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Biotech Stock Mailbag: Xoma

Apparently, Cel-Sci forgot that you have to actually run a successful clinical trial and receive FDA approval before you can claim a drug to be safe and effective.

Details. Details.

Here's how Cel-Sci used to misleadingly promote Multikine, before the FDA slap:

"Phase II clinical trials of Multikine demonstrated the product was safe and well-tolerated and eliminated tumors in 12% of the subjects less than a month into treatment. The Multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. Follow-up studies of subjects enrolled in the "proof of concept" Phase II trial showed a 33% improvement in the survival rate of those treated with Multikine at a median of three and a half years following surgery."

And here's how Cel-Sci is characterizing Multikine today:

"In Phase II clinical studies, subjects with locally advanced disease who received the investigational therapy Multikine (Leukocyte Interleukin, Injection) as first-line investigational treatment were observed to have demonstrated a 33% increase in overall survival rate as compared to the overall survival rate that was determined from a review of 55 trials of the same cancer population, which were reported (in the scientific literature) between 1987 and 2007. However, no definitive conclusions can be drawn from these data about the potential efficacy profile of this investigational therapy. Moreover, further research is required, and these results must be confirmed in a well-controlled Phase III clinical trial of this investigational therapy that is currently in progress."

@JamesTrade22 tweets, "@adamfeuerstein what do you think about IGXT? They have an FDA date Nov. 13."

IntelGenx Technologies (IGXT) has an FDA approval decision date of Nov. 13 for CPI-300, a "novel" high-dose formulation of bupropion, the active ingredient in a Valeant Pharmaceuticals' (VRX) antidepressant Wellbutrin XL.

Apparently, IntelGenx has a drug delivery technology that can pack 450 mg of buproprion into a single pill. Right now, Wellbutrin and generic versions of bupropion are only commercially available in single-pill dosage strengths up to 300 mg. That means patients who require a 450 mg dose of bupropion take two pills (i.e. a 100 mg tablet and a 350 mg tablet) every day.

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