This was better than the interim analysis of 26.2 months and also much longer than the 18.9 months for patients on the current standard of care, Taxotere plus prednisone. Last week, Provenge, the prostate immunotherapy from Dendreon (DNDN), was recommended by the FDA advisory panel after providing a 4.5 month increase in median survival. GVAX is now in a Phase III trial. The news sent Cell Genesys on a 32% climb; it rose $1.39 to $5.70.
Theravance (THRX) said that two one-daily asthma drugs in Phase IIb trials each caused a response equal to twice-daily salmeterol. The tests were part of a collaboration between Theravance and GlaxoSmithKline (GSK), which is developing a combination inhaled drug, comprised of a LABA and a corticosteroid, for asthma and chronic obstructive pulmonary disease. Because the GSK-discovered drug performed better, it will be the focus of development, while the Theravance drug will be kept as a backup. This means it is unlikely GSK will exercise an option to buy a 50% stake in Theravance at $54.25 per share. Instead, Theravance will pay GSK $220 million upon approval of the GSK-discovered compound. Theravance dropped 96 cents to $28.74.
Repros Therapeutics (RPRX) announced that Proellex, an oral drug that relieves the symptoms of uterine fibroids, passed its Phase II test. Proellex reduced excessive menstrual bleeding, the endpoint of the test, by mean scores of 94% in the high-dose cohort. The drug did not have any effect on the size of the fibroids. Despite the positive report, Repros was off 9 cents at $10.49.
Opexa (OPXA) said its T-cell vaccine Tovaxin was safe and effective in a Phase I/II trial in patients with multiple sclerosis. In a 10-patient dose-escalation test, Tovaxin reduced the annualized rate of relapse by 90%. The patients were dosed weekly for 20 weeks and monitored for 32 weeks thereafter. Opexa is enrolling 150 patients into a year-long Phase IIb trial; 100 of the patients will receive Tovaxin in a less-frequent dosing regimen. The endpoint will be the cumulative number of gadolinium-enhancing lesions on T1-weighted MRI scans. Opexa gained 28%, moving up $1.16 to $5.31.
Ligand (LGND) was listed as being sharply lower, but most of the decline came because the stock is trading ex a $2.50 dividend, paid to shareholders because Ligand sold its pain drug Avinza and its cancer drugs last year. Taking the $2.50 dividend into account, the stock moved up 7 cents to $7.56.
Elan (ELN) and Transition Therapeutics [TTH.TO] of Canada received Fast Track designation from the FDA for their Alzheimer’s drug. The compound is currently in Phase I tests, with Phase II trials scheduled to begin before the end of the year. Elan was 31 cents higher at $13.67, and Transition moved up 16 cents to $1.80.
Biotech had a very positive day. The Centient Biotech 200™ rose 41 points to 3928, a gain of 1.06%. The S&P 500 was .93% higher and Nasdaq climbed 1.16%.