Forty-eight hours ago, the market cap of Dendreon, (Nasdaq:DNDN) www.dendreon.com, fell squarely within the parameters of companies we profile in smallcapworld. Yesterday, the company kissed its small cap status goodbye, perhaps forever. That can happen when a closely watched drug shows extremely positive Phase 3 study results. Survival data of its Provenge® vaccine were significant and the Company plans to file for FDA approval by year’s end.
Provenge is a therapeutic vaccine that seeks to treat cancer by training the immune system to fight tumors. As AP medical writer Marilyn Marchione writes, “This is the second major study in which Provenge has shown a survival benefit, leading some scientists to its approval will lead to a new approach to fighting cancer beyond the surgery, radiation, hormones and chemotherapy used now.” http://finance.yahoo.com/news/Company-says-prostate-cancer-apf-14926596.html
Dendreon’s news provided a rare shine on what can be a drab, though vital, sector. But remember that prostate cancer is the second leading cause of cancer death to men in the U.S., responsible for 27,000 deaths a year. With 285,000 new diagnoses a year, the market requires various treatments because the cancer takes many different forms.
One relatively new approach is cryoablation, literally freezing the tumors to death. A new version of the therapy, called focal cryoablation or the “male lumpectomy,” targets only the cancer while sparing the gland’s healthy tissue. Irvine, CA-based Endocare (Nasdaq:ENDO, http://www.endocare.com), is the only publicly-traded medical device company to specialize in cryoablation. Another company, privately-held Galil Medical (http://www.galil-medical.com), also manufactures and sells a cryoablation device and the two companies have announced plans to merge under the name Endocare. The merger plan, announced in November 2008, is currently being reviewed by federal regulators.
A patient who opted for cryoablation discusses the procedure here: ( http://www.onemedplace.tv/play.php?vid=519). Combined, Endocare and Galil Medical treated approximately 10,000 prostate cases last year, but cryoablation also holds potential for use on liver, kidney and lung cancers.
Long Island’s Misonix (Nasdaq:MSON), www.misonix.com, markets a broad suite of medical devices that use ultrasound for various surgical and medical applications. Its Sonablate® 500 device is in Phase 3 trials. It seeks approval to do with heat what Endocare does with freezing. The device is known as a HIFU (High Intensity Focused Ultrasound) product and it causes very localized cell death by focusing the ultrasound beam in a targeted volume of tissue.
Isoray (NYSE Amex:ISR), www.isoray.com, of Richland, WA provides brachytherapy, which is the implantation of radioactive seeds into the prostate. Its Proxcelan™ seed is the first major advancement in brachytherapy in over twenty years. It is far less likely to cause collateral damage to surrounding tissue than its peers because it has a higher average energy, a key factor in how uniformly the radiation dose can be delivered throughout the prostate. It also has a shorter half-life than its peers, which limits the amount of seed implants as well as the duration and and severity of typical side effects associated with brachytherapy.
From freezing to heating and from surgery to ultrasound, the choices for prostate cancer treatment are many. San Francisco-based Medivation (Nasdaq:MDVN), www.medivation.net, is developing a drug for patients who appear to have run out of options, including castration. Castration-resistant prostate cancer (CRPC) is so classified because it is resistant to the last option of treatment one would receive; it is also more likely to spread to other organs. Its MDV3100 drug received promising study results of its own last week when early phase I/II safety tests in 30 men showed it was safe and might be shrinking tumors. http://www.reuters.com/article/marketsNews/idINN0748148820090407?rpc=44
The stock trades at $17.60, up from its 52 week low of $11.27 and down from its high of $34.10.