• Adolor Corp., of Exton, Pa., has begun a Phase II study of ADL5859, a novel delta opioid agonist in development for treatment of pain. Study 33CL230 targets dental pain and is the first of several planned proof-of-concept studies to explore the analgesic efficacy across a range of acute, inflammatory and neuropathic pain indications. Completion of study 33CL230 is targeted for early 2008. It is a randomized, double-blind, single-dose, active and placebo (ibuprofen) controlled parallel group study of approximately 200 subjects. The primary endpoint is pain relief. Adolor anticipates beginning additional proof-of-concept studies evaluating ADL5859 in other pain indications in the fourth quarter of 2007.

• BioCryst Pharmaceuticals Inc., of Birmingham, Ala., has reached agreement with the FDA for a special protocol assessment process for its pivotal trial of the oral formulation of Fodosine (forodesine hydrochloride) in patients with cutaneous T-cell lymphoma. The multicenter, multinational, open-label, single-arm, repeat-dose trial is expected to begin during the third quarter. The trial will enroll patients with CTCL of Stage IB through Stage IVA who have disease that is persistent, progressive or recurrent during or after treatment with at least three systemic therapies. The primary endpoint is the objective response rate, defined as either complete response or partial cutaneous response, achieved with a once-daily oral regimen of Fodosine. Secondary endpoints include safety and tolerability.

• Cougar Biotechnology Inc., of Los Angeles, presented positive Phase I and Phase II data on its prostate cancer drug candidate CB7630 (abiraterone acetate). In the 38 patients who were evaluable in the Phase I/II trial, 33 patients (87 percent) experienced a decline in prostate specific antigen (PSA) levels with 23 patients (61 percent) experiencing a confirmed decline in PSA levels of greater than 50 percent, and with 10 of the 38 patients (26 percent) experiencing PSA declines of greater than 90 percent. Of the 20 evaluable patients with measurable tumor lesions, treatment with CB7630 resulted in partial radiological responses (as measured by the RECIST criteria) in 11 patients (55 percent), with seven patients demonstrating ongoing stable disease and three experienced regressing bone disease. Individual patients treated with CB7630 also experienced improvement in pain and a reduction in opioid use. The data were presented at the European Society for Medical Oncology Conference in Lugano, Switzerland.

• Geron Corp., of Menlo Park, Calif., began a Phase I/II trial of the telomerase inhibitor GRN163L in patients with advanced non-small-cell lung cancer. The primary objective of the study is to determine the safety and maximum tolerated dose of GRN163L when administered intravenously in combination with a standard paclitaxel/carboplatin regimen. This is the first time GRN163L is being clinically tested in combination with standard chemotherapy.

• Kamada Ltd., of Ness Ziona, Israel, said that following discussions with the European Agency for the Evaluation of Medicinal Products, it is planning a Phase II trial of its inhaled alpha-1 antitrypsin product to treat cystic fibrosis. An ongoing Phase I trial is showing good intermediate results, the company said. Kamada also recently received EMEA approval for its plans for Phase II/III trials of AAT for treating congenital emphysema.

• Kiadis Pharma BV, of Groningen, the Netherlands, said the U.S. National Institutes of Health will begin a Phase II trial with Kiadis' ATIR product. Following existing trials in Canada and Europe that focus on mismatched bone marrow transplants, this will be the first trial with ATIR as treatment for conventional HLA matched transplants. ATIR will be investigated as a treatment option for terminally ill blood cancer patients. The study will evaluate the safety and efficacy of ATIR as a selective depletion procedure in HLA-matched transplants.

• MacroGenics Inc., of Rockville, Md., said its investigational new drug application to the FDA for its monoclonal antibody targeted to West Nile virus is now active. MGAWN1 is a humanized monoclonal antibody designed to specifically neutralize the virus. A Phase I trial in healthy volunteers is expected to begin this year. In September 2006, MacroGenics was awarded a $50 million contract from the National Institute for Allergy and Infectious Diseases to support the development of MGAWN1 through manufacturing and Phase II trials. (See BioWorld Today, Oct. 4, 2006.)

• MediGene AG, of Martinsried, Germany, said the modified herpes simplex virus NV1020 is showing early promise in a Phase I/II study in patients with metastatic colorectal cancer. NV1020 is designed to selectively replicate in virus cells, killing them in the process. Early safety and efficacy results, as well as a positive case report, were presented at the Society for Medical Oncology Conference in Lugano, Switzerland.

• NexMed Inc., of East Windsor, N.J., said Novartis Pharma AG, of Basel, Switzerland, completed patient enrollment in Phase III trials of NM100060, a topical treatment for onychomycosis (nail fungus). NM100060 is a topical application of Lamisil (terbinafine), formulated with terbinafine and NexMed's NexACT permeation enhancer technology. Novartis licensed rights to the product in September 2005. (See BioWorld Today, Sept. 16, 2005.)

• OxiGene Inc., of Waltham, Mass., began a pivotal registration study of its vascular disrupting agent Zybrestat (combretastatin-A4 phosphate/CA4P) in patients with metastatic anaplastic thyroid cancer. The randomized, controlled, Phase II/III study is being conducted under a special protocol assessment agreement reached with the FDA in May. The trial is expected to enroll about 180 patients at about 45 sites in the U.S., Eastern and Western Europe, Asia, and the Middle East. Two-thirds of the patients will be administered intravenous Zybrestat plus carboplatin and paclitaxel, and the other third will receive carboplatin and paclitaxel alone. The primary endpoint is overall survival rates. The study design incorporates a planned interim analysis for efficacy and safety.

• Pro-Pharmaceuticals Inc., of Newton, Mass., provided data from eight patients in a Phase II trial of Davanat with chemotherapy in first-line metastatic colorectal cancer. Two patients had tumor shrinkage of greater than 30 percent. Five patients had stable disease for up to seven months. Phase II data on seven patients with biliary cancer treated with the delivery compound and 5-FU showed one patient had tumor shrinkage of greater than 30 percent. Five patients had stable disease for up to five months. The company has submitted data to begin 505 (b)(2) filings with the FDA for Davanat to be used as a functional excipient, with 5-FU and with irinotecan.

• Response Genetics Inc., of Los Angeles, said Phase III data published in the Journal of Clinical Oncology suggested that low expression of the biomarker Excision-Repair Cross-Complementing 1 (ERCC-1) in patient biopsies with advanced non-small-cell lung cancer predicts for sensitivity to cisplatin-based chemotherapy. ERCC-1 is an enzyme involved in repair of DNA strand breaks such as those caused by cisplatin. The analysis of ERCC-1 levels in the study was conducted by Response Genetics using its RGI-1 technology. It said it was the first prospective study using a biomarker to predict chemotherapy response in lung cancer.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said it filed an investigational new drug application with the FDA for a Phase I trial of SPI-1620 in patients with recurrent or progressive carcinoma. SPI-1620 is being developed as an adjunct to chemotherapy. It is a highly selective endothelin-B agonist that has demonstrated in experimental models a transient and selective increase in blood flow to tumors and a consequent increase in delivery of anticancer drugs to the tumor while essentially sparing normal tissues and organs, Spectrum said.

• ViaCell Inc., of Cambridge, Mass., got FDA approval of its investigational device exemption supplement for its ViaCyte pivotal trial to evaluate product in cryopreservation and thawing of human oocytes for use during assisted reproductive technology. FDA approval of the IDE supplement allows the company to enroll women into the study and commence in vitro fertilization treatment. Previously, the FDA disapproved the IDE supplement, asking ViaCell to respond to questions related to the specifications and sourcing of certain raw materials used in the manufacturing of the ViaCyte media. All questions have been addressed and no conditions are outstanding.

• YM BioSciences Inc., of Mississaugo, Ontario, said a study presented by investigators from Kinki University School of Medicine and Kyoto University at the meeting of The Japanese Association for Molecular Target Therapy of Cancer showed increased radiosensitivity of human non-small-cell lung cancer cell lines in the presence of nimotuzumab both in vitro and in vivo. The study also confirms previous observations that nimotuzumab inhibits ligand-dependent EGF receptor downstream signaling. Daiichi Sankyo Co. Ltd., of Tokyo, is the licensee for nimotuzumab in Japan. Also, YM said a paper was presented at the SBNet meeting in Tallberg, Sweden, dealt with the structure of EGFr signaling.

• Ziopharm Oncology Inc., of New York, presented two posters at the International Myeloma Workshop in Kos, Greece. One poster highlighted preclinical data demonstrating darinaparsin (ZIO-101) may have activity in myeloma patients who already have been treated with and no longer respond to arsenic trioxide. The second reiterated positive interim Phase II data from two ongoing studies recently presented at the American Society of Clinical Oncology meeting.