• Ariad Pharmaceuticals Inc., of Cambridge, Mass., started enrollment of 60 advanced cancer patients in a Phase Ib trial of its novel mTOR inhibitor, AP23573, in combination with doxorubicin. Doxorubicin is used in soft tissue and bone sarcomas, as well as breast, ovarian and endometrial cancers, all potential targets for AP23573 treatment. Preliminary Phase II results have demonstrated clinical responses and six-month progression-free survival in patients with advanced sarcomas who received the compound as a single agent. Ariad is on track to start a Phase III trial of single-agent AP23573 in advanced sarcomas later this year.

• Avant Immunotherapeutics Inc., of Needham, Mass., started a placebo-controlled, double-blind Phase I/II study of its typhoid fever vaccine candidate, Ty800. The trial, sponsored by the National Institute of Allergy and Infectious Disease, is being conducted at the Cincinnati Children’s Hospital Medical Center. It will evaluate three escalating doses of the vaccine in about 54 healthy adult volunteers and will follow each subject for six months.

• Axonyx Inc., of New York, reported a significant reduction in plasma levels of beta-amyloid 1-42 in healthy human subjects treated with Phenserine for 35 days. The additional analysis was completed as part of the program to identify a development partner for Phenserine. Six healthy men and six healthy women were enrolled in the multidose Phase I study. Subjects were treated with Phenserine 10 mg twice daily for 28 days and Phenserine 15 mg twice daily for an additional week.

• BioVex Inc., of Cambridge, Mass., said the first patients in its Phase II trials of OncoVEXGMCSF in malignant melanoma and in head and neck cancer had received their initial doses of the treatment. The melanoma trial is a 50-patient multicenter study, and the primary endpoint is tumor response rate with secondary endpoints including time to disease progression and median survival time. The head and neck cancer trial is a 16-patient open-label study in combination with chemoradiotherapy, and its endpoint is to assess safety and the potential of OncoVEX as neoadjuvant therapy. Preliminary results will be available later this year.

• Bone Medical Ltd., of Bentley, Australia, completed its Phase I study for oral parathyroid hormone (PTH), showing it achieved the primary endpoint of safety and produced evidence of biological activity. The company is moving into the next study to select the optimal formulation for the Phase II program. A short-term elevation in plasma calcium levels was seen in both the positive control (Forteo) and one of the oral PTH formulations, both of which were statistically significantly different from placebo.

• Ligand Pharmaceuticals Inc., of San Diego, earned a $2 million milestone payment from GlaxoSmithKline plc, of London, with that company’s beginning of Phase III trials of eltrombopag in adult patients with previously treated idiopathic thrombocytopenic purpura. Eltrombopag is an oral platelet growth factor that stimulates the proliferation and differentiation of megakayocytes.

• Metabasis Therapeutics Inc., of San Diego, initiated a Phase I trial of MB07803, a treatment for Type II diabetes. It is the second of a new class of drugs discovered by Metabasis that regulates glucose production in the liver by inhibiting an enzyme known as fructose 1,6 bisphosphatase. Metabasis retains all development and marketing rights to MB07803.

• Nektar Therapeutics Inc., of San Carlos, Calif., said the FDA granted orphan drug designation to the first amphotericin B inhalation powder for prevention of pulmonary fungal infections in patients at risk for aspergillosis due to immunosuppressive therapy. Using an inhaler, the company has conducted two Phase I trials and has long-term toxicity studies under way to support the planned pivotal trials early next year.

• Point Therapeutics Inc., of Boston, entered a collaboration with the National Cancer Institute in Bethesda, Md., to evaluate Point’s oral antitumor drug candidate, talabostat, in combination with chemotherapy in pediatric patients with solid tumors. Talabostat is designed to inhibit the dipeptidyl peptidase family of serine proteases, the company said.

• Santen Pharmaceutical Co. Ltd., of Osaka, Japan, reported preliminary results of the overseas trials of two drug candidates, an angiotensin II receptor antagonist (DE-092) and a prostaglandin derivative (DE-085), for lowering intraocular pressure (IOP) in glaucoma and ocular hypertension. Although data analysis indicated some IOP reduction for DE-092, the efficacy was insufficient, and no clear dose-response relationship was seen. Santen is considering development options such as conducting another dose-response study. For DE-085, early data demonstrate strong IOP-lowering effect, but the drug did not show non-inferiority to latanoprost for the primary endpoint. That study is ongoing.

No Comments