Drug Pipeline Series: Phase II, Dec 4 - Dec 11, 2006

Helix BioPharma Corp. announced that it has initiated patient enrollment in a Phase II clinical trial of Topical Interferon Alpha-2b for the treatment of ano-genital warts (condylomata accuminata) associated with human papilloma virus ("HPV") infection. The trial, which is taking place in Sweden, will assess the efficacy and safety of Topical Interferon Alpha-2b compared with placebo using a double blind, randomized design over an examination period of four months per patient.

Immtech Pharmaceuticals, Inc. announced that it has initiated a Phase II trial in the U.S. of its oral drug candidate, pafuramidine maleate, as a prophylaxis to prevent malaria infections for travelers to endemic regions. This study protocol was reviewed by the U.S. Food & Drug Administration and has been approved by the Institutional Review Board of a major U.S. medial center. It is estimated that each year 125 million travelers go to countries where malaria is endemic.

MethylGene Inc. , along with its partner Pharmion Corporation announced the initiation of a Phase II clinical trial with its isotype-specific histone deacetylase (HDAC) inhibitor product candidate, MGCD0103, in patients with high-risk myelodysplastic syndromes (MDS) or relapsed or refractory acute myelogenous leukemia (AML). Specific patient populations include elderly patients who have previously untreated disease or adult patients who have relapsed or refractory disease.

Cleveland BioLabs has begun a Phase II efficacy study of Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer.
Curaxin CBLC102 is an oral drug used in the past to treat malaria that demonstrates efficacy in vitro, in animal models and in live tumors removed from patients. Initial test results indicate that CBLC102 can be effective against a number of malignancies, including hormone refractory prostate cancer, renal-cell carcinoma and soft-tissue sarcoma.

Solvay Pharmaceuticals, Inc., Wyeth Pharmaceuticals, a division of Wyeth and Lundbeck A/S presented clinical study results for bifeprunox at a major medical conference this week. Bifeprunox is an investigational treatment for schizophrenia studied as a once-daily regimen. Results of these efficacy and safety studies showed that, in a six-month trial, bifeprunox maintained stability in patients with stable schizophrenia versus placebo.

EPIX Pharmaceuticals, Inc. announced the initiation of a Phase 2a clinical trial to further evaluate PRX-03140 as monotherapy and in combination with donepezil for the treatment of Alzheimer's disease. This Phase 2a trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once-daily for 14 days in patients with mild Alzheimer's disease who are on a stable dose of donepezil (10 mg). Data from this trial are expected in the second half of 2007.

Inspire Pharmaceuticals, Inc. announced the initiation of a Phase 2 clinical trial to evaluate epinastine nasal spray for the treatment of seasonal allergic rhinitis.
This Phase 2 clinical trial is a 14-day randomized, double-blind comparison of two doses of epinastine nasal spray (0.05% and 0.1%) to placebo in approximately 580 subjects who have a documented history of seasonal allergic rhinitis to mountain cedar pollen.