Replies to post #7411 on Biotech Values

[DewDiligence]

Re: Additional color

>>Having worked in both the pharmaceutical industry (training sales reps on the medical aspects of drugs) and on the "front lines" in pharmacy, I understand how these companies market. If something is good, the hyperbole is unbounded. If the information is bad to marginal, the statements are positive, but subdued.<<

I could not agree more.

A case in point was GENR’s mid-2004 PR announcing the phase-2 results in non-small-cell lung cancer, which said how management and the clinicians were “encouraged” by the data. Yes, they were so greatly encouraged that they have done absolutely nothing to plan a follow-on study.

We saw essentially the same thing with Lomucin in cystic fibrosis. In October 2003, GENR announced in a PR that the data were encouraging, and cheerleaders such as ‘ridgerunner’ on the Yahoo board pumped the results hard. Yet a year and a half has now elapsed since the CF trial was completed and there has been no follow-up.

>>Also, claiming profit is a good thing<<

Like you, I made money on GENR (a lot of it --my largest-ever gain in the market) and I do not wish to give it back. Those still holding GENR could yet strike it big, but I do not like the odds.

In particular, I question whether the company will ever get the critical “209” trial fully enrolled now that Macugen is on the market. I also wonder about possible issues in the manufacturing of Squalamine that might derail the AMD program. That GENR steadfastly refuses to disclose details of the manufacturing does not help to allay such concerns.

Last but not least, a systemic approach to anti-angiogenic AMD treatment appears far less attractive today than it once appeared to be. Every other company pursuing the large AMD market has opted for a locally-administered treatment.

Putting this all together to the degree that can be done with the limited data that investors have access to, I now give Squalamine at most one chance in three of reaching the market before 2010.

[DewDiligence]

More “encouragement” from PTN

http://biz.yahoo.com/prnews/050208/nytu137_1.html

>>
…that the results showed improvements in both genital arousal and sexual desire in such a small study population are encouraging and warrant the continued investigation of PT-141 in women with FSD," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin Technologies.
<<

When they use the word “encouraging” in this context, you can be pretty sure the results were not statistically significant. (Of course, they weren’t really trying to achieve statistical significance (LOL).)

Apropos to rpi_in_wi’s post earlier today, companies could make life easier for investors if they would cut the BS and simply lay out the results. This trial was small, so failing to achieve statistical significance is not in itself a disaster. The problem is: from reading Palatin’s PR you cannot tell if the results were “encouraging” meaning not too bad, or “encouraging” meaning fuggetaboutit as in GENR’s Lomucin trial.

[DewDiligence]

Get a load of this press release:

[Australian Cancer Technology evidently does not understand the difference between “mean” and “median,” which does not exactly enhance the company’s credibility. Moreover, it’s disingenuous for them to report a doubling of median survival (they said “mean” but did not mean it, hehe) when the doubling is relative to an historical study rather than a randomized arm of the study in question.

That makes two strikes against these guys without doing any DD other than reading the press release.]

http://biz.yahoo.com/prnews/050208/nytu275_1.html

>>
Positive Phase I/II Results from Pancreatic Cancer Study Announced by Bioaccelerate Holdings Inc. and Australian Cancer Technology

Data Show Doubling of Mean Survival Time in Patients with Pancreatic Cancer Using RP101 with Chemotherapy Treatment

NEW YORK, Feb. 8 /PRNewswire-FirstCall/ -- Bioaccelerate Holdings Inc. (BACL.OB) and Australian Cancer Technology (AustCancer) (ASX: ACU - News), today announced results from an extended Phase I/II clinical study evaluating RP101 in combination with gemcitabine plus cisplatin for the treatment of metastatic pancreatic cancer. RP101 (bromovinyl deoxyuridine, or BVDU) is targeted at preventing cells from developing a resistance to chemotherapy. Bioaccelerate and AustCancer acquired the North American rights to RP101 from ResProtect GmbH in September 2004.

In an extended Phase I/II clinical study conducted by ResProtect in Germany, 13 patients with metastasized pancreatic cancer were treated with RP101 and gemcitabine plus cisplatin. Of the patients treated, nine had stage IV disease and four had stage III disease. Per treatment cycle, patients were given 125mg of RP101 four times per day for the first five days of treatment. The treatment was repeated ten days later. The regimen was repeated for up to six treatment cycles (1-6). For the treatment group, the 50% probability of survival was increased to an average of 15 months from an historic average of 7.5 months (p=0.008). The historical control was developed using a separate study of 15 patients with stage IV disease and 7 with stage III treated with gemcitabine and cisplatin (Heinemann et al., ASCO 2003, University Munchen). [Stating a p-value for a comparison like this is really bogus.] Ten out of the 13 patients lived or live longer than one year, and six of them are still alive. Additionally, time to tumor progression was increased to 7.5 months versus 4.75 months as seen in the Heinemann control group.

"The results of this study are encouraging and we are excited to be developing this promising drug candidate for the treatment of pancreatic cancer. We believe that RP101 can be useful in expanding the therapeutic window for chemotherapy, possibly extending survival while also improving the quality of life for pancreatic cancer patients," stated Dr. Nigel Rulewski, Senior Vice President of Bioaccelerate Holdings Inc. "Our partnership with AustCancer further confirms our commitment to developing products that address significant, underserved medical needs while simultaneously building value through investment in the early development of exciting technologies."

According to The American Cancer Society, about one out of four patients with cancer of the exocrine pancreas will live at least one year after the cancer is found. In the RP101 study, 10 out of 13 patients lived longer than one year. The group predicts that, in 2005, about 32,180 people in the U.S. will be diagnosed with pancreatic cancer and about 31,800 will die of the disease.

Patients undergoing repeated chemotherapy treatment can build a resistance to the chemotherapy's intended toxic effects and cancer cells continue to grow and spread during treatment. RP101 is intended as a co-treatment with cytostatic drugs to prevent the development of chemotherapy resistance, often noted as a significant challenge for oncologists. In preclinical studies, co- treatment of chemotherapy with RP101 prevented the decrease of apoptotic effects during the course of chemotherapy and reduced non-specific toxicity. In several different in vivo tumor models, the anti-tumor efficacy of chemotherapy was optimized, and toxic side effects were reduced.

In pancreas carcinoma cells, the oncogene STAT3 is over-expressed leading to the suppression of apoptotic (programmed cell death) responses. Additionally, treatment with gemcitabine leads to the over-expression of the DNA-repair gene APEX, commonly implicated in chemoresistance. RP101 has been shown to down-regulate STAT3 and APEX, in different tumor cell lines.

About Bioaccelerate Holdings Inc.

Bioaccelerate Holdings Inc. is a pharmaceutical development organization that seeks to acquire, develop and commercialize novel pharmaceutical compounds in an efficient, cost-effective way. Bioaccelerate uses its broad network of academic, industry and capital market relationships to expedite drug development and raise capital to create and fund its subsidiary companies, which are organized by vertical portfolios in five therapeutic areas: oncology, specialty pharmaceuticals, central nervous system disorders (CNS), cardiovascular disease and anti-infectives.

Bioaccelerate conducts its business directly and through its subsidiaries. The company holds majority equity interests in ten biopharmaceutical companies, three of which are public and holds minority interests in four biopharmaceutical companies, two of which are public. The company also holds a minority equity interest in a public nanotechnology company. Bioaccelerate strategy relies on its development network for research, clinical development and project management to guide early-stage compounds from the discovery process through to Phase II/III development where incremental value can be created. Bioaccelerate Holdings is quoted on the Over-The-Counter Bulletin Board under the symbol "BACL.OB". For more information on Bioaccelerate, visit the company's website at http://www.bioaccelerate.com .
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