• Lexicon Genetics Inc., of The Woodlands, Texas, completed the third performance milestone in its alliance with South San Francisco-based Genentech Inc. Lexicon identified the physiological and behavioral functions of 50 percent of the proteins included in the alliance, triggering a substantial payment from Genentech. Under the alliance, Lexicon is discovering the functions of potential therapeutic proteins and antibody targets identified through Genentech's internal research. The companies entered their agreement in 2002. (See BioWorld Today, Dec. 19, 2002.)

• Ligand Pharmaceuticals Inc., of San Diego, and TAP Pharmaceutical Products Inc., of Lake Forest, Ill., agreed to extend their research collaboration focused on the discovery and development of selective androgen receptor modulators (SARMs). The collaboration, which began in 2001, already has SARM molecules in advanced preclinical development to treat major androgen-related conditions. One product, LGD2941, could be the subject of an investigational new drug application filing in the first half of 2005. SARMs might address conditions such as hypogonadism, osteoporosis, sexual dysfunction and frailty. TAP holds exclusive worldwide rights to manufacture, develop and sell any products, and Ligand is entitled to receive $3.4 million in 2005 in collaborative revenue, as well as double-digit royalties and up to $44 million in research funding and milestones if two products are developed. Ligand retains rights to the prevention or treatment of benign prostate cancer, benign prostatic hyperplasia, acne and hirsutism. (See BioWorld Today, June 27, 2001.)

• Medivir AB, of Huddinge, Sweden, said it will continue development of the HIV compound MIV-210, though London-based GlaxoSmithKline plc terminated their research agreement. Medivir plans to initiate a Phase IIa study in HIV drug-experienced patients in 2005 to determine MIV-210's effectiveness. The cost of the trial is estimated at less than $1 million, it said.

• Telik Inc., of Palo Alto, Calif., completed enrollment for the ASSIST-1 trial of Telcyta (TLK286). The randomized, Phase III trial will involve 440 women in third-line treatment of platinum refractory or resistant ovarian cancer. The company also plans for two other Phase III ASSIST (Assessment of Survival in Solid Tumors) trials to test Telcyta, a small-molecule drug candidate designed to be activated by GST P1-1, an enzyme present in cancer cells, to cause apoptosis. Enrollment for the 520-patient ASSIST-2 trial is expected to be completed in the first quarter and will evaluate Telcyta as treatment for platinum resistant non-small-cell lung cancer. Telik just initiated the ASSIST-3 trial, designed to enroll 244 women and to test Telcyta as a treatment in second-line platinum refractory ovarian cancer.

• The Medicines Co., of Parsippany, N.J., completed the Evolution-On Phase III trial of Angiomax (bivalirudin), the second of two safety trials that evaluated the use of Angiomax as an anticoagulant during cardiac surgeries conducted with a pulmonary bypass machine. The company reported that patients treated with Angiomax demonstrated a 95 percent success rate, compared to a 91.8 percent success rate in patients treated with heparin and protamine reversal. Acute procedural success was defined at seven days post-surgery as absence of death, Q-wave MI (heart attack), repeat operation or catheterization for coronary revascularization or stroke. The efficacy Phase III program will evaluate the effect of Angiomax on patients with or at risk for HIT/TS who will undergo on-pump and off-pump cardiac surgery. If successful, The Medicines Co. said it will then file for U.S. regulatory clearance.

• Washington University School of Medicine in St. Louis said a recently developed mouse model of brain tumors common in the genetic disorder neurofibromatosis 1 (NF1) mimics the human condition, which might provide insight into diagnosis and treatment. NF1 is a neurological disorder caused by a single gene mutation and can lead to brain cancer. The study appears online and will be published in the January 2005 issue of Annals of Neurology.

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