• Access Pharmaceuticals Inc., of Dallas, began its first Phase II study of ProLindac, a DACH platinum polymer prodrug in ovarian cancer patients who have relapsed after first-line platinum therapy. The trial is expected to accrue about 40 patients. Access anticipates initiating one or more additional studies within the next 12 months. Potential indications include colorectal and lung cancers in combination with existing treatment regimens.

• Array BioPharma Inc., of Boulder, Colo., and AstraZeneca plc, of London, initiated a Phase II study of AZD6244 in malignant melanoma. The first patient is expected to be enrolled before the end of June, triggering a $3 million milestone payment to Array, according to the December 2003 collaboration agreement. The 180-patient trial is designed to compare AZD6244, an MEK inhibitor, to temozolomide in Stage III/Stage IV melanoma. Additional Phase II studies in a range of other tumor types are expected to start over the next two to three months. (See BioWorld Today, Dec. 19, 2003.)

• Cortex Pharmaceuticals Inc., of Irvine, Calif., said it provided a preclinical research plan to the FDA for removing the clinical hold on Ampakine CX717, and the FDA responded that the proposed plan was acceptable. The agency placed a hold on Ampakine studies in April due to toxicology concerns. Cortex plans to submit all data, including results from a previously completed toxicology study, to the FDA in September. (See BioWorld Today, April 4, 2006.)

• GlobeImmune Inc., of Louisville, Colo., initiated a Phase II trial of GI-4000, its therapeutic vaccine for patients with early stage pancreatic cancer. The study is designed to compare the recurrence-free survival at 15 months in patients treated with either GI-4000 or placebo, in combination with adjuvant gemcitabine after surgery. GI-4000 is a Tarmogen (Targeted Molecular Immunogen), a yeast-based vaccine system aimed at stimulating killer T cells in the immune system to attack diseased cells.

• GPC Biotech AG, of Martinsried, Germany, said an independent Data Monitoring Board for the satraplatin Phase III registration trial Sparc in second-line chemotherapy for hormone-refractory prostate cancer held a meeting to review an interim analysis of overall survival data from the study. The DMB recommended the trial continue as planned, and no safety concerns were raised. GPC expects the full progression-free survival data to be available in the fall.

• Hollis-Eden Pharmaceuticals Inc., of San Diego, received FDA clearance to proceed with a Phase I/II dose-ranging human clinical trial with Neumune (HE2100) in patients at high-risk of developing health care-associated infections. The company's goal will be to establish the safety of Neumune and to help identify the optimal patient subsets for further study in Phase II efficacy trials.

• Morphotek Inc., of Exton, Pa., initiated Phase II studies of MORAb-003, a monoclonal antibody designed to target the folate receptor alpha, in ovarian cancer. The trials will evaluate the efficacy of MORAb-003, both as a single agent and in combination therapy with carboplatin and taxane, in ovarian cancer patients who experience their first relapse after primary surgery and chemotherapy, and still are sensitive to platinum chemotherapy.

• NeoPharm Inc., of Waukegan, Ill, received notification that its cintredekin besudotox (IL13-PE38QQR) pivotal Phase III Precise trial to treat glioblastoma multiforme has reached the criterion for the interim efficacy statistical analysis (160 deaths). The trial's independent data monitoring committee will assess the study to date and make a recommendation, indicating if the company has reached the pre-specified statistical endpoint or needs to continue to the final efficacy analysis at the 215th death, expected to occur in late 2006 or early 2007.

• Phenomix Corp., of San Diego, initiated a Phase II trial of PHX11149, an orally administered inhibitor of DPP-IV, in about 150 Type II diabetes patients. The trial's primary endpoint will involve the measurement of post-meal glucose levels. Secondary endpoints will measure post-meal insulin levels, fasting blood glucose and levels of a number of regulatory peptides, including GLP-1.

• Repligen Corp., of Waltham, Mass., started a clinical trial of RG1068, synthetic human secretin, as an agent to improve the detection of structural abnormalities of the pancreatic ducts during MRI imaging of the pancreas. The study will enroll 80 patients with a history of pancreatitis who will receive a secretin-enhanced MRI and an unenhanced MRI of the pancreas.

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