Missed on ONTY

Shares of ONTY gapped up this morning on positive preliminary results for Stimuvax, a lung cancer immunotherapy.

http://www.tradingmarkets.com/.site/news/TOP%20STORY/2383852/

Based on this article reporting positive results on breast cancer clinical trials, I contemplated purchasing some ONTY shares over the weekend. However, it soared over 30% this morning before I could get my buy order filled. I will hope for a pullback, as ONTY has as much, if not more upside potential than DNDN, the prostate cancer immunotherapy company we profited from back in April.

DNDN's Provenge had a 22.5% overall survival benefit above advanced prostate cancer (PC) patients on placebo, and patients on Provenge lived 4.1 months longer on average, which is significant considering late-stage PC life expectancies are short. Once approved by the FDA, which now appears likely, Provenge will extend the lives of many PC patients, and labeling will be extended to early-stage PC patients, further increasing the 90% success rate for that segment.

In June, ONTY announced a 17.3 month median survival benefit for Stage IIIB non-small cell lung cancer patients above those on placebo. With multiple shots on goal with Stimuvax (lung, breast, prostate, and colorectal cancers), and a healthy pipeline of other oncology drugs, ONTY shares have some serious long-term upside potential.

This is not a recommendation.

Disclosure: I have no position in ONTY, and a long position in DNDN.

Shares of DNDN halted in after hours trading

Dendreon, a Seattle-based biotech specializing in cancer immunotheraphy, will be announcing top-line results of a phase III clinical trial for Provenge tomorrow. The pivotal metric is whether patients with prostate cancer will have a 22% survival benefit from Provenge vs. the place control group.

An advisory panel gave a recommendation to the FDA of approval in 2007 based on a positive safety profile and promising interim survival benefits. But in a controversial move (especially for life-threatening oncology treatments), the FDA did not approve Provenge, seeking more results for this IMPACT clinical trial.

The results will be announced tomorrow in a conference call at 6 am PT. If Provenge meets its 22% survival benefit benchmark, the share price for DNDN will explode. If they miss their target, the share price could collapse to almost zero. Such is the life of a biotech microcap company.

If IMPACT proves effective, it could open the doors for immunotheraphy of other cancers, and could be a game-changer for oncological treatment. For investors and patients, let's hope this one is a winner.