial (REO 009) in patients with various advanced cancers resulted in disease control for a majority of the evaluable patients," said Dr. Brad Thompson, President and CEO of Oncolytics.
The trial (REO 017) is a single arm, open-label, Phase 2 study of REOLYSIN given intravenously with gemcitabine every three weeks. Up to 33 patients are expected to be treated in this trial.
Eligible patients include those with advanced or metastatic pancreatic cancer with measurable disease who have not received any prior chemotherapy or biotherapy.
The primary objective of the Phase 2 trial is to determine the clinical benefit rate (complete response (CR) + partial response (PR) + stable disease (SD)) of intravenous multiple doses of REOLYSIN in combination with gemcitabine in patients with advanced or metastatic pancreatic cancer. The secondary objectives are to determine the progression-free survival, and to determine the safety and tolerability of REOLYSIN when administered in combination with gemcitabine.
This trial is part of a broad preclinical and clinical collaboration with the CTRC that will involve up to five, open-label, Phase 2 studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications.
About Pancreatic Cancer
The American Cancer Society estimates that 42,470 Americans were diagnosed with pancreatic cancer and 35,420 Americans died from the disease in 2009, making this type of cancer the fourth leading cause of cancer death in the United States.
For more information about pancreatic cancer, please go to http://www.cancer.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: http://www.oncolyticsbiotech.com/.
The Cancer Therapy & Research Center (CTRC) at The University of Texas Health Science Center at San Antonio is one of the elite academic cancer centers in the country to be named a National Cancer Institute (NCI) Designated Cancer Center, and is one of only three in Texas. A leader in developing new drugs to treat cancer, the CTRC Institute for Drug Development (IDD) conducts one of the largest oncology Phase I clinical drug programs in the world, and participates in development of cancer drugs approved by the U.S. Food & Drug Administration. For more information, visit http://www.ctrc.net/.
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 U.S. Phase 2 combination REOLYSIN/gemcitabine clinical trial for patients with pancreatic cancer, 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.
Phase III Enrollment Opened SCCHN
http://finance.yahoo.com/news/Oncolytics-BiotechR-Inc-prnews-3218592170.html?x=0&.v=23
Oncolytics Biotech(R) Inc. Announces Opening of Enrollment in Phase 3 Trial for REOLYSIN(R) in Head and Neck Cancers
PR Newswire
CALGARY, May 25
CALGARY, May 25 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ:ONCY) today announced that it has opened enrollment in its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. The Company had previously received approval from the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct the trial in those countries, respectively. Oncolytics intends to conduct the first stage of the trial at approximately 25 centres in the U.S., U.K., and Belgium but may elect to add centres in additional countries.
"Opening enrollment in our first pivotal study in an important step forward in our increasingly late stage REOLYSIN clinical program," said Dr. Brad Thompson, President and CEO of Oncolytics. "We expect enrollment to ramp up over the next quarter as additional centres come on line as the trial progresses."
As previously disclosed, 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 3x1010 TCID50.
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 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. Updated results from the U.K. Phase 1/2 trial reported in November 2009 demonstrated an overall response rate (PR and CR) of 42% and a total clinical benefit rate (PR + CR + stable disease) of 74%. The Company is currently conducting a confirmatory Phase 2 trial in the U.S. in patients with advanced head and neck cancers.
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 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.
SOURCE Oncolytics Biotech Inc.
2010 ONCY ASCO Abstract Posted - Ovarian
Not much in the early abstracts, all 3 trials were in early stages when the abstracts were submitted approx 5 months ago. This trial is a mono-therapy trial using both IP and IV delivery. It is also being run by the NCI
Phase I/II trial of reovirus serotype 3-Dearing strain in patients with recurrent ovarian cancer.
Sub-category: Ovarian Cancer
Category: Gynecologic Cancer
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr TPS253)
Abstract No: TPS253
Author(s): D. E. Cohn, G. Nuovo, M. C. Coffey, D. O'Malley, M. A. Villalona-Calero, M. R. Grever, D. Deam, J. A. Zwiebel, M. A. Phelps; Division of Gynecologic Oncology, The Ohio State University, Columbus, OH; The Ohio State University Medical Center, Columbus, OH; Oncolytics Biotech, Inc., Calgary, AB, Canada; Investigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD
Abstract:
Background: The prognosis associated with recurrent ovarian cancer is poor, and palliative therapy usually involves cytotoxic chemotherapy. In an effort to increase the survival and decrease the toxicity associated with treatment, increasing attention has been paid to targeted therapies. Reovirus Serotype 3-Dearing Strain (R) is a naturally occurring human reovirus. While reovirus infection is mild, R has been shown to replicate specifically in, and be cytopathic to, transformed cells possessing an activated Ras signaling pathway. In vivo, R has been demonstrated to be effective against solid tumors when administered into a tumor as well as intravenously (IV). In nude mice, intraperitoneal (IP) ovarian cancer cells are controlled with the administration of R. Given the improved survival with the use of IP chemotherapy in ovarian cancer, we set out to assess the feasibility and toxicity of the concurrent use of IV and IP R.
The trial was designed explicitly with correlative endpoints to establish the ability of IV and IP administered R to infect IP tumors and to assess the timing and method of reovirus infectivity in IP tumors.
Methods: Patients with recurrent ovarian cancer are eligible for this trial, and excluded if they had received more than one prior biologic agent for treatment of their disease. Patients are treated with a fixed dose of IV R days 1-5 (3 x 1010 TCID50/day) and an escalating dose of IP R days 1-2 (1 x 109 to 1011 TCID50/day) every 28 days.
The first cycle of therapy includes only IV treatment to provide the opportunity to assess the replication of R in IP tumors when the tumors are biopsied at the time of IP port placement; thereafter, each cycle includes both IV and IP administration of R. IP tumors are again biopsied before cycle 3, allowing for the assessment of replication of R after IV and IP administration. Samples of peritoneal fluid are obtained at the time of IP R for additional analysis.
A planned minimum of 18 patients will be treated on the phase I study, with an additional 27 on the phase II study utilizing the MTD (primary endpoint of the phase I study) of IP R (maximum 30+40=70); to date, 8 patients have been treated. The endpoint of the phase II study is the objective response rate, utilizing a 2-stage design.
2010 ONCY ASCO Abstract Posted - NSCLC
Phase II study of reovirus with paclitaxel (P) and carboplatin (C) in patients with metastatic non-small cell lung cancer (NSCLC) who have Kras or EGFR-activated tumors.
Sub-category: Metastatic
Category: Lung Cancer - Metastatic
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr TPS292)
Abstract No: TPS292
Author(s): E. T. Lam, G. A. Otterson, K. R. Donthireddy, J. Thurmond, E. Hade, M. C. Coffey, M. A. Villalona-Calero; The Ohio State University, Columbus, OH; The Ohio State University Medical Center and Arthur G. James Cancer Hospital and Solove Research Institute, Columbus, OH; The Ohio State University Center for Biostatistics, Columbus, OH; Oncolytics Biotech, Inc., Calgary, AB, Canada; The Ohio State University Medical Center, Columbus, OH
Abstract:
Background: Epidermal growth factor receptor (EGFR) dysregulation and Kras mutations occur commonly in NSCLC, both leading to downstream activation of Ras-dependent pathways. Kras mutations are associated with a worse prognosis, poorer benefits to chemotherapy, and resistance to EGFR tyrosine kinase inhibitor therapy. Targeting the Ras-dependent pathways is a major area of unmet therapeutic need in NSCLC.
Reovirus is a naturally occurring virus with few pathogenic effects in humans which preferentially infects and causes oncolysis in tumor cells with a Ras-activated pathway. Cells that express high levels of EGFR are also susceptible to reovirus infection. In preclinical studies, reovirus has been shown to induce host immunity and cell cycle arrest, acting synergistically with standard cytotoxic agents. Encouraging results have come from 18 completed or ongoing phase I and II studies with ≥ 200 patients with advanced solid malignancies treated with reovirus, alone or in combination with chemotherapy. The adverse effects of reovirus have been predominantly mild to moderate flu-like symptoms.
We have hypothesized those patients with EGFR-mutated, EGFR-amplified, or Kras-mutated NSCLC should all have a common downstream activated Ras pathway and will exhibit response to treatment with reovirus.
Methods: This is a Fleming single stage, single-arm, phase II study to evaluate the objective response rate and 6-month progression-free survival of reovirus in combination with P and C as first-line therapy in patients with metastatic NSCLC. Eligible patients are those with ECOG PS 0-2, adequate organ function, no prior systemic chemotherapy, and tumors with the specified genotype. Reovirus (3 x 1010 TCID50) will be administered intravenously daily on days 1-5, C (AUC 6) on day 1, and P (200 mg/m2) on day 1 of each 21-day cycle.
Correlative studies testing for mitogen-activated protein kinase (MAPK) phosphorylation in tumor specimens will be performed to confirm the presence of an activated Ras/MAPK pathway.
Thirty-six response-evaluable patients will be recruited. To date, we have enrolled and treated 7 patients.
2010 ONCY ASCO Abstract Posted - SCCHN
A phase I/II study of oncolytic reovirus plus carboplatin/paclitaxel in patients with advanced solid cancers with emphasis on squamous cell carcinoma of the head and neck (SCCHN).
Sub-category: Other Novel Agents
Category: Developmental Therapeutics - Experimental Therapeutics
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr 3080)
Abstract No: 3080
Author(s): E. M. Karapanagiotou, J. D. Chester, H. S. Pandha, G. M. Gill, M. C. Coffey, K. Mettinger, K. J. Harrington; The Royal Marsden Hospital, London, United Kingdom; St James's Institute of Oncology, Leeds, United Kingdom; University of Surrey, Guildford, United Kingdom; Clin-Reg Consulting LLP, Alexandria, VA; Oncolytics Biotech, Inc., Calgary, AB, Canada; Oncolytics Biotech, Inc., San Francisco, CA; Royal Marsden Hospital, London, United Kingdom
Abstract:
Background: Reolysin is an isolate of reovirus, a RNA virus which replicates in cells with activated Ras signaling pathway while sparing normal cells. We conducted a phase I/II dose escalation study of intravenous Reolysin in combination with chemotherapy. The study has completed enrollment.
Methods: Reolysin was administered to cohorts of 3 patients in escalating doses (3x109, 1x1010, 3x1010 TCID50) on days 1-5 while carboplatin AUC 5 and paclitaxel 175 mg/m2 were administered on day 1 of a 3-weekly schedule. Eligible patients had good performance status (ECOG PS: 0-2) with advanced cancers which were not amenable to curative treatment or were refractory to standard therapy for which paclitaxel/carboplatin was appropriate palliative chemotherapy.
Results: Thirty-one patients (24 males; median age 59 years) with head and neck cancer (n=24), melanoma (n=4), peritoneal/endometrial cancer (n=2) or sarcoma (n=1) received 147 cycles (median 5, range 1-8) of treatment.
In the dose-escalation phase of the study, there were no dose-limiting toxicities. Grade 3/4 toxicities included anaemia, leucopenia, neutropenia, lymphopenia, thrombocytopenia, infection and hypotension. Neutralising anti-reovirus antibody responses will be presented.
In the phase 1 study, partial responses (PR) were noted in 2 of 5 patients with head and neck cancer.
The Phase 2 study treated head and neck cancer patients at the maximum dose level (3 x 1010 TCID50) in order to further assess tumour response. In total, 19 patients with head and neck cancer received at least 2 cycles and are evaluable for response. Most were SCCHN refractory to previous platinum-based chemotherapy for recurrent/metastatic disease. PR was seen in 8 patients (42%) and SD in 6 (32%). One additional PR and 1 SD were observed among 4 patients with malignant melanoma. Final results for median OS and PFS will be presented.
Conclusions: Intravenous administration of reovirus in combination with carboplatin/paclitaxel is a safe and well-tolerated combination with promising anticancer activity in SCCHN. Further evaluation of this combination in a randomized phase III trial in SCCHN is underway.
Ken Goodrich runs a Seasonality Stock Indicator
I had Ken run his system for ONCY earlier last year and the results were interesting in the consistency of the patterns. ONCY usually has a bad November. The post he presented is at
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=43214940
Ken runs the iHub Seasonality Board at
http://investorshub.advfn.com/boards/board.aspx?board_id=1616
if anyone is interested. For some stocks I do believe this holds true but others are just data driven. To me the phenom is interesting.
onco_investor
<Whatever happened to doing several complete and proper trials to see the benefits. It seems to me that these guys are trying to cut corners and jumping into Phase III.>
<What is even more troublesome is that the FDA gave them a go for a Phase III.>
Obviously both of you have your own pre-concieved ideas based on little or no facts so I wont bother to educate you.
The Phase III ONCY H&N trial is Multijurisdictional
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=50292028
As was posted from an BioTuesday.ca article linked above, new details have emerged as to the planned Phase III (which should be starting enrollment in the next month)
<Since 2000, when Reolysin first entered the clinic, Oncolytics has enrolled some 330 patients in multiple Phase 1 and 2 studies. “When we lump all indications together, you see this pattern, where people have a three-in-four chance of stabilizing or having a tumour regress fairly significantly. And an even higher percentage in metastatic lesions,” he adds.
The company is now gearing up to start its first Phase 3 pivotal study with Reolysin in patients with advanced head and neck cancer at 25 centres in Britain and the U.S., under a special protocol assessment from the FDA, with plans to expand to Belgium, for multijurisdictional approval in Europe and Canada.
Reolysin will be tested in combination with two chemotherapy drugs, paclitaxel and carboplatin, versus chemotherapy alone in a two-stage clinical trial. The first stage is designed to enrol 80 patients. The second stage is adaptive, and designed to enrol between 100 and 400 patients, with the most probable statistical enrolment now being 200 patients, Dr. Thompson explains.
The company expects to complete enrolment of 80 patients by this Christmas and release some initial data next spring or summer, he adds. The primary endpoint is overall survival, with key secondary endpoints including progression free survival, response rate and duration of response, as well as safety.>
It should be noted that some of the sites chosen have already been enrolling Reolysin clinical trials for some time so the ramp up to this trial should be very quick. I hear you about the US enrollment rates. Many Phase II trials for ONCY have taken much longer than expected because of that. This issue highlights the need for a partner who can leverage their resources to enroll faster. Too bad you have to give away the store to partner to early. ONCY is treading a fine line between going it alone through the first H&N Phase III but will need a partner to go the distance which they have indicated will most likely happen after interim NSCLC RAS+ data later this year. Given the Reolysin MOA being effective in RAS+ cancers ONLY I give this trial the best chance of success theoretically.
onco_investor
ONCY Phase II REO+Low Dosage Radiation target patients that had previously failed to respond to treatments some of which were radiation.
Note the strong responders with what is considered just pallative radiation dosages.
http://www.integratir.com/newsrelease.asp?news=2130956011&ticker=T.ONC&lang=EN&ny=on
The trial is an open-label, single-arm, multi-centre Phase II study of REOLYSIN® delivered via intratumoural injection to patients during treatment with low-dose radiotherapy. Up to 40 evaluable patients, including approximately 20 patients with head and neck and esophageal cancers, and approximately 20 patients with other advanced cancers, will be treated with two intratumoural doses of REOLYSIN® at 1x1010 TCID50 with a constant localized radiation dose of 20 Gy in five consecutive daily fractions. Eligible patients include those who have been diagnosed with advanced or metastatic cancers including head, neck and esophageal tumours that are refractory (have not responded) to standard therapy or for which no curative standard therapy exists.
Other clinical trials being run by ONCY are listed at
http://www.integratir.com/newsrelease.asp?news=2130956011&ticker=T.ONC&lang=EN&ny=on
Randomized Phase II trials are considered the gold standard for clinical development however you also introduce a few issues that you have to decide what is in the best interest of the overall program.
Namely
1. If you already know that enrollment rates are low for all clinical trials then introducing randomized Phase II trials will only make this worse as many patients may decide not to enroll because they will not be assured of gettting Reolysin. The open label regular Phase IIs that ONCY has run gave them the best hope to enroll at rates that were acceptable. Even so the rates of enrollment have been very challenging as has been documented in many clinical trials not just ONCY.
2. Some people also beleive that giving terminal cancer patients a placebo is not ethical so you wait until you have to run a randomized Phase III before you introduce randomization... and then into the standard of care not placebo.
Another issue to consider is that Reolysin clinical testing is moving to test RAS+ and EGFR+ NSCLC and Colorectal patients instead of all NSCLC patients so you are getting right to the target population that has the specific deficiency that is the target of Reolysin's MOA. It has been announced that ONCY will be running a 3 Arm Pancreatic Phase II cancer trial mentioned in messagel #158 on the iHub ONCY board.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=47671946&txt2find=arm
From the RBC Capital Markets presentation in March 2010<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.>
Nice to finally see the Phase II Reo + Low Dosage Radiation results finally released which showed near 100% effectiveness in stabilizing these terminal cancer patients. There a several Phase IIs reporting data this year so it should be an exciting 6-9 months.
The key trial that should drive a partnership will be the Phase II NSCLC interim data release sometime this year.
onco_investor
Oncolytics ready for final step with Reolysin
(Note the new details of partnership plans by geographic region with Western EU and US being first. What is expected to drive partnership I believe is NSCLC RAS+ results due later this tear. Dr Thompson expects that a partnership should happen in the next year timeframe. Also initial Phase III first 80 patients enrollment is hoped to be by Christmas and initial results are expected by mid-2011)
May 18, 2010 by leonardzehr BioTuesday.ca
http://biotuesday.ca/2010/05/18/oncolytics-ready-for-final-step-with-reolysin/
After a 10-year journey, Oncolytics Biotech (TSX:ONC (2.81 ?0.00%); NASDAQ:ONCY ) is ready to take the final clinical step with its sole Reolysin drug as a treatment for a broad range of cancers.
“Our product has really shown a breadth of activity in a wide variety of cancers that we had hoped it would way back when we started out,” CEO Dr. Brad Thompson said in an exclusive interview with BioTuesday.ca. “It doesn’t matter what kind of drug combination we use or the amount of radiation, we typically get a clinical benefit no matter what the indication is, which is honestly pretty remarkable.”
Since 2000, when Reolysin first entered the clinic, Oncolytics has enrolled some 330 patients in multiple Phase 1 and 2 studies. “When we lump all indications together, you see this pattern, where people have a three-in-four chance of stabilizing or having a tumour regress fairly significantly. And an even higher percentage in metastatic lesions,” he adds.
The company is now gearing up to start its first Phase 3 pivotal study with Reolysin in patients with advanced head and neck cancer at 25 centres in Britain and the U.S., under a special protocol assessment from the FDA, with plans to expand to Belgium, for multijurisdictional approval in Europe and Canada.
Reolysin will be tested in combination with two chemotherapy drugs, paclitaxel and carboplatin, versus chemotherapy alone in a two-stage clinical trial. The first stage is designed to enrol 80 patients. The second stage is adaptive, and designed to enrol between 100 and 400 patients, with the most probable statistical enrolment now being 200 patients, Dr. Thompson explains.
The company expects to complete enrolment of 80 patients by this Christmas and release some initial data next spring or summer, he adds. The primary endpoint is overall survival, with key secondary endpoints including progression free survival, response rate and duration of response, as well as safety.
The U.S. National Cancer Institute estimates that 48,000 people in the U.S. alone contracted head and neck cancer in 2009 and that 11,260 died. European incidence and mortality are substantially higher than in the U.S., standing at 140,000 new cases each year and 69,000 deaths.
The decision to pursue a Phase 3 trial in advanced head and neck cancer followed positive results in mid-stage testing in Britain, combining Reolysin with paclitaxel and carboplatin, where the company demonstrated an overall response rate of 42% and a total clinical benefit rate of 74%. The company is currently conducting a confirmatory Phase 2 trial in the U.S. with patients having the same disease.
So what gives Reolysin such high marks?
Reolysin is a formulation of human reovirus, an acronym for respiratory enteric orphan virus. While the reovirus occurs naturally in nature, it is not known to cause any disease in humans. Its cancer-killing link comes from its ability to reproduce in various cancer cells that have an activated Ras pathway, one of the most important genetic defects leading to cancer.
In normal cells, the Ras pathway is turned off and the reovirus is unable to reproduce, creating few consequences for normal cells. Not so in cancer cells though, where an activated Ras pathway leads to a constant barrage of uncontrolled growth signals.
The company estimates that at least five million new patients a year will develop cancers with Ras involvement.
Dr. Thompson acknowledges that Reolysin works better in combination with chemotherapy or radiation than it does as a monotherapy, even though animal studies generated a strong response rate when Reolysin was used alone. “When we first started doing monotherapy in humans, the response rate dropped in half,” he recalls.
Further research found that by ablating the immune system with chemotherapy or radiation, channels opened in the cell wall of tumour cells, reducing the pressure within the cell. That allows the reovirus easy access into the cell, where it reproduces and kills the cancer cell. As cell death occurs, thousands of virus particles are released to infect surrounding cancer cells. This cycle of infection, replication and cell death is believed to be repeated until there are no longer any tumour cells carrying an activated Ras pathway.
ASCO Abstracts released Thursday May 20th 6PM
The abstracts for "General Poster Sessions" (including the one for the Phase I/II UK H&N Reolysin Trial) will be publicly released on ASCO.org on Thursday, May 20, at 6:00 PM (EDT).
http://chicago2010.asco.org/Abstracts/2010Abstracts.aspx
The recurrent ovarian cancer Reolysin Trial poster, and the Phase II Ras+ NSCLC Reolysin poster, will not be released until the presentation day of these "Trials in Progress Poster Session" presentations (Mon June 7).
I'm not sure what to make of the poster vs oral observation but I have been thinking the same thoughts. Might make a good question for the AGM. I believe the deadline for submission of the presentation to ASCO is rather early January if I remember so the trial status at that point is used so it might be early, updated data will be presented at the conference.
We shall find out in due course. ONCY/ONC is certainly not attracting any positive trading volume. I hope this changes very soon as we are a weekend away from the AGM. Im hopeful that there will be a positive news announcement between now and the AGM next week. I would be thrilled if it was start of enrollment of the Phase III.
Release of ASCO abstracts happens May 20th - Final H&N data from UK
The NSCLC poster at ASCO is June 7th - This one is the key one in my mind. Brad has stated that there are potential partners interested more in the NSCLC trial results than the H&N but Im hopeful they both will be PPS movers when publicly released.
3 Major Events in the next month. Should be exciting.
ASCO 2010 Posters Listed for Reovirus-ONCY
Greetings to the board, nice job Dew. How do we think ASCO will go for ONCY this year?
http://meetingplanner.asco.org/
Search Keyword - Reovirus
Developmental Therapeutics - Experimental Therapeutics
Monday, June 7 at 8:00 AM - 12:00 PM
S Hall A2
#3080: A phase I/II study of oncolytic reovirus plus carboplatin/ paclitaxel in patients with advanced solid cancers with emphasis on squamous cell carcinoma of the head and neck (SCCHN).
Eleni M Karapanagiotou
Clinical Trials, Special Session - Trials in Progress Poster Session
Monday, June 7 at 8:00 AM - 12:00 PM
S Hall A2
#TPS253: Phase I/II trial of reovirus serotype 3-Dearing strain in patients with recurrent ovarian cancer.
David E. Cohn, MD
#TPS292: Phase II study of reovirus with paclitaxel (P) and carboplatin (C) in patients with metastatic non-small cell lung cancer (NSCLC) who have Kras or EGFR-activated tumors.
Elaine Tat Lam
Interim Results?
ASCO 2010 Posters Listed for Reovirus
The Phase II H&N trial data being presented is from the trial that led to the pivotal Phase III trial Oncolytics is getting ready to announce start of enrolment any day now.
The NSCLC data will most likely be interim data but could be very compelling... I cant wait for these results to be made public.
http://meetingplanner.asco.org/
Search Keyword - Reovirus
Developmental Therapeutics - Experimental Therapeutics
Monday, June 7 at 8:00 AM - 12:00 PM
S Hall A2
#3080: A phase I/II study of oncolytic reovirus plus carboplatin/ paclitaxel in patients with advanced solid cancers with emphasis on squamous cell carcinoma of the head and neck (SCCHN).
Eleni M Karapanagiotou
Trials in Progress Poster Session
Clinical Trials, Special Session
Monday, June 7 at 8:00 AM - 12:00 PM
S Hall A2
#TPS253: Phase I/II trial of reovirus serotype 3-Dearing strain in patients with recurrent ovarian cancer.
Dr. Elaine Lam
#TPS292: Phase II study of reovirus with paclitaxel (P) and carboplatin (C) in patients with metastatic non-small cell lung cancer (NSCLC) who have Kras or EGFR-activated tumors.
Phase II Head and Neck - UK
Phase II Study of Intravenous Administration of a Wild-Type Reovirus (REOLYSIN®) in Combination With Paclitaxel and Carboplatin in Patients With Platinum-Refractory Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck.
http://www.oncolyticsbiotech.com/clinicaltrial_REO_011_Phase_II.html
Dr. Karapanagiotou was the first author in a poster presentation on the H&N trial in Nov 09. she was listed as affiliated with Royal Marsden. It appears that Dr. Karapanagiotou and Dr. Harrington have collaborated for years
Phase 1/2 NCI sponsored Ovarian Cancer trial at Ohio State Univ
A Phase 1/2 Study of Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) (NSC 729968) in Patients With Ovarian, Primary Peritoneal and Fallopian Tube Carcinoma
http://www.oncolyticsbiotech.com/clinicaltrial013.html
Elaine Lam. The Ohio State University Department of Internal Medicine, Columbus, OH. Current Position: Fellow in Hem Onc at OSU
Noteworthy Accomplishments: Elaine received an award for the ASCO/AACR "Methods in Clinical Cancer Research: workshop award in Vail, CO in August 2009 based on her work on our study exploring the role or Reolysin in Pancreatic Cancer.
Phase II NSCLC with K-RAS or EGFR-activated tumors
http://www.oncolyticsbiotech.com/clinicaltrial_REO_016.html
Phase II Study of Intravenous Administration of Reovirus Serotype 3 - Dearing Strain (REOLYSIN®) in Combination With Paclitaxel and Carboplatin in Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer Who Have KRAS or EGFR Activated Tumors
The primary objectives of the Phase II trial are to determine the objective response rate of REOLYSIN® in combination with paclitaxel and carboplatin in patients with metastatic or recurrent NSCLC with K-RAS or EGFR-activated tumours, and to measure progression-free survival at 6 months. The secondary objectives are to determine the median survival and duration of progression-free survival in patients, and to evaluate the safety and tolerability of REOLYSIN® in combination with paclitaxel and carboplatin in this patient population.
The Principal Investigator is Dr. Miguel Villalona-Calero, Professor, Division of Hematology/Oncology and Department of Internal Medicine and Pharmacology at The Ohio State University Comprehensive Cancer Center.
The abstracts for "General Poster Sessions" (including the one for the Phase I/II UK H&N Reolysin Trial) will be publicly released on ASCO.org on Thursday, May 20, at 6:00 PM (EDT).
http://chicago2010.asco.org/Abstracts/2010Abstracts.aspx
The recurrent ovarian cancer Reolysin Trial poster, and the Phase II Ras+ NSCLC Reolysin poster, will not be released until the presentation day of these "Trials in Progress Poster Session" presentations (Mon June 7).
Reovirus Activates Human Innate Immune Cell Killing of Colorectal Metastases in Vitro
Metastatic Colorectal Trial REO-013
Scheduled to be published at the 9th World Congress of the International Hepato-Pancreato- Biliary Association, to be presented by Robert Adair (part of Alan Melcher's team in Leeds UK) on Mon April 19, 2010. at 14:30 local time in Buenos Aires
http://www.ihpba-ba2010.com/scientific-programme/free-papers-sessions
REO-013 Details from Oncolytics website
http://www.oncolyticsbiotech.com/clinicaltrial_REO_013.html
"The trial (REO 013) is an open-label, non-randomized, single centre study of REOLYSIN® given intravenously to patients for five consecutive days in advance of their scheduled operations to remove colorectal cancer deposits metastatic to the liver. Patients will comprise two groups receiving REOLYSIN®, either at an early (21 to 10 days) or late time point (less than 10 days) before surgical resection. After surgery, the tumour and surrounding liver tissue will be assessed for viral status and anti-tumour effects."
Stay Tuned... details Monday! Thanks to RJC for uncovering this one.
Reovirus successfully purges multiple myeloma ex vivo and does not affect human CD34+ cell engraftment in a murine transplantation model – AACR 2010 Abstract #396
http://media.integratir.com/T.ONC/ppt/396_Thirukkumaran_MM.pdf
Research at the University of Alberta covers the utility of reovirus in treating hematological malignancies.
The investigators concluded that the sensitivity of reovirus towards multiple myeloma and its lack of effect on human stem cells highlight the potential of reovirus as an ex vivo purging agent during autologous hematopoietic stem cell transplants for multiple myeloma.
The poster is scheduled to be presented on Sunday, April 18, 2010.
Reolysin in combo with irinotecan shows synergistic anticancer activity in colorectal cancer cell lines – AACR 2010 Abstract #1773
http://media.integratir.com/T.ONC/ppt/1773_Sanjay_Colorectal_irinotecan.pdf
Research at the Ludwig Institute of Cancer Research in Melbourne Australia shows synergistic anticancer activity in colorectal cancer cell lines," covers research done in vitro into a novel therapeutic approach for treating patients with colorectal cancer tumors that harbor a mutation in the Kras oncogene that have failed first line therapy.
The investigators found that when REOLYSIN was combined with irinotecan, there was evidence of synergistic cytotoxicity in seven of eight tested cell lines and concluded that the combination of REOLYSIN and irinotecan is synergistic in colorectal cancer cell lines, including those with Kras mutation, and is worthy of exploration in human patients.
The poster is scheduled to be presented on Monday, April 19, 2010.
Reovirus replication in ovarian and peritoneal tumors after intravenous administration – AACR 2010 Abstract #2594
http://media.integratir.com/T.ONC/ppt/2594_Villalona_NCI.pdf
covers correlative results from a Phase 1/2 study with reovirus, sponsored by the National Cancer Institute under its Clinical Trials Agreement with Oncolytics, in patients with ovarian, primary peritoneal and fallopian tube carcinoma.
The results provide evidence of viral targeting and replication in peritoneal and ovarian cancer cells after intravenous administration of reovirus to patients.
The poster is scheduled to be presented on Monday, April 19, 2010.
Molecular pathways associated with Reolysin and gemcitabine synergy in ras-mutated human HCT116 cells – AACR 2010 Abstract #1646
http://media.integratir.com/T.ONC/ppt/1646_M_Lane_Colorectal_Gem.pdf
Work done by the Albert Einstein College of Medicine
covers work done to better understand the mechanisms associated with the cytotoxic synergies in this combined approach.
The investigators concluded that the top three canonical pathways significantly affected by the combination treatment were interferon signaling, antigen presentation and the protein ubiquitination pathways.
These data suggest that the combination of gemcitabine and REOLYSIN stimulates the immune system to increase surveillance/recognition of cancer cells.
The poster is scheduled to be presented on Monday, April 19, 2010.
Greenville Sun Article/Facebook news story
http://www.greenevillesun.com/story/308827
Source: The Greeneville Sun
Published: 11:27 AM, 03/31/2010 Last updated: 11:44 AM, 03/31/2010
BY LISA WARREN
STAFF WRITER
Todd Clendenon, a Greeneville man, whose battle with cancer recently became widely known through Facebook, received word Tuesday evening that he has been accepted into a clinical drug trial.
According to Joshua Stone, a family friend and creator of the Facebook page about Clendenon's situation, Clendenon was told by research physicians at the University of Texas' Cancer Therapy and Research Center, in San Antonio, that he would be accepted into the clinical trial to test a new drug that is awaiting approval from the Food and Drug Administration (FDA.)
Clendenon, 28, was diagnosed with squamous cell carcinoma of the mouth about two years ago.
He and his wife, Barbara, are the parents of two young children, a daughter, Madison, 7, and a son, Benjamin, 9 months.
Most recently, Clendenon has undergone treatment at the University of Tennessee Medical Center in Knoxville.
However, he was told that the cancer has spread to his lungs, which, according to Stone, made him eligible for this clinical trial study.
The drug, which was developed by Oncolytics Biotech, Inc., is being tested in clinical trials at research centers in San Antonio and New York City, Stone said.
Stone said that Clendenon was initially told by the research physicians in San Antonio that he would not be eligible for the clinical trial because the size of his tumor was larger than allowed under the pre-determined criteria for the study.
However, Clendenon was advised by Stone's father, Greeneville physician Dr. Mike Stone, to go to San Antonio for further evaluation by the physicians there.
Clendenon traveled to San Antonio last week and underwent the additional testing, which confirmed that the size of the tumor did not meet the criteria for the study.
However, the physicians said that the company that developed the drug could give final approval to his acceptance in the study.
Stone said that his father, Dr. Mike Stone, who is Clendenon's primary care phyisician, contacted the CEO of Oncolytics Biotech, Inc., and explained to him Clendenon's medical condition. The CEO agreed to discuss the situation and make a final determination.
After three hours of deliberation, Stone said, the biotech company agreed to accept Clendenon into its clinical drug trial.
The Clendenons received word last Tuesday evening about the decision.
Clendenon is scheduled to start the clinical trial treatment on Monday.
The clinical trial is a combination gene therapy and conventional medicine therapy, phase two study of the newly-developed drug Reolysin.
It is used in combination with paclitaxel and carboplatin in patients with head and neck carcinoma, according to the Web site clinicaltrials.gov/ct2/show/NCToo753038.
Debbie Overacker, Clendenon's mother who is with him in San Antonio, said this morning that the treatment may require eight sessions of treatment, each session given over two to three weeks at a time.
She said that her son has said that "he is a tool in the hands of God," and that he appreciates all of the prayers and support that he is receiving from everyone.
For more information and stories, see today's edition of The Greeneville Sun.
+
http://www2.tricities.com/tri/news/local/article/facebook_helps_save_a_life/43837/
Facebook story on the same patient.
In Battle Against Lung Cancer, Investigators Eye Oncolytic Virus Therapy
http://www.newswise.com/articles/in-battle-against-lung-cancer-investigators-eye-oncolytic-virus-therapy
Released: 4/2/2010 1:00 PM EDT
Source: Cancer Therapy & Research Center (CTRC) at the University of Texas Health Science Center at San Antonio
Newswise — A virus that destroys cancer cells but leaves normal cells unharmed may offer hope to those affected by squamous cell carcinoma of the lungs (SCC lung cancer), according to investigators from the Cancer Therapy & Research Center (CTRC) at the University of Texas Health Science Center at San Antonio. The CTRC has started patient enrollment in a US Phase 2 clinical trial using intravenous administration of REOLYSIN® in combination with carboplatin and paclitaxel in patients with SCC lung cancer.
REOLYSIN is an experimental treatment derived from a common virus called the reovirus. REOLYSIN directly kills many types of cancer cells and works synergistically with many approved chemotherapies and radiation.
When the reovirus enters a cancer cell, it produces thousands of copies of itself, causing the cell to burst. But the reovirus can replicate only in cancer cells with mutations along a signaling pathway in the cell called the Ras pathway, while leaving normal cells unharmed. Approximately two-thirds of all human cancers express this particular mutation and are therefore a potential target for REOLYSIN treatment.
“The study offers new hope for this group of patients with lung cancer,” said Dr. Alain C. Mita, a medical oncologist and assistant professor of medicine at the CTRC at the UT Health Science Center.
The trial (REO 021) is a single arm, open-label, Phase 2 study of REOLYSIN given intravenously with paclitaxel and carboplatin every three weeks. Up to 55 patients are expected to be treated in this trial. Eligible patients include those with metastatic stage IIIB, stage IV, or recurrent squamous cell carcinoma of the lung who are chemotherapy naïve for their metastatic or recurrent cancer.
“There are significant similarities between SCC lung and SCC head and neck cancers,” said Dr. Karl Mettinger, Chief Medical Officer for Calgary-based Oncolytics Biotech, the company behind REOLYSIN. “We are observing clinical benefit in a majority of our SCC head and neck cancer patients treated to date. We have seen clinical responses in metastatic lung lesions with REOLYSIN whether used as a monotherapy or in combination with paclitaxel and carboplatin, and are hopeful that this treatment combination will provide similar benefit to SCC lung cancer patients.”
According to Dr. Matt Coffey, COO of Oncolytics, “This clinical study expands our interests into a variety of lung cancers. In addition to this study, we are also enrolling patients with non-small cell lung cancer (NSCLC) with K-RAS or EGFR-activated tumors in a US Phase 2 clinical trial using REOLYSIN in combination with paclitaxel and carboplatin.”
The primary objective of the Phase 2 trial is to assess the antitumor effect of the treatment regimen in the study population in terms of objective response rates. The secondary objectives are to assess progression-free survival and overall survival for the treatment regimen in the study population, to determine the proportion of patients receiving the above treatment who are alive and free of disease progression at six months, and to assess the safety and tolerability of the treatment regimen in the study population.
This trial is part of a broad preclinical and clinical collaboration with the CTRC that will involve up to five, open-label, Phase 2 studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications. Earlier this year, Oncolytics received a letter of approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers.
The American Cancer Society estimates that in 2009, there were approximately 219,440 new cases of lung cancer. Approximately 85% of all lung cancers are classified as NSCLC (non-squamous cell lung cancer); squamous cell carcinomas account for 25-30% of all lung cancers. Lung cancer is by far the leading cause of cancer death among both men and women. There were an estimated 159,000 deaths from lung cancer in 2009, accounting for around 28% of all cancer deaths. More people die of lung cancer than of colon, breast and prostate cancers combined. For more information about SCC lung cancer, please go to www.cancer.org. Patients who would like information about the CTRC trial can call the patient referral line at 210-450-5798.
Description
A virus that destroys cancer cells but leaves normal cells unharmed may offer hope to those affected by squamous cell carcinoma of the lungs (SCC lung cancer), according to investigators from the Cancer Therapy & Research Center (CTRC) at the University of Texas Health Science Center at San Antonio.
According to Dr. Alain C. Mita, a medical oncologist and assistant professor of medicine at the CTRC at the UT Health Science Center, this novel study using reoviruses offers new hope for patients affected by squamous cell carcinoma of the lungs.
BioScience World - Building a cancer treatment from a virus: Matt Coffey Chief Operating Officer Oncolytics Biotech Inc.
http://www.biotechfocus.com/BuildingacancertreatmentfromavirusMattCoffeyChiefOperatingOfficerOncolyticsBiotechInc
Compiled by Shawn Lawrence
Chemotherapy as any cancer patient will tell you isn’t for the faint of heart but it can kill many forms of cancer. Some forms of chemotherapy, originally
discovered as a cancer treatment almost 70 years ago, are still routinely prescribed for most types of the disease.
The treatment works by targeting fast-growing cells, like those typically found in rapidly growing tumours. But while chemotherapy can shrink tumours, they often grow back and become resistant, or refractory to the treatment.
To combat this resistance, chemotherapy is now often used in combination with other treatments that have different mechanisms for attacking and killing cancer cells.
Doctors must be cautious when combining treatments to ensure that the regimen doesn’t become too toxic for patients to tolerate. The goal is to introduce drugs that can be used synergistically with chemotherapy to not only extend life, but to improve quality of life while undergoing treatment.
One such complimentary drug may be Reolysin, a naturally occurring reovirus developed by Calgary-based Oncolytics Biotech Inc. The treatment is a virus that doesn’t make humans sick, preferentially it replicates in cancer cells with an activated RAS pathway and spares normal cells. The cancer’s Oncolytics has targeted with this reovirus are mostly solid-tumour cancers that have a tendency to spread or metastasize.
Matt Coffey, chief operating officer and co-founder of Oncolytics Biotech Inc. has been with the company every step of the way, from the initial discovery of the product at the bench, to the launch of the company with the help of CEO Brad Thompson, and now as the company prepares to launch its Phase III trial. The planned human trial will assess the intravenous administration of Reolysin with the chemotherapy combination of paclitaxel and carboplatin vs. chemotherapy alone.
The unique part explains Coffey is that it is a cancer treatment built on a virus with no known associated disease.
“Reoviruses are found everywhere in nature and have been isolated from untreated sewage, river and stagnant waters.
Exposure to reovirus is common in humans, with half of all children by the age of 12 having been exposed, so it’s not something new. In terms of the actual product, it is a double-stranded RNA non-enveloped virus that is able to replicate in the cytoplasm and therefore does not integrate into the cell’s DNA,” he explains. “Approximately two thirds of all cancers (including breast, ovarian and small-cell lung cancer cancers that have metastasized, or spread to other parts of the body) have an activated RAS pathway so the possibilities of Reolysin’s efficacy are endless.”
Strong synergy with existing therapies
Thus far, Reolysin has demonstrated impressive results in both clinical trials on its own, and in combination with certain chemotherapeutics. In preclinical studies of a wide variety of cancer cell lines, investigators found that when used together, reovirus and chemotherapy resulted in more efficient anti cancer activity, than when each agent was used on its own. Additionally, in human trials the combination therapy has performed well in refractory head and neck cancer patients, leading to tumour shrinkage without adverse side effects. With these clinical results, a solid manufacturing program and numerous patents approved, Oncolytics is well positioned to launch the final stage of its development of Reolysin.
“The results are so promising that we announced plans to test the treatment combination in a late-stage, pivotal trial in patients with platinum-failed head and neck cancers later this year,” Coffey said adding that Non-small cell lung cancer (NLCLC) is another potential target for this treatment combination. Oncolytics has already started patient treatment in a U.S. Phase II combination Reolysin and chemotherapy trial. The Cancer Therapy & Research Center at the University of Texas Health Science Centre-a big proponent of oncolytic viruses-committed this year to funding up to five, Phase II clinical trials using the combination against a variety of advanced cancers.
Moreover, the company recently reached its biggest milestone to date, an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) on the design of the previously mentioned Phase III trial. The agreement is the first of its kind for an intravenously administered oncolytic virus. Shares in the company have soared since the human trial was given the ok to move forward. This is the however the most expensive phase and most important stage, and makes Coffey’s evolving role with the company all the more important. For both Coffey and the company it is the culmination of a long and arduous ten year journey.
“The thing is we weren’t trying to come up with a cancer therapeutic, it was more just following up on an interesting observation with a type two pathogen, looking at basic biology and we got lucky.
I remember thinking to myself when we made the discovery, wow, that’s interesting. It was very akin to Isaac Asimov’s belief that the most exciting phrase to hear in science, the one that heralds new discoveries, isn’t ‘eureka’, but rather ‘that’s funny’. Then the discovery was published in Science and everyone was asking where was I going to be doing my post doc, and I said well actually what I think I’m going to do is start this company. A lot of my thesis advisors felt I was giving up a golden opportunity, ‘you have a set future in academia and you’re just sort of stepping out into the great unknown, why are you doing that?”
Making the leap into the world of business and leaving behind the sheltered life of academia was only the first step; the learning curve was even more intense.
“Just trying to play catch-up in terms of the legal side of things, the regulatory side, the clinical aspects and the politics as chief scientific officer was pretty difficult. As we moved away from the basic research, I moved away from that role into the chief operating officer role and now we’re at a point that while we continue to do a lot of basic research and collaborations with universities throughout the world, things are now much more directed. I’m becoming more involved in the manufacturing aspects, defending and creating new intellectual property, interacting with potential partners at an operations level. It’s a move more towards the actual commercial aspect in the same way the product is inching closer to commercialization,” he said.
For the company, there has also been a few challenges and hurdles along the way.
Among the bigger challenges was overcoming regulators natural biases and fears against the thought of using a virus as a therapeutic.
“For ten years, we were the ugly baby of the industry, and many were concerned with the nature of the agent. You can imagine going to regulators and saying we want to give an unattenuated completely replication competent infectious disease causing vector to the terminally ill. But it was dogged determination more than anything else that helped us overcome the naysayer’s that said it wouldn’t work, you’ll never get a patent, you’ll never get a Phase 1 and you’ll never be able to use the product systemically. But here we are with SPA approval, and now everyone is saying, oh I knew it, I knew it would work. So it’s nice to see the change in the attitude,” he said.
His faith in the product has only grown stronger with every new positive result and as such he is proud to have taken what was once called “an interesting research project” to the brink of the commercialization “You don’t step into a Phase 3 unless you think you’re going to be successful. You don’t go there, you don’t want to risk patients unless you’re absolutely confident it’s going to work, and every indication is it will, I’m very firm in my belief that not just our product but this whole area of using viruses to target malignancy is going to be the next step in the treatment of not just cancer, but human disease as a whole,” said Coffey.
Its taken ten years to get to the point where people have embraced the science, and for Coffey it’s been worth the wait.
“To have taken something from an idea all the way through hundreds of patients, through the manufacturing to create an intellectual property state around it, to have it listed on Toronto and the NASDAQ.
We are the only group that has ever received special protocol assessment (SPA) for a systemically used virus. This is as far out on the edge as you can possibly be, so it’s been a gas. I think 5 or 6 years from now I’ll take a look back and think how did we even do it?”
Thanks to Hellacious_too
My 300 share buy at .20 bid filled at .14 at 1:43pm
Very strange stuff!
eTrade shows .17 x .1999
Fat chance of that LOL, maybe at .35!
Your welcome!