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That is vague. I was hoping for a Georgia update soon and another one around the time of ASCO. I think there should be some very compelling Georgia data available now...but I admit that the data will be more mature and even more interesting by the end of May.
There is a lot more news to come on a variety of topics. e.g.Cotara,Bavi-solid tumours,HCV/HIV,Duke/Haynes,AVID,DTRA contracts,etc.etc.
The company has admitted that the trial results are even better than they expected.
1. The safety data is far superior to Avastin.
2. The ORR is significantly better than Avastin.
3. The Complete Responses are a pleasant and encouraging surprise and far superior to Avastin(it is not hard to beat O).
4.The next Georgia study results (whenever they are released)should reveal better TTP than Avastin and begin to show survival benefits which are sadly missing from Avastin use.
I think that many are surprised that unarmed Bavi is as effective as it has turned out to be. "Safe and effective" will ensure a lot of big pharma interest. And as I never fail to remind people, Avastin sales are $3 Billion this year.
flg,You are correct...a partnering deal will solve all the problems because of the up-front money, milestone payments and royalty payments. And AVID revenues will add to the profitability. AVID is a great asset...both now and in the future. But if the next release of Georgia data is as good as earlier data and remains so and at the time of ASCO, they should be able to do a partnership deal...or be bought out sometime this year. They know that as the data gets better,with more patients,and longer survival, the offers get better.
AVID revenues are growing dramatically and the March CC may tell us more. But there are also the Two Big Elephants in the room that have very large potential.
1. Elephant #1.The potential of a large government anti-viral stocking program. How big will this be? I would guess that it would be very large.
2. Elephant #2.If there is a partnership for Bavi-cancer signed this year I would expect all future Bavi-cancer production to be recognized as revenue. And a big pharma would want a big supply for a number of phase III studies in a number of indications. And once Bavi-cancer sales ramp up into the billions of dollars what will the AVID revenues be?
Both of these Elephants assume the on-going success of Bavi-cancer and Bavi-viral trials. That is my expectation and underlying assumption. Good luck to us all.
I expect the Georgia results next Wednesday....if the current practice of Wednesday releases continues. But I don't really care which day or which week! When it comes the Georgia data will give us a picture of more patients over a longer timeframe than we have seen so far. When it does come I can hardly wait to see mojojo's chart...a picture is worth a thousand words!
We can expect the safety data to continue to be better than Avastin. We can expect the ORR to be better than Avastin. HOW WILL THE TTP AND SURVIVAL DATA COMPARE TO AVASTIN? That is the big question and while we may have reason to expect better results than Avastin the Georgia data will be the first to confirm this. Just keep in mind that Avastin has $3 billion in sales this year....and if Bavi continues to be superior....and the company gets a partnership royalty rate of 33%....what do you think the PPHM share price will be?
I expect partnership(s)or buyout in 2009. The data so far is just too good to be ignored by big pharma. Will it continue to be good? The next release from Georgia may answer that question in regard to Bavi-cancer. Will Duke/Haynes provoke some action in the Bavi-viral area? We will soon see that data as well.
I was hoping they would release the data from the studies just as they have done it with the Georgia data last. It is the longest running study with the best opportunity for us to see a trend as to just what the TTP and survival figures will be. I would also like to see some more data from the Bavi-solid tumour study(to see what other targets to go after) and an update on the Cotara studies.
In the anti-viral area I look forward to the results of the HCV/HIV repeat dose study and of course, the Duke/Haynes publication. I also wouldn't be at all surprised to see some expansion of the DTRA contact and some more good news out of AVID.
I expect a lot of this news in the next 2 months...and then a lot of updates around the time of ASCO (May29-June 2). And could there be a Cotara or a 2C3 partnership announced before there is a Bavi partnership? The longer they carry out the 3 Bavi-cancer studies the better the survival data, the better the partnership terms for Bavi-cancer. And when might there be a Bavi-viral contract in the HIV or malaria indications? Maybe Bill Gates knows...but I don't.
And a attractive buy-out offer would spoil all the fun of waiting to look at the various partnering options. Whether it is partnering or buy-out I expect a bidding war.
I expect the Georgia data was held back because it is the longest study with the BEST results. The longer these studies go the better the results! This seems to be a very logical way to arrange the news releases. I am very keen to see the results as we may get some TTP data.....and some sense of survival trends. It is all good!
Wildhorses,
I know that we don't yet know everything that there is to know about Bavi...or as Donald Rumsfeld would say "There are things we don't know and things we don't know we don't know etc.,etc." But I agree with you that if I had to make a choice as to which drug combination either I or my wife would take I would I would BEG to have the Bavi conbination.
What impresses me so far is the safety profile(and we have to remember that unarmed Bavi has been given both to cancer and viral patients with minimal side-effects)AND the unexpected COMPLETE RESPONSES. WOW!... does that ever give a patient hope! Just to know that out of the very small numbers in the trials so far there are already several CR's. And I expect a very significant increase in length of survival....another point where the current SOC(Avastin+chemo)provides very little benefit.
I look forward to the use of Bavi with other targeted drugs which have very little toxicity. Cancer treatment is still very primitive. People will look back and remark, "You mean to say they actually poisoned people and destroyed their immune systems to treat cancer!" Bavi is part of the future.
With Avastin you get no increased survival.... no complete responses....and a list of adverse events that curl your hair! Bavi already has some complete responses and a much better adverse event profile. Bavi already is producing better ORR rates....and the Georgia data could give us a look at some better TTP data. It doesn't take a genius to predict better survival data! Big pharma is looking at all the data and you can expect some behind the scenes action on the partnership or buy-out front over the rest of this year,until a deal is done.This is all behind the scenes so we won't know about a deal before it is done. But I would be very surprised if there are not several Big pharmas ready to bid against each other because Bavi,unarmed and armed, will be a huge revenue producer for whoever gets hold of it. All IMHO.
The NEJM article clearly says that the chemo alone RR was 21% and the Avastin+chemo RR was 37%...whereas the NCI article says that the chemo alone RR was 14% and the Avastin+chemo RR was 28%.It gets curiouser and curiouser. However one thing is certain. The Bavi result of 50% RR one-third way through the treatment is outstanding(and likely to get better as it did in the Georgia study!).
cj,JBM's blog says there was a 37% response rate for those on Avastin plus chemo....but when I went to the NCI website news release it says that there was a 14% response rate for those on chemo alone and a 28% reponse rate for those on Avastin plus chemo. If this figure is correct the Bavi results are even more startling.
1. chemo alone response rate....14%
2. Avastin+chemo response rate..28%
3. Bavi+chemo response rate.....50%(1/3 way through treatment)
Could you or JBM clarify where the 37% figure came from?
Bavi is both safe and effective. But what is becoming clear is that it is SAFER and MORE EFFECTIVE than Avastin. The ORR rate is better than Avastin. And in the next release from Georgia (later this week or next week?)we may have some data showing the TTP is significantly better than Avastin. By this summer we should see a trend to better overall survival than Avastin offers. Big pharma are getting all the data and you can bet that their partnership and/or buy-out offers are getting better and better.
Meanwhile there should also be some good news on the Bavi-viral front soon as well as good news from AVID and Cotara.
In regard to DNA and Roche being interested in Bavi. In the TMCnews release of February 4 Peregine's Executive Director of Clinical and Regulatory Affairs Joe Shan is quoted as saying, "Because its mechanism is separate from the VEGF pathway in which Avastin works, there may actually be some synergies at some point in the future."
This is good business to keep the door open for a deal with Roche or DNA...and maybe even good science!
Big pharma will like these early results..These are excellent ORR rates and will probably get better as the full course of treatment occurs(as happened in Georgia). We could get the Georgia update later this week or next Wednesday. It will be interesting to see the TTP data from that study. So far the ORR rate is better than Avastin...and I fully expect the TTP rate will also be better than Avastin. Then the really exciting thing will be to see the survival data. Avastin's weakest points are the safety data and the survival data. So far the Bavi safety data is far better than Avastin.
The final and crowning issue will be Bavi's survival data. The CR's and higher ORR rates are a good indication that Bavi will leave Avastin in the dust! Remember that Avastin sales will exceed $3 billion in 2009. All the big pharma (including Roche and DNA) will want a partnership or buy-out deal to get their hands on Bavi! Do you know what a 33% royalty rate on $3 billion in sales would mean to the PPHM share price?
If Bavi is superior to Avastin in safety and equal in TTP and survival...then Avastin sales would suffer. However if Bavi is superior to Avastin in safety AND also superior in TTP and survival then Avastin sales are in huge trouble in the future. I'm sure one of the big pharma watching the Bavi data closely is Roche! The next news releases from India and Georgia will be very important to the future of PPHM.
If Bavi is better than Avastin then I would expect there to be be either a partnership or a buy-out at a high share price in 2009. Avastin sales in 2009 will exceed $3 billion.
So far we have seen that Bavi has a significantly better ORR than Avastin and a significantly better safety profile.The next releases should give us an indication if the TTP is better....and maybe some indication if the median survival is going to be better.
Even if the TTP and survival rates are only EQUAL to Avastin the superior safety profile would make Bavi a succesful candidate.
Big pharma will get all this data...and will start to make some significant offers this year IMHO. I would prefer to see a partnership...but if the data is really good I would not be surprised to see some buy-out offers. BP has a lot of money and they all need piplines. Bavi, unarmed and armed, has a lot of potential.(Multi-billions in sales) We simply need to wait for the results later this month to see if the results are bad, merely good or are outstanding.
I'm not defending Benjamin because the "interview" seemed to be very poorly done...and he did not get a chance to edit it. But if you take seriously his view that
1. There can be sales in three years.
2. The company has cash for one year.
3. A deal could give the company another $30-40 million.
That would provide enough cash for the 3 years before there are sales, however there are always three parts to a partnership.
1. Cash up front. ($30-40 million is low but enough!)
2. Milestone payments. These are usually in the hundreds of millions...plenty to work on several second generation drugs.
3. Royalty payments. This is the biggest issue. I would be very pleased to see a small up front payment ($50-100 million)and moderate milestone payments ($200-300 million) and a HIGH ROYALTY RATE. This would be on a sliding scale in the 20-40% range depending on sales. As the sales will be in the billions this is the biggest issue. If Bavi turns out to be 50-100% better than Avastin (paticularly in over-all survival!) without any of the horrible side-effects the sales will be in the multi-billions.
Or maybe if Charlie Stein called it would go like this....
"Good morning.Mr. Weldon's office."
"Good morning, is Bill in."
"Who is this?"
"This is Charlie Stein from the Peregrine message board."
"Oh Charlie, after last night you promised to call."
"Yes,yes my dear, I'll call you at home this evening...but now could you put me through to Bill."
"Oh yes, yes Charlie, anything you say."
***
etc.
A Hard Sell? Avastin As A Breast Cancer Med
By Ed Silverman // December 3rd, 2007 // 1:59 pm
The biotech is hoping to win recommendation from an FDA panel on Wednesday to peddle Avastin as a treatment for breast cancer. But data posted on the FDA web site today suggests this may be a hard sell. The med failed to help breast cancer patients live longer and had serious side effects, including deaths, according to the FDA. Wall Street reacted by beating up Genentech stock on very heavy volume.
The drug, which is currently approved as a part of a regimen for treating colon and non-small cell lung cancer, did slow the spread of metastatic breast cancer by an extra 5.5 months when used chemo, compared with patients who received only chemo. But Avastin patients had a 20 percent increase in serious side effects, and the med didn’t show a statistically significant ability to extend lives, according to the FDA. Patients receiving Avastin lived an average of 1.7 months longer than those given only chemo, but that wasn’t statistically significant. (This is the briefing document).
Of the 363 patients in the study, 1.7 percent who took Avastin died from side effects, compared with none of the 348 people on chemo, the FDA medical reviewers wrote. Those side effects included high blood pressure, blood clots and heart attack. A separate clinical trial of patients who took Avastin after relapsing on chemo found the med failed to slow cancer or extend lives, the FDA noted. UPDATE: An advocacy group, Breast Cancer Action, is urging the FDA to reject approval because the evidence makes “sick women guinea pigs.” (see below).
Genentech is seeking FDA approval of Avastin as a breast-cancer treatment in combination with Taxol in women with advanced breast cancer who previously haven’t received chemo. But any benefit in slowing cancer “must be weighed against the increased toxicity,” the FDA reviewers wrote.
“The market is expecting the FDA’s expert panel to vote negatively against Avastin in metastatic breast cancer, which could wipe $1 billion off estimates” for additional revenue, Martin Voegtli, an analyst at Sal Oppenheim in Zurich, tells Bloomberg News.
The FDA does not love progression-free survival as a primary endpoint… (and) there’s still the issue of whether tumor shrinkage equates with prolonged surivival,” write Jim Reddoch, an analyst with Friedman Billings Ramsey, in an investor note this afternoon. “Avastin in breast cancer is important, because it’s the next growth for the drug. Odds are the panel is fine, but there’s definitely more downside than upside.”
Meanwhile, Breast Cancer Action is urging the FDA to deny approval if no benefit in overall survival is shown. “To date, the data Genentech has made available indicate that Avastin delays time to progression of metastatic disease, but there is no indication that it improves patient survival. The use of surrogate end points like time to progression, which are used as an early indicator of a drug’s effectiveness, are meaningless unless that end point is shown to correlate with overall survival,” the group writes in an e-mail.
“BCA looks forward to the day when we can say with confidence that a drug is effective at increasing survival for women with metastatic breast cancer. However, approving Avastin based on the kind of evidence currently available makes very sick women guinea pigs for evaluating the long-term effects of the drug, as well as its dangers,” says BCA executive director Barbara Brenner.
Spanky the quote is in " " and CAPITAL LETTERS and the rest of that sentence. The rest of the paragraph are my remarks. I am very excited by his comments. It does not matter what happens on this board. It does not even matter what happens to the share price day to day. All stocks have their ups and downs. With the company "IN DISCUSSIONS WITH PROBABLY EVERY BIG PHARMA COMPANY OUT THERE..."the results in the clinic will be what drive the stock price. That is what big pharma is looking at. I expect more good news out of Georgia and India on Bavi and Cotara. And more good news out of Duke and AVID and DTRA. When big pharma start to make offers on partnerships or a buy-out I expect to see a bidding war. They all want pipelines and Bavi-cancer and Bavi-viral will each be multi-billion dollar sellers. Meanwhile the rapidly growing AVID revenues alone warrant the current stock price.
The quote of the week is from CFO Paul Lytle. The TMC news item quotes him as saying "Peregrine IS IN DISCUSSIONS WITH PROBABLY EVERY BIG PHARMA COMPANY OUT THERE. "....and he added that the company believes data from its ongoing Phase II programs will increase the value of bavituximab. Big pharma is watching closely. They all need piplines. They all have a lot of cash(multi-billions). I expect partnerships or buy-out offers this calendar year. And I expect the phase II results to get better and better as they look at Median TTP and median survival in comparison to Avastin. Only time will tell but the phase II results expected in the next few weeks should be very encouraging to future-oriented medium to long term investors. All new investors should do their own dd..it is very worthwhile.
ASCO words "...occasionally of major significance..." may very well apply to Bavi results IMHO. What do you think?
Can you imagine how much off-label use there will be for Bavi in both the cancer and viral uses once it gets approved for one indication. Safety has NOT been an issue and caring doctors will want to extend its use to patients who have no hope from other drugs. If you were suffering from a terminal cancer or viral disease wouldn't you want to try Bavi? In some of these trials there are heavily pre-treated patients who have no hope apart from Bavi. Let's hope it is fast tracked in both cancer and viral applications. And let's hope the price is reasonable so all patients can afford it!
Could this indicate an out of court settlement?
February is "early in the new year". Next week is February. And I have always expected news in February. I expect both Duke/Haynes and Indian and Georgian data next month. Big Pharma is watching. Patience. In the next 4 weeks there will be a lot of news! Meanwhile I wonder if BOT is hearing anything? I like his posts because he is generally correct about the direction of events....while as uncertain about timing as the rest of us!
I can't find where management said there would be news in January. "Early in the new year" certainly includes February and I do expect news in February. There will certainly be the Duke/Haynes publication and I hope either before or after that release we will hear from Georgia, India and some U.S. sites. After that there will be a March CC, AACR in April and ASCO in May, and another round of data in June-July. And of course there could be Cotara news and partnerships in Cotara,Bavi-cancer or Bavi-virus any time. If the news is good the share price will go up and up and up. If it is bad it will go...you know. But there will be a lot of news in the first 6 months of this year and even over the summer. By this time in 2010 I expect this to be either a very high priced stock or to have been bought up by Big Pharma. I hope it is still a going concern as I think shareholders will do better in the long run with several very big partnerships as opposed to a buy-out.
There is confusion about interim data news in that Ren Benjamin asked in the last CC about about an update in the "first half of CY'09" and received a positive answer. And the phrase "early in the new year" was used several times. And of course ASCO in May 29-June 2 will be an opportunity for an update as will AACR in April 18-22 and the March 15 CC. Could there be a number of interim updates?
I think BOT thought there would be a January news release. I think King said "early next year" which could mean January, February or March if he meant the calender year. But maybe BOT could give us an update. He can only tell us what he hears...what happens is not up to him...so I don't blame him if things are delayed. Things change...and delays are common in the biotech world. And finally there could be news in the next few days!!!
Does'nt this look like someone is doing a professional job of accumulation without dramatically forcing the price up? If I had big bucks and wanted to accumulate this stock this is how I would do it. Remember that the news is expected "early this year". Any time in February would be "early this year"!
Are U.S. stem cell stocks moving? This past week SSS.TSX-V moved from 4.5 cents to 13.5 cents this morning. This company does not use embryonic stem cells but stimulates a persons own stem cells to repair the brain after stroke or trauma. Its trials have been on hold because of some European problem with EPO...the share price increase could be because of general stem cell interest or because the clinical hold(self imposed) is now over.
DISCLOSURE: I bought a bunch at 3.5 cents a few weeks ago.
Is news expected in January or by the middle of February? Is there any reason to think that the recent move is due to a leak? I was expecting news in February...and I expect it to be very good. But if it is out sooner I won't complain. With good news from both the cancer and viral sides and increasing business for Avid, I would look for a buy-out rather than a partnership. This company is incredibly undervalued...a cancer parnership might cost $500 million...and a viral partnership might cost $500 million...and there are so many potential indications...so why not just try to buy the whole company? Personally I think shareholders would do better with partnerships because I think the long term potential is huge. But I expect some hostile takeover attempts in this dreary market.
There will be a lot of news out of SSS in the next little while.They are starting the phase IIb trial in the stroke indication very soon with trials in a number of countries. They will also start a phase II in traumatic brain injury. And the results from a comparator MS study should be out soon. They are using the resident adult brain stem cells to help the brain repair itself. They have been talking to big pharma in Europe, Israel and North America about partnering. They expect the 140 patient stroke phase IIb to be completed by the end of 2008.
The goats are in MICHIGAN not CANADA. Obama has given Canada enough problems..we don't need the sick goat rap!
For those interested in stroke the SSS:TSX-V results webcast is up.
You can get it at http://audability.com/AudabilityAdmin/Clients/StemCellTherapeutics/10572_226200810000PM/primary.aspx?Event_ID=572
Still trying to understand SSS stroke results. The company claims that the 100% NIHSS score improvement of 4 points or greater would normally be seen in 30% of patients...and the 62% Barthel Index score of 95-100 indicates an "excellent" outcome. Those seem to be very good results in a small study. It is interesting that they treat in a 24-48 hour window...much better than the 3 hour window for tPA...albeit for a different indication. I look forward to next Tuesday's audio webcast. I hope it works out as I would like it to be available if I ever suffer a stroke.
Any stroke experts on this board? This release came out this morning ... and there will be more data released at the International Stroke Conference that is beginning today in New Orleans...and the webcast by Dr.Steven Cramer next Tuesday.
CALGARY, ALBERTA, Feb 20, 2008 (Marketwire via COMTEX News Network) --
Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE:SSS) is pleased to announce favorable results from the investigator led BETAS (Beta-hCG + Erythropoietin in Acute Stroke), Phase IIa, open label, safety trial conducted at the University of California, Irvine and Hoag Presbyterian Memorial Hospital, Newport Beach, CA. This trial is the first to test the safety of NTx(TM)-265 in patients suffering acute ischemic stroke and to conduct a preliminary assessment of functional recovery in this patient population.
Results from the BETAS trial showed no serious adverse events related to NTx(TM)-265 in the 13 patients enrolled. Of these, 8 patients completed the 90 day assessment term and each of them showed a clinically relevant improvement in their National Institutes of Health Stroke Scale (NIHSS) score of 4 points or greater. Patients entered the trial with NIHSS scores ranging from 6-19 (moderate to severe). In these patients, average baseline NIHSS was 8.3 plus/minus 4.1 (mean plus/minus SD) and improved in 8 of 8 patients to an average day 90 NIHSS of 2.5 plus/minus 1.8, an improvement in NIHSS score of 5.8 plus/minus 2.5 points. Five of these 8 patients had a day 90 Barthel Index score of 95-100 (out of 100); consistent with excellent outcome. Specific assessments of neurological recovery affected by NTx(TM)-265 were also favorable, including the Arm Motor Fugl-Meyer Scale, an arm motor recovery assessment; Trailmaking A test, a measure of cognitive function; and measures of neglect and aphasia. Further, the drug regimen decreased the size of the infarct in 6 out of 8 patients overall, given a mean decrement in all 8 of about 10%.
Dr. Alan Moore, President and CEO of SCT, commented as follows:
"The encouraging results from this trial are consistent with results previously reported as an interim analysis on April 10, 2007 and suggest great promise for our NTx(TM)-265 treatment for stroke, but interpretation of results from the BETAS trial is limited by small patient sample size and absence of a placebo control group. Nevertheless, these results represent an important first step in defining the safety of the NTx(TM)-265 regimen in patients with acute neurologic injury. Equally promising is early evidence in a small group of patients that consistent recovery of motor, cognitive and visual function may occur as a result of NTx(TM)-265 neuro-regenerative therapy for stroke."
The next development step for SCT is to build upon the promising results from the BETAS clinical trial with the initiation of the REGENESIS proof of concept study. REGENESIS is a Phase IIb prospective, randomized, double-blind, placebo controlled study of NTx(TM)-265: human Chorionic Gonadotropin (hCG) and epoetin alfa (EPO) in acute ischemic stroke patients. The REGENESIS trial will be conducted at approximately 15-20 Canadian clinical trial centers and aims to enroll 134 patients in 2008.
The BETAS clinical data will be formally presented at the International Stroke Conference in New Orleans, LA, February 20-22, 2008. SCT will also be hosting a live audio webcast to review the results with Dr. Steven Cramer on Tuesday February 26, 2008.
Stem Cell Therapeutics Conference Call
SCT will be hosting a live audio webcast on Tuesday, February 26, 2008 at 1:00 PM EST to review the BETAS Phase IIa results with Dr. Steven Cramer. Participants may listen via audio webcast, accessible through the Company's website at www.stemcellthera.com or via telephone. The telephone conference number is 416-849-2698 or toll-free at 1-866-400-2270.
About NTx(TM)-265: NTx(TM)-265 is a therapeutic regimen of two approved and clinically well-defined drugs, human Chorionic Gonadotropin (hCG) and Erythropoietin (EPO), targeting the treatment of stroke. The objective of the regimen is to stimulate the growth and differentiation of new neurons to replace the brain cells that were lost or damaged by the stroke. Animal studies have shown a significant recovery in motor function after receiving the NTx(TM)-265 regimen 24-48 hours post stroke. Similar results have been found in SCT's Phase IIa BETAS safety trial, as announced on April 10, 2007. SCT has initiated a multi-centre, double-blind, placebo-controlled Phase IIb REGENESIS study for NTx(TM)-265 with primary endpoints of efficacy.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE:SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells. The company's programs aim to repair neurological function lost due to disease or injury. The company's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases.
For further information on Stem Cell Therapeutics Corp., visit www.stemcellthera.com.
These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
SOURCE: Stem Cell Therapeutics Corp.
Stem Cell Therapeutics Corp. Alan Moore, PhD President and CEO (403) 245-5495 ext.224 Email: amoore@stemcellthera.com Stem Cell Therapeutics Corp. Chloe Douglas-Crampton Manager, Investor Relations (403) 245-5495 ext. 221 Email: crampton@stemcellthera.com Website: www.stemcellthera.com
Yes Vancouver is great with fresh snow...and here is a Celtic blessing for us all.
LORD BLESS THE POOR,
LORD BLESS THE SICK,
AND ALL THE HUMAN RACE.
LORD BLESS OUR FOOD,
LORD BLESS OUR DRINK,
AND ALL OUR HOMES EMBRACE.
Stem Cell Therapeutics Corp. Supports the Canadian endMS Research Conference
09:00 EST Tuesday, December 11, 2007
CALGARY, ALBERTA--(Marketwire - Dec. 11, 2007) - Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE:SSS) is pleased to announce that Drs. Trina Johnson, Wee Yong and Samuel Weiss will be presenting preliminary results from a study of the pro-inflammatory effects of prolactin in a mouse model of Multiple Sclerosis (MS) at the Canadian endMS Research Conference held in Banff, Alberta, from December 10th through the 13th. The work of Drs. Johnson, Yong and Weiss explores prolactin's role as a therapy in acute and chronic central nervous system (CNS) disease settings.
Drs. Weiss and Yong recently published exciting preliminary work on the regenerative effects of prolactin in the Journal of Neuroscience, February 21, 2007 entitled; 'White Matter Plasticity and Enhanced Remyelination in the Maternal CNS'. Interestingly, the study confirmed that pregnant mice have an enhanced ability to remyelinate white matter lesions, explaining the observation that in mammals MS symptoms can subside during pregnancy. This study was novel in that it identified for the first time that prolactin acts to increase the generation of new myelin-forming oligodendrocyte precursor cells, and to increase the number of myelinated axons in the pregnant murine central nervous system (CNS). Most importantly, the finding that prolactin could increase white matter plasticity suggests a striking ability to repair demyelination and identifies prolactin as a potential therapeutic agent.
"We at SCT have been and will continue to support the cutting edge research conducted in the laboratories of Drs. Weiss and Yong," said Dr. Alan Moore, President and CEO of SCT. "We hope to take their work from concept stage to patients with diseases such as MS where there currently is no cure."
The intellectual property encompassing the discovery of prolactin's effect in the CNS by Drs. Weiss and Yong falls within SCT's patent portfolio.
About the Canadian endMS Research Conference: The key goals for this conference are to highlight the wide range of research on MS conducted across Canada, and to introduce the endMS Research & Training Network, a newly developed national initiative funded by the MS Scientific Research Foundation and the MS Society of Canada. The Network is aimed at attracting and retaining the best and brightest minds to train and work in MS research, in order to accelerate the pace of discovery and, ultimately, end this disease.
Key Facts about Multiple Sclerosis (MS):
( http://www.mssociety.ca/en/information/default.htm)
- Canadians have one of the highest rates of multiple sclerosis in the world.
- MS is the most common neurological disease affecting young adults in Canada.
- Every day, three more people in Canada are diagnosed with MS.
- Women are more than three times as likely to develop MS as men.
- MS can cause loss of balance, impaired speech, extreme fatigue, double vision and paralysis.
- MS was first identified and described by a French neurologist, Dr. Jean-Martin Charcot, in 1868.
- We don't know what causes MS but researchers are closer to finding the answer.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE:SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells. The company's programs aim to repair neurological function lost due to disease or injury. The company's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases.
These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
Stem Cell Therapeutics Corp. Supports the Canadian endMS Research Conference
09:00 EST Tuesday, December 11, 2007
CALGARY, ALBERTA--(Marketwire - Dec. 11, 2007) - Stem Cell Therapeutics Corp. ("SCT") (TSX VENTURE:SSS) is pleased to announce that Drs. Trina Johnson, Wee Yong and Samuel Weiss will be presenting preliminary results from a study of the pro-inflammatory effects of prolactin in a mouse model of Multiple Sclerosis (MS) at the Canadian endMS Research Conference held in Banff, Alberta, from December 10th through the 13th. The work of Drs. Johnson, Yong and Weiss explores prolactin's role as a therapy in acute and chronic central nervous system (CNS) disease settings.
Drs. Weiss and Yong recently published exciting preliminary work on the regenerative effects of prolactin in the Journal of Neuroscience, February 21, 2007 entitled; 'White Matter Plasticity and Enhanced Remyelination in the Maternal CNS'. Interestingly, the study confirmed that pregnant mice have an enhanced ability to remyelinate white matter lesions, explaining the observation that in mammals MS symptoms can subside during pregnancy. This study was novel in that it identified for the first time that prolactin acts to increase the generation of new myelin-forming oligodendrocyte precursor cells, and to increase the number of myelinated axons in the pregnant murine central nervous system (CNS). Most importantly, the finding that prolactin could increase white matter plasticity suggests a striking ability to repair demyelination and identifies prolactin as a potential therapeutic agent.
"We at SCT have been and will continue to support the cutting edge research conducted in the laboratories of Drs. Weiss and Yong," said Dr. Alan Moore, President and CEO of SCT. "We hope to take their work from concept stage to patients with diseases such as MS where there currently is no cure."
The intellectual property encompassing the discovery of prolactin's effect in the CNS by Drs. Weiss and Yong falls within SCT's patent portfolio.
About the Canadian endMS Research Conference: The key goals for this conference are to highlight the wide range of research on MS conducted across Canada, and to introduce the endMS Research & Training Network, a newly developed national initiative funded by the MS Scientific Research Foundation and the MS Society of Canada. The Network is aimed at attracting and retaining the best and brightest minds to train and work in MS research, in order to accelerate the pace of discovery and, ultimately, end this disease.
Key Facts about Multiple Sclerosis (MS):
( http://www.mssociety.ca/en/information/default.htm)
- Canadians have one of the highest rates of multiple sclerosis in the world.
- MS is the most common neurological disease affecting young adults in Canada.
- Every day, three more people in Canada are diagnosed with MS.
- Women are more than three times as likely to develop MS as men.
- MS can cause loss of balance, impaired speech, extreme fatigue, double vision and paralysis.
- MS was first identified and described by a French neurologist, Dr. Jean-Martin Charcot, in 1868.
- We don't know what causes MS but researchers are closer to finding the answer.
About Stem Cell Therapeutics Corp.: Stem Cell Therapeutics Corp. is a Canadian public biotechnology company (TSX VENTURE:SSS) focused on the development and commercialization of drug-based therapies to treat central nervous system diseases. SCT is a leader in the development of therapies that utilize drugs to stimulate a patient's own resident stem cells. The company's programs aim to repair neurological function lost due to disease or injury. The company's extensive patent portfolio of owned and licensed intellectual property supports the potential expansion into future clinical programs in numerous neurological diseases.
These securities have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any state, and may not be offered or sold within the United States or to, or for the account or benefit of U.S. persons unless an applicable exemption from U.S. registration requirements is available.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
FOR FURTHER INFORMATION PLEASE CONTACT:
Stem Cell Therapeutics Corp.Alan Moore, PhDPresident and CEO(403) 245-5495 ext.224Email: amoore@stemcellthera.com
or
Stem Cell Therapeutics Corp.Chloe Douglas-CramptonManager, Investor Relations(403) 245-5495 ext. 221Email: crampton@stemcellthera.comWebsite: www.stemcellthera.com
The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
Here is more about the 2007/2008 Life Sciences Competition Winners
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"Canada's Top 10 is a powerful brand that attracted the attention of top-tier US venture capitalists and investment bankers in 2006. At the Canadian Consulate General, we are pleased to host Canada's Top 10 Life Sciences Investment Forum in January 2007, and we are confident that the relationships forged will lead to results for the Canadian companies."
Marie-Louise Hannan, Consul (Investment) and Trade Commissioner, Consulate General of Canada
“This competition is a unique snapshot of emerging life science companies in Canada. It showcases great technologies and entrepreneurs that are ready for prime-time investing.”
Maha Katabi, Vice-President, Life Sciences, Ventures West (Canada’s Top 10 Earley Stage Jury Member)
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Artenga Inc. (Ottawa, Ontario)
www.artegna.com
Artenga’s medical device will make cancer drugs dramatically more effective to serve an unmet need: drug-resistant tumour treatment. Revenue potential is one hundred million dollars per year. Competitive advantages have been validated by world-leading doctors and researchers (Sunnybrook Health Sciences Centre and the Ontario Veterinary College) and initial animal tests were successful. Market entry is advanced colon cancer. Doctors are demanding improved drug effectiveness with minimal side effects. The Artenga device will be supplied by established channel partners and work within existing clinical practices. The cancers most suitable for treatment are colon, pancreatic, liver, ovarian, and breast. A Health Canada pre-market evaluation has been done and three patent applications filed. Artenga’s experienced medical industry team has raised over $500,000.00 including an Ontario Centers of Excellence Accelerator investment. A U.S. company will serve as Artenga’s sales representative for the medical research market. Profitability will be attained in three years.
Bioniche Life Sciences Inc. (Belleville, Ontario)
www.bioniche.com
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company that develops, manufactures, and markets proprietary products for human and animal health markets worldwide. The fully-integrated Company employs 195 people and has three operating business units: Human Health, Animal Health, and Food Safety. Corporate headquarters are located in Belleville, Ontario, Canada. The Company’s human health business unit has research and production facilities in Montréal, Québec, Canada. The Animal Health business unit has product development and manufacturing facilities in Belleville, marketing and production facilities in Athens, Georgia, USA; Pullman, Washington, USA; and Armidale, Australia; as well as a sales and marketing office in Ireland.
The Company has several areas of strategic focus, including the development of its proprietary technologies for bladder cancer and other cancers; a cattle vaccine to help reduce E. coli O157:H7 contamination of food, water and the environment; technologies to improve livestock reproduction; and technologies that could replace the use of antibiotics in livestock. The Company’s existing animal health business is global in scope.
DiaMedica (Winnipeg, Manitoba)
www.diamedica.com
DiaMedica Inc. is a biotechnology company developing novel treatments for all stages of Type 2 diabetes based on a newly corroborated mechanism. Rather than treating the symptoms, we address the cause of Type 2 diabetes with multiple points of intervention. The novel mechanism is based on a nerve signal from the liver which we have shown may be responsible for 50 to 65% of total glucose uptake normally attributed to insulin action. The science is based on the work of our CSO, Dr. Wayne Lautt, who was nominated for the prestigious CIHR Michael Smith prize in Canadian health research. Our lead candidate, DM-71, has recently completed a successful phase II clinical trial while a second drug candidate, DM-83, has just completed a positive pre-clinical study. These results indicate that we have discovered a new drug class to treat type 2 diabetes.
Genesis Genomics Inc. (Thunder Bay, Ontario)
www.genesisgenomics.com
Genesis Genomics Inc. (“GGI”), founded in 2001, is a world leader in the research of mitochondria DNA (“mtDNA”) biomarkers and the development of non-invasive, molecular diagnostic tests targeted at the early detection of cancers and other diseases. Our tests are designed to be life changing applications for both physicians and patients. Our research and development is focused on identifying disease at the time of its ‘genesis’ – the point in time when the mtDNA begins to mutate – which is a significant improvement from the present day, late stage diagnosis based on clinical symptoms.
MedGenesis Therapeutix Inc. (Victoria, British Columbia)
www.med-genesis.com
MedGenesis Therapeutix Inc. is an emerging biopharmaceutical company focused on developing and commercializing innovative and life enhancing treatments for patients with serious central nervous system (“CNS”) disease. MedGenesis’ strategy and business model is built upon the following key components:
Developing therapeutics for CNS indications with high unmet medical need including brain cancer, intractable epilepsy and Parkinson’s Disease.
Use of a patented, state-of the-art convection-enhanced delivery (“CED”) platform to overcome the most significant limitations of systemic treatment strategies for serious CNS disease.
Led by Dr. Erich Mohr, a recognized expert in neurodegenerative disorders, the management team consists of highly experienced global biopharmaceutical executives with proven track records of simultaneously developing multiple drug candidates.
Norgen Biotek Corp. (Thorold, Ontario)
www.norgenbiotek.com
Norgen Biotek is an innovative, steadily growing privately-held Canadian biotechnology company similar to Bio-Rad, Invitrogen, Qiagen and Ambion, focusing on innovative products for DNA, RNA and protein purification, clean-up and concentration. The purification of these macromolecules is the first step in hundreds of applications fuelling discovery for the genomics, proteomics, and molecular diagnostics markets. Norgen has a unique one platform technology with many applications based on a proprietary resin/matrix. The company holds more than a dozen issued and pending patents. Norgen has successfully exploited part of their extensive IP and has developed and is currently manufacturing over 40 sample preparation products with excellent differentiation. These products address a billion dollar a year market. Currently, Norgen is financing the marketing of its products organically, which is a slow process. To capitalize on our leadership position in product quality and capture significant market share, Norgen is seeking investments to accelerate its growth strategy.
ProDrive Systems (Montreal, Quebec)
www.prodrivesystems.com
ProDrive Systems contains three distinct but related divisions, a product division - ProDrive Systems, a dealer division - High Speed Service in the United States and Canada and a distribution company - Handpiece Experts. ProDrive has completed the design and development of the ProDrive Upgrade Turbine and handpiece and is now manufacturing product. After obtaining Health Canada certification and FDA certification, ProDrive products are now being commercialized in North America. In February 2007, ProDrive announced the acquisition of High Speed Service, North America’s fastest growing and most dynamic handpiece service group. With over 90 dealers across North America and access to over 10,000 trusting customers, High Speed Service will help launch ProDrive as a major player in a world market valued at USD $3.2B. ProDrive is planning a series of other dealer acquisitions to support a larger scale reach into the North American market.
Rapid Laboratory Microsystems Inc. (Kitchener, Ontario)
www.rapidlabs.com
Rapid Laboratory Microsystems, Inc. (RapidLabs™) is a Canadian private biotechnology company centered in commercializing science in healthcare. The company’s corporate offices and research facilities are located at Grand River Hospital in Kitchener, Ontario. RapidLabs’ Microbiology and Analytical Chemistry Laboratories are equipped to focus on applying new science to accelerate the treatment of infection and disease.
The Company’s initial application will revolutionize antibiotic susceptibility testing (AST) and bacterial identification (ID) activities in clinical microbiology. RapidLabs’ breakthrough, patented technology measures microbial respiration rather than growth, which dramatically improves the time to result, and provides for greater efficiency in the microbiology lab. RapidLabs has completed the development of “Astec”, an initial manual system to demonstrate the company’s novel ability to deliver Real-Time Bacterial Identification and Antibiotic Susceptibility Testing.
The company has also demonstrated that its proprietary science is effective across a clinically relevant set of bacterial species and antibiotics. Additionally, research has been initiated into applying the RapidLabs technology for optimizing the treatment of cancer.
REPLICor Inc. (Laval, Quebec)
www.replicor.com
REPLICor is developing a broad-spectrum antiviral drug called REP 9C which has the broadest spectrum of antiviral activity ever described for a single chemical entity. REP 9C is active against many important viruses including hepatitis C and influenza and is highly effective in treating several viral infections in animals. The Company has established multiple research collaborations with leaders in the antiviral field in North America, Europe, Asia and Australia. The main focus of the Company is to develop its first-in-class entry inhibitor for the treatment of patients with hepatitis C and to prevent re-infection following liver transplantation. The corporate plan is to demonstrate that REP 9C will be active and safe when used in humans. Once this proof of principle is reached, we believe that the Company will be in a favorable position to either execute a rapid exit strategy or enter into an alliance with a large pharmaceutical company.
Stem Cell Therapeutics Corp. (Calgary, Alberta)
www.stemcellthera.com
Stem Cell Therapeutics Corp. (SCT) is a Canadian public biotechnology company (TSXV: SSS) focused on the development and commercialization of drug-based therapies to treat CNS diseases. SCT develops therapies that utilize drugs to stimulate a patient's own resident stem cells with an aim to restore neurological function lost due to disease or injury. The lead SCT program, NTx™-265, works to increase the number of neural stem cells located in the brain of a patient suffering from a recent stroke, and promotes the differentiation of these newly formed cells into functional neurons. This is anticipated to provide benefit to the patient through the replacement of the brain cells that were lost or damaged by the stroke. SCT is enrolling patients in a Phase IIa clinical trial in the United States and Canada in order to investigate the safety of NTx™-265, and plans to initiate a Phase IIb study late in 2007.
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