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Alfacell (OTC:ACEL) received Orphan Drug designation for Onconase, a treatment for malignant mesothelioma that is in a confirmatory Phase IIIb trial. Interim results from the trial show a 20% increase in overall survival. The drug is also in Phase I/II trials for non-small cell lung cancer and solid tumors.

Critical Therapeutics
(NASDAQ:CRTX) has out-licensed its vagus nerve stimulation IP to Innovative Metabolics. The vagus nerve is thought to be significant in regulating an inflammatory response. Critical Therapeutics will receive $500,000 in cash plus an unspecified number of preferred shares. If Innovative Metabolics receives all regulatory approvals, Critical Therapeutics will receive a $1 million milestone, plus royalties. Innovative Metabolics is owned by the two founders of Critical Therapeutics.

BioSante Pharma (BPA) reported positive pre-clinical results for a flu vaccine adjuvant, BioVant. The calcium phosphate nanoparticle-based adjuvant was effective in mice in a dose ranging study, producing higher concentrations of H5N1 antibodies than produced by the antigen alone.

Compugen (NASDAQ:CGEN) will collaborate with Teva Pharma (NYSE:TEVA) to discover biomarkers that detect drug toxicity in preclinical drug development. The first target will be nephrotoxicity. Teva has the right to use the biomarkers in its clinical development work, while Compugen will retain the right to commercialize the discoveries.

In a separate announcement, Teva said it received approval of a generic version of Focalin, a Novartis (NYSE:NVS) drug that treats ADHD. Teva will have 180 days of marketing exclusivity.

Exelixis (NASDAQ:EXEL) submitted an Investigational New Drug application for XL418, a new anti-cancer drug. XL418 inhibits the protein kinase B [PKB or AKT] and S6 Kinase [S6K]. Both of these are components of the phosphoinosotide-3 kinase (PI3K) signaling pathway, which promotes cell growth and resistance to chemotherapy and radiotherapy.

Lexicon Genetics (OTCQB:LEXG) began a Phase Ib trial of LX6171, an oral drug that treats the cognitive impairment of Alzheimer’s, schizophrenia and vascular dementia. The trial is a placebo-controlled, ascending-dose study. The drug will be administered to healthy volunteers, many of them elderly. Results are expected in mid-2007. Lexicon also announced it would change its name to Lexicon Pharmaceuticals as it shifts focus from its genetics discovery operations towards advancing 10 products into the clinic by 2010.

ZymoGenetics (ZGEN) has put its hepatitis C drug candidate, PEG-Interferon lambda, into a Phase I trial. The goal will be to produce a drug for hepatitis C that has fewer side effects than the currently used PEG-Interferon alpha.

Merck Serono (SRA) launched easypod in the US. Easypod is an injection device for the once-daily administration of Saizen, a growth hormone. The device allows the doctor to set the dosage, and the device also confirms administration of the drug. The goal is to minimize pain. Easypod is already in use in Europe and Canada.

Threshold Pharma (NASDAQ:THLD) began a Phase II trial of glufosfamide in patients with platinum-resistant ovarian cancer. The platinum chemotherapies are the main therapies for ovarian cancer. If a patient is resistant to platinum drugs, which occurs in almost half the cases, there are few alternatives available.

Immtech Pharma (IMM) has completed enrollment in a Phase III trial of an oral drug, pafuramidine meleate, for African sleeping sickness. The current treatment is administered by injection, making a blinded test difficult. Interim data will be reported after half the patients return for their 12-month checkup, an event that should take place by mid-2007.

Biotech moved higher in today’s session, regaining some of the ground lost recently. The Centient Biotech 200™ rose 25 points to 4033, a gain of .60%. The S&P 500 moved up .58% and Nasdaq was higher by .31%.


Disclosure: none.

Source: Biotech Stocks Day In Review: Alfacell Receives Orphan Drug Status For Onconase