Cell Genesys Positive Prostate Cancer Study Data (CEGE, DNDN)
Cell Genesys, Inc. (NASDAQ: CEGE) has announced that the final data from the second of two Phase II clinical trials (G-0010) of GVAX immunotherapy for prostate cancer has been published in the online issue of Cancer. This is the publication of the American Cancer Society.
As a reminder, this company is somewhat after the same goal as Dendreon (NASDAQ: DNDN) in the fight to treat prostate cancer.
The results from this Cell Genesys multi-center trial showed an overall median survival of 35.0 months in the subset of patients who received a dose of GVAX immunotherapy for prostate cancer comparable to that currently being evaluated in the ongoing Phase 3 program. It also noted that these results were consistent with those observed in the first multi-center Phase II trial which indicated an overall median survival of 34.9 months in those patients who received a dose comparable to that being evaluated in the Phase III program.
The survival results from both Phase II clinical trials compare favorably to the previously published median survival for metastatic hormone-refractory prostate cancer patients treated with Taxotere® chemotherapy plus prednisone, the current standard of care for this patient population.
A copy of this article titled “Phase 1/2 Dose-Escalation Study of a GM-CSF-Secreting, Allogeneic Cellular Immunotherapy for Metastatic Hormone-Refractory Prostate Cancer” can be seen at the following URL:
http://www3.interscience.wiley.com/journal/120840830/abstract
As a result, the company notes that it is on track to complete enrollment of the second of the two ongoing Phase III trials, in the first half of 2009 and its expects to reach the number of events needed to trigger final analysis of the first of the two Phase III trials in the second half of 2009.
Much of this data seems to be reaffirming what has already been observed. But this stock has a huge short interest of more than 18.4 million shares and this has shares indicated about 5% higher in the immediate pre-market reaction.
Jon Ogg
July 22, 2008
Speculative Prostate Cancer Stocks On Ropes (DNDN, CEGE)
Investors have been warmed up to biotech stocks in recent weeks, but a trend is starting to emerge where investors want companies that are either very close to commercialization of a key product or one where there is a diversified portfolio of molecules and drug candidates with various indications. Cell Genesys, Inc. (NASDAQ: CEGE) and Dendreon Corp. (NASDAQ: DNDN) are two companies who had promising prostate cancer hopes in 2007, but they have gone to the wayside and today is not looking any better for the companies.
Cell Genesys Inc. (NASDAQ: CEGE) is seeing a very poor showing today. Its shares are down 12% to $2.63 and it hasn’t even traded its average daily volume of a normal trading day right after 2:30 PM EST. This is a low not seen since the end of March.
Last week we saw a shelf filing from Dendreon Corp. (NYSE: DNDN) allowing the company to raise up to $300 million for marketing and development of PROVENGE for prostate cancer (if and when it is approved). The stock has been holding up right under the $5.00 mark, but today the stock is now at a 5-day low at $4.85 and a low not seen since the end of March. There is likely a fear that a deal is coming much sooner rather than later as we have seen four-times normal volume.
The culprit here could be a published story in Proceedings of the National Academy of Sciences about lifestyle change studies of 30 men with “low risk prostate cancer” and the study found that many disease-promoting genes (including those associated with cancer, heart disease, and inflammation) were “downregulated” or “turned off” and the protective and disease-preventing genes were “upregulated” or “turned on.” For whatever it is worth, the study/article concludes “we’ve raised more questions than we’ve answered, and we need larger, longer-term studies.”
It is hard to imagine that a small university study would unseat these companies further, but we are talking about small cap questionable stocks.
Jon Ogg
June 18, 2008