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Biotech Stock Mailbag: Labopharm

Rexahn issued a press release last May announcing positive results of the phase II study of Zoraxel in erectile dysfunction. This is what the company said at that time:

"The study, which was designed to assess Zoraxel's safety and preliminary efficacy in male subjects ages 18 to 65 with ED, demonstrated a dose dependent treatment effect achieved by Zoraxel as assessed by the IIEF survey. Zoraxel was found to be safe and well tolerated, with no serious adverse events reported. Furthermore, subjects treated with Zoraxel demonstrated improved erectile function and significant improvement in the quality of life measures. Planning is underway for the Phase IIb trial, which will include the Sexual Encounter Profile (SEP) survey, IIEF and quality of life study endpoints."

It's been almost a year since Rexahn dropped that announcement, so what's taking so long for the company to provide the actual data from the study? Like with Serdaxin, Rexahn seems to prefer press releases over scientific publication or presentation at medical meetings.

A look at the Zoraxel study on ClinicalTrials.gov shows the phase II study enrolled 40 patients, randomized to one of three doses of Zoraxel (5 mg, 10 mg and 15 mg) or a placebo. The primary endpoints are scores on the International Index of Erectile Function (IIEF) and the Sexual Encounter Profile (SEP) -- both standard measures used in studies to assess erectile dysfunction.


Mark T. writes, "Thank you for all your wonderful insight into Cell Therapeutics (CTIC - Get Report). I was able to make some money on this stock because of your input. On another note, I am invested now in Celldex Therapeutics (CLDX - Get Report). Have you ever written about them? Can you provide us with some of your insight here? Is it the next Dendreon (DNDN)?"

Celldex's lead drug, CDX-110, is a cancer immunotherapy (so, a cancer "vaccine" cousin to Dendreon's Provenge) targeting glioblastoma multiforme (GBM) aka brain tumors as its lead indication. The data, to date, has been very promising albeit from small, uncontrolled studies, with median overall survival going out to 23-24 months.

CDX-110 is partnered with Pfizer (PFE), which refers to the drug as PF-04948568.

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