• Astex Therapeutics Ltd., of Cambridge, UK, said the FDA approved its investigational new drug application for the clinical development of AT9283, an aurora kinase inhibitor for cancer. An initial Phase I study in hematological cancers is expected to begin at U.S. oncology centers, and additional studies are expected to start during the second half of the year in patients with solid tumors. AT9283 was discovered and developed using Pyramid, Astex's fragment-based drug discovery platform.

• Cytos Biotechnology AG, of Zurich, Switzerland, reported positive follow-up results from its Phase IIa study of CYT005-AllQbG10 to treat allergic diseases. Data from the 20-patient trial in rhinoconjunctivitis and asthma due to house dust mite allergy demonstrated that the efficacy achieved with the drug provides a therapeutic benefit for an extended period of time. Follow-up results were obtained eight months after the start of treatment and 24 weeks after the last injection.

• Debiopharm SA, of Lausanne, Switzerland, said results of a Phase II study of once-daily oral administration of ZT-1 demonstrated efficacy in patients with mild to moderate Alzheimer's disease. The company also reported results from a Phase I study of a monthly sustained ZT-1 implant that showed no safety concerns and good tolerance. The data were presented at the 9th International Geneva Springfield Symposium on Advances in Alzheimer Therapy.

• EntreMed Inc., of Rockville, Md., began a Phase Ib study to test its lead drug candidate, Panzem NCD (2-methoxyestradiol; 2ME2), in combination with paclitaxel in patients with metastatic breast cancer. The single-center study will be conducted at the Duke University Medical Center under a grant from the Susan G. Komen Breast Cancer Foundation. The study will evaluate the safety and tolerability of Panzem NCD in combination with weekly paclitaxel, and it will evaluate the biologic effects on tissue and plasma in patients treated with paclitaxel alone and in combination with Panzem NCD.

• NeoPharm Inc., of San Francisco, said Phase I data showed that cintredekin besudotox (IL13-PE38QQR) is safe and well tolerated in newly diagnosed malignant glioma patients when used in combination with radiation therapy and temozolomide. Results were presented at the 74th annual meeting of the American Association of Neurological Surgeons held in San Francisco. Nineteen patients were enrolled, and all received cintredekin besudotox.

• NeoRx Corp., of Seattle, expanded the Phase II trial with picoplatin for lung cancer into selected Eastern European countries with the treatment of the first patients there. Picoplatin, which is a new-generation platinum therapy and the company's lead oncology candidate, continues to enroll patients with small-cell lung cancer at clinical sites in the U.S. and Canada.

• Ortec International Inc., of New York, completed patient enrollment of a trial designed to confirm the superiority of cryopreserved OrCel in the healing of difficult-to-heal venous leg ulcers in comparison to the standard of care therapy. Upon completion of the 12-week treatment for the last patient enrolled, the data of the trial will be analyzed. The company intends to integrate the primary endpoint efficacy data of the 61 patients enrolled with results of 61 patients from its pivotal trial, and the combined results will be analyzed and reported using a Bayesian statistical approach. The primary endpoint is 100 percent wound closure within 12 weeks.

• Osiris Therapeutics Inc., of Baltimore, completed enrollment of 55 patients in a Phase I/II trial designed to evaluate Chondrogen, a preparation of adult stem cells formulated for direct injection into the knee. Chondrogen is being studied to regenerate meniscus in those patients. Osiris has four other stem cell trials ongoing: two Phase II studies in graft-vs.-host disease, one Phase II in Crohn's disease and a Phase I trial for the repair of heart tissue following heart attack.

• Stem Cell Therapeutics Corp., of Calgary, Alberta, entered an agreement to support a Phase IIa safety study examining the effects of NTx-265 in stroke patients. The safety trial has been reviewed and approved by the FDA and the institutional review board of the University of California at Irvine. The study, expected to enroll about 12 subjects, will be conducted by Steven Cramer, a stroke specialist at UCI.

• Transgene SA, of Strasbourg, France, disclosed positive results of the Phase II trial with TG4001 in the treatment of high-grade cervical intraepithelial neoplasia (CIN2/3), which is related to human papillomavirus type 16 (HPV16). Results were presented during the Eurogin 2006 Congress held in Paris. The trial at nine centers in France enrolled 21 women with HPV16 CIN2/3, and six-month data are available for 18 patients. Of those, 10 had a normal colposcopy, nine showed no CIN2/3 and nine showed no HPV16 E6/E7 mRNA. Surgery was avoided in nine out of the 18 women.