• Access Pharmaceuticals Inc.,of Dallas, said it began enrolling patients in a Phase I/II ovarian cancer patient trial in multiple centers in Europe with a target of 50 patients. The product, AP5280, in preclinical trials formed in excess of 11 times more tumor platinum DNA adducts, which is the mechanism of action of platinum drugs.

• Albany Molecular Research Inc., of Albany, N.Y., entered a renewable one-year pharmaceutical research and development collaboration with Takeda Chemical Industries Ltd., of Osaka, Japan. AMRI will conduct chemistry research to identify and develop small-molecule drug candidates against a Takeda target. AMRI will receive fees based on the number of scientists working on Takeda projects. In addition, AMRI may receive success fees for meeting certain development milestones on new compounds for which an AMRI scientist is listed as an inventor. AMRI also may receive a royalty on net sales of commercial products that result from the collaboration. Other financial terms were not disclosed.

• Alkermes Inc., of Cambridge, Mass., commenced an offer to exchange up to $115 million aggregate principal amount of its new 6.52 percent convertible senior subordinated notes due Dec. 31, 2009, for up to an aggregate principal amount of $200 million of its currently outstanding 3.75 percent notes due 2007. The company also is offering holders of outstanding notes who participate in the exchange offer the right to purchase for cash up to an additional $50 million aggregate principal amount of its new notes. The exchange offer is scheduled to expire on Dec. 24, unless extended, Alkermes said.

• Biogen Inc., of Cambridge, Mass., said data published in the Nov. 26, 2002, issue of Neurology show its multiple sclerosis drug, Avonex, is as effective at 30 mcg once weekly as it is at 60 mcg. The study was conducted at 38 centers in Europe and involved more than 800 patients. The company said the trial "provides clear, high-quality evidence that the higher dosage . . . confers no therapeutic advantage."

• Bio-Technology General Corp., of East Brunswick, N.J., said the U.S. Court of Appeals for the Federal Circuit vacated an injunction. As a result, BTG's recombinant human growth hormone now can be marketed in the U.S. The product is designed to treat growth hormone deficiency in children and is marketed in more than 30 countries worldwide.

• Boston Life Sciences Inc., of Boston, entered an agreement with certain investors and Brown Simpson Partners I Ltd. under which the company consented to the transfer of outstanding warrants to purchase about 1.8 million shares of its common stock (warrants) previously owned by Brown Simpson. Effective upon the transfer, the terms of the warrants were amended, among other things, to reduce the exercise price from $2.15 per share to $2 per share, to extend the expiration date from Sept. 22, 2004, to Dec. 31, 2006, and to eliminate the reset provisions. Also, the antidilution provisions were modified to provide only for customary events such as stock splits. As a result of these transactions, the conversion price of the company's 10 percent convertible senior secured promissory note issued to Ingalls & Snyder Value Partners in July 2002 was reduced from $2.16 per share to $2 per share. Boston Life Sciences is developing diagnostics and therapeutics for Parkinson's disease and attention deficit hyperactivity disorder, among other things.

• CytoGenix Inc., of Houston, formed a collaboration with Madeleine Duvic, professor of internal medicine and dermatology, division of internal medicine and deputy chair of dermatology, at The University of Texas M.D. Anderson Cancer Center in Houston. The purpose is to investigate, test and evaluate a gene believed to be related to melanoma. Building on Duvic's team's research, CytoGenix scientists will be using the company's ssDNA Expression System to construct and deliver target-specific gene knockout sequences to melanoma cancer cells.

• Direvo Biotech AG, of Cologne, Germany, said it raised 10.5 million in its Series B equity financing round. Danisco Venture, of Copenhagen, Denmark, served as lead investor, with TVM, of Munich, Germany, as co-lead investor. Separately, Direvo said it entered a collaboration with Danisco A/S, of Copenhagen, to develop an industrial enzyme. Direvo focuses on screening-based directed evolution and applies its technologies to develop better biopharmaceuticals, industrial enzymes, chemical biocatalysts and enzymes for food and feed.

• Genta Inc., of Berkeley Heights, N.J., said new data that show broad genomic and preclinical anticancer activity of one of the company's pipeline products, the CRE-decoy aptamer, were presented at the Molecular Targets and Cancer Therapeutics conference in Frankfurt, Germany. A region of DNA, known as the cyclic AMP response element, regulates the function of a number of genes involved in cancer cell growth and division, the company said. Those genes are activated when a complex of proteins bind to that region of DNA. The drug binds to and blocks the protein complexes that would normally turn on genes regulated by CRE, thereby inhibiting cancer cell growth.

• GenVec Inc., of Gaithersburg, Md., began a Phase I trial of its ophthalmology product candidate, AdPEDF, in patients with age-related macular degeneration. A total of up to 51 patients with severe AMD may be enrolled in the multicenter dose-escalating study. The study primarily is assessing safety.

• Idexx Laboratories Inc., of Westbrook, Maine, said it was informed verbally by the FDA that the agency expects to provide further comments regarding Idexx's application for approval of nitazoxanide, including comments on the proposed labeling for the product and other matters not disclosed by the FDA. Written comments are expected in the next four to eight weeks. As a result, Idexx anticipates an additional delay in the introduction of nitazoxanide; it previously had anticipated FDA approval of the product in early 2003. Nitazoxanide is a product for the treatment of equine protozoal myeloencephalitis.

• Medisyn Technologies Inc., of Minneapolis, said it completed a $1.6 million financing. Sherpa Partners led the round, with StarTec Investments also participating. Proceeds from the round will be used to increase research into its lead drug candidates. Medisyn is focused on treating cancer.

• MerLion Pharmaceuticals Pte. Ltd., of Singapore, and Abbott Laboratories, of Abbott Park, Ill., are collaborating on the discovery of natural product-based drugs for use in a range of therapeutic areas, including oncology, metabolics, antivirals, immunology and neuroscience. Abbott will contribute a number of targets for MerLion to screen against its sample collection. Abbott will perform lead optimization, development and marketing of products. MerLion will receive research and milestone payments and royalties, plus it will have rights to selected discoveries not progressed by Abbott. Financial terms were not disclosed.

• MGI Pharma Inc., of Minneapolis, and Helsinn Healthcare SA, of Lugano, Switzerland, said the FDA accepted their new drug application for filing. The NDA was submitted in September for approval to market palonosetron, a product designed to prevent chemotherapy-induced nausea and vomiting. Palonosetron is a selective 5-HT3 receptor antagonist.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., said it submitted a biologics license application to the FDA for Nabi-HB Intravenous, Hepatitis B Immune Globulin (Human) to prevent liver transplant patients from suffering re-infection of their transplanted livers with hepatitis B virus. Nabi-HB is a sterile solution of human antibodies already approved by the FDA for preventing infection with hepatitis B virus upon acute exposure. The product is produced by Nabi at its plant in Boca Raton and has been granted orphan drug designation for its use in liver transplant patients.

• National Institute of General Medicine Sciences researchers in Bethesda, Md., have determined the structure of a protein with a surprising feature in it: a knot. The institute said it is the first time a knot has been found in a protein from the most ancient type of single-celled organism, an archaebacterium, and one of only a few times a knot has been seen in any protein structure. The protein shape finding results from the NIGMS Protein Structure Initiative, a 10-year effort to determine 10,000 unique protein structures using highly automated methods. The researchers describe the new protein structure in Proteins. The article was scheduled for online publication Nov. 27 and in print in early December.

• NeoPharm Inc., of Lake Forest, Ill., reported that additional Phase I/II trial data on IL13-PE38, its tumor-targeting agent for malignant glioma, were presented at the seventh annual meeting of the Society for Neuro-Oncology in San Diego. An abstract of the presentation appeared in the October 2002 issue of Neuro-Oncology. The results were from 14 patients from one of three ongoing IL13-PE38 Phase I/II trials. The preliminary data built on previous study findings indicating the cytotoxic effects of IL13-PE38 against malignant glioma tumor cells, when infused into the tumor site using convection-enhanced delivery. The study findings indicate that it was well tolerated, and evidence of tumor necrosis and prolonged patient survival was observed.

• Neuro Bioscience Inc., of Salt Lake City, was acquired by Mortgage Professional Lead Source Inc., of New York. Mortgage Professional Lead Source now has changed its name to Neuro Bioscience Inc. and trades on the OTC Bulletin Board under the symbol NUBI. Financial details were not disclosed. Neuro Bioscience has five platform technologies in development targeted against Alzheimer's disease, depression, multiple sclerosis, Parkinson's disease and arthritis.

• Novactyl Inc., of St. Louis, began enrolling patients in a Phase IIa trial of PCL-016 in mild to moderate acne. PCL-016, a member of a class of agents that target zinc-finger proteins involved in infective disorders, will be applied topically twice a day for 12 weeks. The study is expected to conclude in the first quarter of 2003.

• PharmaStem Therapeutics Inc., of Wayne, Pa., and Anthrogenesis Corp., of Cedar Knolls, N.J., entered an agreement for Anthrogenesis to obtain a license to PharmaStem's patent portfolio. PharmaStem is the successor to Biocyte Corp., also involved in the development of umbilical cord and placental blood preservation and its therapeutic use. PharmaStem has received three U.S. patents to date, the first issued in 1991. Other patent applications are pending. On Nov. 13, Anthrogenesis announced that it signed a definitive agreement to be acquired by Celgene Corp., of Warren, N.J., for $45 million. (See BioWorld Today, Nov. 15, 2002.)

• Serono SA, of Geneva, and Pfizer Inc., of New York, said their multiple sclerosis therapy, Rebif (interferon beta-1a), was shown to be more effective than Avonex (interferon beta-1a) in reducing relapses and active brain lesions in patients with relapsing remitting MS over 24 and 48 weeks, according to data published in the current edition of Neurology. The Evidence study, which involved 677 patients with relapsing remitting MS, was designed to compare the proportion of MS patients treated with either Rebif or Avonex who were relapse-free after 24 (primary endpoint) and 48 weeks. The data show that 75 percent of patients who received Rebif did not have a relapse after 24 weeks compared to 63 percent of patients treated with Avonex.

• Symyx Technologies Inc., of Santa Clara, Calif., completed the delivery and installation of a Polymorph Discovery Tools System to Merck & Co. Inc., of Whitehouse Station, N.J. The Polymorph System is a high-throughput integrated workflow designed to rapidly identify optimal crystalline salt and polymorphic forms of drug candidates.

• Unigene Laboratories Inc., of Fairfield, New Jersey, said the indications for its injectable calcitonin product, Forcaltonin, will be expanded in the 15 member states of the European Union to include use in the prevention of bone loss associated with osteoporotic fractures. Forcaltonin was previously approved for Paget's disease and hypercalcemia of malignancy.