• Amgen Inc., of Thousand Oaks, Calif., said the FDA has accepted the biologic license application for panitumumab, a fully human monoclonal antibody that targets the epidermal growth factor receptor, and has granted priority review. The rolling BLA submission was initiated in December and completed in March and aims to gain approval of panitumumab to treat metastatic colorectal cancer patients who have failed prior chemotherapy. The drug received fast-track designation from the FDA in July 2005.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, launched a Phase II/III study of Ceflatonin (homoharringtonine, HHT) in patients with chronic, accelerated and blast-phase chronic myeloid leukemia who have T3151 BCR-ABL point mutation, which is associated with Gleevec resistance. The study is projected to enroll up to 81 patients within 12 months. The primary endpoint will be hematologic response rate, and cytogenetic response rate will be the secondary endpoint.

• Forbes Medi-Tech Inc., of Vancouver, British Columbia, completed enrollment for the U.S. Phase II trial of its cholesterol-lowering compound, FM-VP4. There have not been any significant safety issues or concerns raised to date. The primary efficacy objective is to determine the effect of two doses of FM-VP4, 450 mg and 900 mg, given for 12 weeks, compared to placebo, on low density lipoprotein-cholesterol. The goal is to demonstrate a minimum of 15 percent reduction from baseline in LDL-C at week 12. The trial should be completed by the end of the third quarter.

• Genitope Corp., of Redwood City, Calif., said MyVax personalized immunotherapy received fast-track designation from the FDA for the treatment of follicular non-Hodgkin's lymphoma. The company has initiated a Phase III pivotal trial of MyVax in Stage III/IV fNHL patients. Results from a Phase II trial showed that nine of the 21 patients enrolled remained progression-free as of their last clinical follow-up at 56 to 78 months post-chemotherapy.

• IDM Pharma Inc., of Irvine, Calif., received a special protocol assessment from the FDA for a Phase II/III trial of Bexidem in superficial bladder cancer. The trial is expected to enroll about 300 patients with a history of failure with BCG treatment, and measure time to recurrence as the primary endpoint. Bexidem is composed of monocyte-derived activated killer (MAK) cells produced from the patient's own white blood cells and activated ex vivo to allow them to recognize and destroy tumor cells.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., reported positive Phase II results of ISIS 113715 in Type II diabetes, showing that patients who received 200 mg/wk for three months demonstrated statistically significant improvement in multiple measures of glucose control, and the drug did not cause hypoglycemia or weight gain. ISIS 113715, a second-generation antisense drug, is designed as an insulin sensitizer to reduce the expression of protein tyrosine phosphatase-1B, a mediator of insulin resistance.

• MediciNova Inc., of San Diego, initiated a clinical development program to evaluate MN-221, a selective B2-adrenergic receptor agonist, in status asthmaticus. The company plans to begin a Phase II study under a U.S. investigational new drug application later this year.

• NeurogesX Inc., of San Carlos, Calif., completed enrollment in its 400-patient Phase III trial of Transacin (NGX-4010), a high-concentration trans-capsaicin dermal patch, in postherpetic neuralgia. Results of the study are expected in the fourth quarter, and if positive, will be part of a marketing application for Transacin in Europe early next year. A confirmatory Phase III PHN study is being initiated in North America. (See BioWorld Today, June 16, 2005.)

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., said Nexavar (sorafenib) tablets were granted fast-track designation by the FDA for metastatic hepatocellular carcinoma. It will allow the company to file a new drug application on a rolling basis as data become available. A Phase III advanced liver cancer trial recently completed patient enrollment. The drug was approved by the FDA in December for the treatment of patients with advanced renal-cell carcinoma.

• OSI Pharmaceuticals Inc., of Melville, N.Y., reported positive results from its Phase IIa proof-of-concept study of its dipeptidyl peptidase-IV (DP-IV) inhibitor, PSN9301, indicating that 14-day administration of the drug reduced blood glucose levels in patients with Type II diabetes. The drug also appeared well tolerated with no episodes of hypoglycemia. Results were presented at the American Diabetes Association meeting in Washington.

• Predix Pharmaceuticals Holdings Inc., of Lexington, Mass., reported Phase II data of its lead candidate, PRX-00023, that showed significantly reduced symptoms in 21 patients with generalized anxiety disorder. Six of the 19 patients (32 percent) achieved remission criteria based on the Hamilton Anxiety Rating Scale (HAM-A) after four weeks of treatment, and 52 percent of patients had a 50 percent or greater reduction in the HAM-A total scale. Results were presented at the New Clinical Drug Evaluation Unit meeting in Boca Raton, Fla.

• Speedel Group, of Basel, Switzerland, reported Phase III data of SPP100 (Rasilez) in diabetic patients with hypertension, demonstrating the drug's efficacy and safety as both a monotherapy and in combination with ramipril, an ACE inhibitor. Results showed that co-administration therapy provided an additional BP reduction of 4.6/2.1 mmHg over that achieved with standard ACE-I treatment. In addition, data suggested that combination therapy reduces the incidence of cough associated with ramipril. SPP100 is under review at the FDA. Data were presented by Speedel's partner, Basel, Switzerland-based Novartis AG, during the European Society of Hypertension meeting in Madrid, Spain.

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