ImClone previously licensed CDP-791 to UCB. ImClone will, however, receive royalties on CDP-791, if it is commercialized. CDP-791 is currently undergoing a Phase IIa trial in patients with non-small cell lung cancer, with results expected in few months. The ImClone drug, IMC-1121B, will complete a number of Phase I trials in the first half of 2007. In the first reported results, IMC-1121B produced 2 partial responses and 7 instances of stable disease (lasting more than six months) in 23 patients, all of whom had advanced cancer. ImClone slid 21 cents lower to $29.27.
Synta (SNTA) priced its IPO at $10 per share, a one-third reduction from the midpoint of its proposed $14-$16 range. Synta placed 5 million shares (a 1 million share drop from its earlier announcements), and it has 32 million shares outstanding after the offering, giving the company a market cap of $290 million. Synta’s lead drug is an injectible solid tumor cancer drug that has been given Fast-Track designation. It will begin Phase III trials in mid-2007. Synta had a rough time of it in the after-market, falling 91 cents or 9% to end at $9.09.
CytRx (CYTR) will determine the maximum safe dosage of arimoclomal, an oral drug for amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), and then the company will use the dosage in a Phase IIb double-blind trial. CytRx hopes that the Phase IIb data will be sufficient to use as the basis for FDA approval. The Phase IIb trial is scheduled to begin in Q3 of 2007. CytRx edged 3 cents higher to $2.90.
Genta (OTC:GNTA) will appeal the non-approvable ruling given by the FDA for Genasense in chronic leukemia patients. Genta contends that Genasense met its primary endpoint by increasing the percentage of complete responses from 7% to 17%. Genta has few other options left; the stock closed at $.48.
Avigen (AVGN) reported that AV411 (ibudilast) was well tolerated in Phase I trial. Ibudilast has been in use in Japan for 15 years as an asthma treatment. Avigen is seeking to up the dosage and use the drug as a treatment for neuropathic pain. In Australia, AV411 is in the middle of a Phase IIa trial, which should be completed before the end of the year. Avigen rose 7 cents to $6.11.
BioCryst (BCRX) said oncology drug Fodosine was given Orphan Drug status in Europe for cutaneous T-cell lymphoma [CTCL]. Previously, the drug won Orphan status for T-cell acute lymphoblastic leukemia [ALL]. BioCryst out-licensed the European rights for Fodosine to Mundipharma. Fodosine has Orphan Drug status in the US for three indications. BioCryst dropped 20 cents to $10.54.
ViaCell (VIAC) reported disappointing results from a Phase I trial of its umbilical cord blood transplant therapy, CB001. CB001 used ViaCell’s proprietary technology to expand stem cells from a single umbilical cord, but the results were no better than those obtained by using blood from two cords, without the expansion technology. ViaCell said it would not develop the technology further. ViaCell lost 5 cents to end at $5.28.
GenVec (GNVC) published data from pre-clinical tests showing that its adenovector technology delivered the math1 gene to inner ear cells of mice, re-generating inner ear hair cells and restoring a sense of balance. GenVec moved 18 cents higher to $3.39.
Biotech staged a late-session rally that wiped out most, though not all, of the early session losses. At the end of the day, most indexes were close to their starting points. The Centient Biotech 200™ was 4 points lower at 4050, a decline of .10%. The S&P 500 was up by .07% and Nasdaq gained .04%.