• Advanced Tissue Sciences Inc., of La Jolla, Calif., said board members reported a unanimous decision to undertake an orderly liquidation of the company's assets. The decision resulted from a previously reported review of alternatives for restructuring, following the filing for reorganization under Chapter 11 of the U.S. Bankruptcy Code last month. The company also reported the resignations of Arthur Benvenuto, who was chairman, president and CEO, and Gail Naughton, who was vice chairman. Additionally, about 12 of the company's remaining employees were released. (See BioWorld Today, Oct. 14, 2002.)

• Advanced Viral Research Corp., of Yonkers, N.Y., said it initiated the single-dose safety study that is the first phase of three Product R trials in Israel. It retained the Israeli unit of Research Triangle Park, N.C.-based Quintiles Transnational Corp. to monitor and audit the trials according to FDA standards. EnviroGene LLC, an affiliate of the Selikoff Center for Environmental Health and Human Development in Israel, will conduct the trials. The company said the product for the trials was produced following FDA cGMP guidelines in its plant in Yonkers. The trials are designed to move "Product R into clinical use as quickly as possible," the company said. Last week the company said it was reducing staff and selling a manufacturing facility in the Bahamas in order to focus on the trials in Israel. The trials will evaluate Product R for safety and toxicity, while also monitoring its effect on cachexia. Possible salvage effects also will be investigated. (See BioWorld Today, Nov. 11, 2002.)

• Biogen Inc., of Cambridge, Mass., said the FDA approved a label change for Avonex, lowering the rate of occurrence of neutralizing antibodies to 5 percent from the original label rate of 24 percent. Recent studies with multiple sclerosis patients given Avonex for at least 1 year showed the presence of neutralizing antibodies at the rate of 5 percent. The clinical significance of neutralizing antibodies to Avonex is unknown, the company said.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., said it received from Solvay Pharmaceuticals BV, of Brussels, Belgium, a $950,000 clinical milestone payment related to a license of BioSante's Bio-E/P-Gel topical hormone therapy. BioSante may receive additional milestone and royalty payments, given U.S. and Canadian regulatory approval for the gel, which combines estradiol (the bioidentical human estrogen) and progestogen to treat menopausal symptoms in women.

• Cell Therapeutics Inc., of Seattle, said positive data from studies of its drug, Xyotax, in women with recurrent ovarian cancer were presented at the Chemotherapy Foundation meeting in New York. Results also indicate that Xyotax may have fewer and less-severe side effects when compared to paclitaxel. The U.S.-based Phase II trial showed that Xyotax (175mg/m2 every three weeks) given as a 10-minute infusion was well tolerated without requiring premedication in all but a few patients. In the pretreated patient cohort, grade 4 neutropenia, neuropathy or fatigue was reported in two patients (2 percent). Only one patient had hair loss. The drug was well tolerated with patients receiving as many as 12 cycles (40 weeks) of therapy without dose-limiting toxicities. Separately, Cell Therapeutics entered into a partnership with the nonprofit Hope Heart Institute in Seattle to research potential cancer targets. Cell Therapeutics will pay the institute a minimum of $15,000 per month for research support, and will grant the institute warrants to purchase 100,000 shares of common stock at $10 each in exchange for an exclusive license to all oncology and supportive care-related research and first right of refusal on all other technology useful in the fields of oncology and supportive care. The institute will retain rights to use the technologies for cardiovascular disease research.

• Durect Corp., of Cupertino, Calif., and Thorn BioScience LLC, of Lexington, Ky., expanded their agreement for the development and commercialization of veterinary products for reproductive indications using Durect's Saber delivery system. Durect granted Thorn an exclusive, worldwide license to use the Saber delivery system to provide a sustained-release therapy for reproductive indications for specified animal species. Thorn also will have rights to growth-promotion indications for certain drug classes and for specified animal species. Thorn committed to develop multiple products with the technology, Durect said. Financial terms were not disclosed.

• Evotec OAI AG, of Hamburg, Germany, and the venture firm Oxford Bioscience Partners, of Boston, entered a drug discovery and development partnership to benefit OBP's portfolio companies. OBP will promote Evotec as a preferred provider of integrated drug discovery and development sciences to its portfolio companies. OBP affiliates will gain access to dedicated resources that can be applied to any biology and/or chemical services provided by Evotec to accelerate the respective OBP affiliates' drug discovery programs.

• Fluidigm Corp., of South San Francisco, raised additional Series C funding from Lilly BioVentures. The investment is in addition to the previously announced $37 million invested by the Lehman Brothers Healthcare Fund, Euclid SR Partners, Piper Jaffray Ventures, GE Equity, InterWest Partners and Versant Ventures. The proceeds will be used primarily for Fluidigm's first product for protein crystallization. The company is focused on microfluidics, through the commercialization of complete and enabling microfluidic systems.

• Gene Network Sciences, of Ithaca, N.Y., said it launched VisualCell, a data integration platform and drawing software toolkit that enables large-scale cellular modeling. VisualCell combines cell-drawing tools with standard annotations.

• GenStar Therapeutics Corp., of San Diego, is restructuring its operations to reduce expenses and concentrate its resources on the later-stage cardiovascular products that will be the focus of the company when it completes the planned merger with Vascular Genetics Inc., of Atlanta. GenStar said it reduced by 30 percent its research and administrative staff of about 45 employees. It also plans to consolidate all its operations into its Barnes Canyon facility. GenStar expects the moves to reduce cash expenditures by $200,000 a month. The companies also said they intend to enter a services agreement for the VEGF-2 product for refractory angina, which will be the lead product for the merged company. The merger is expected to close in the first quarter of 2003 and the company will be named CorAutus Genetics Inc. (See BioWorld Today, Sept. 16, 2002.)

• GenVec Inc., of Gaithersburg, Md., began a Phase II trial of its lead oncology product candidate, TNFerade, as part of first-line therapy in patients with non-metastatic esophageal cancer. About 55 patients at 13 sites throughout the U.S. will participate in the study. TNFerade will be added to the current standard of care, which is a chemotherapeutic regimen of cisplatin/5FU and radiation therapy followed by surgery.

• ICOS Corp., of Bothell, Wash, and Eli Lilly and Co., of Indianapolis, said the European Commission granted marketing approval for Cialis, an oral PDE5 inhibitor for the treatment of erectile dysfunction, for the European Union. Lilly ICOS LLC, the joint venture between ICOS and Lilly, expects to launch the product in the first half of 2003. Lilly ICOS filed a Cialis new drug application in the U.S. in June 2001. The joint venture received an approvable letter in April, in which the FDA requested confirmatory clinical pharmacology studies, as well as a resolution to labeling issues and outstanding manufacturing deficiencies at Lilly. Company officials also expect the U.S. launch to be in 2003. (See BioWorld Today, June 29, 2001, and May 1, 2002.)

• KuDos Pharmaceuticals Ltd., of Cambridge, UK, acquired from Cancer Research Technology Ltd. and Cancer Research UK a worldwide license to PaTrin-2 (4-bromothenylguanine). KuDos will begin during the first quarter of next year Phase II studies of PaTrin-2 administered in combination with temozolomide. Earlier clinical work showed the combination to be well tolerated and established a dose of PaTrin-2 that effectively inhibited the enzyme alkylguanine alkyltransferase. Financial terms were not disclosed.

• Lorus Therapeutics Inc., of Toronto, reported that Mayne Pharma, previously called Faulding Pharmaceuticals Inc., a division of F.H. Faulding & Co. Ltd., of Melbourne, Australia, will exercise its option to acquire distribution rights for Virulizin in Argentina for the treatment of malignant melanoma. The distribution agreement will include the same terms as the exclusive seven-year distribution agreement signed between Lorus and Mayne in October 2001 for Mexico.

• Maxygen Inc., of Redwood City, Calif., said it is reducing operating expenses and focusing its efforts on advancing therapeutic products. Maxygen is eliminating about 30 positions, or 10 percent of the company's worldwide staff, leaving it with about 285 employees. As of Oct. 1, Maxygen had a cash position of $238.6 million, of which approximately $25 million was controlled by the company's majority-owned subsidiary, Codexis Inc. The company expects to recognize a one-time total charge of approximately $800,000 in 2002, primarily associated with involuntary termination benefits. The company anticipates a burn rate of approximately $30 million for 2002, including the one-time charge.

• Milkhaus Laboratory Inc., of Providence, R.I., said an open-label Phase II trial of its product, ML-04, for the treatment of chronic prostatitis, is fully enrolled. The trial is being conducted at the Stanford University School of Medicine. Final results are expected in January.

• NeoPharm Inc., of Lake Forest, Ill., unveiled preclinical data for two products using its Neolipid liposomal technology, at the 2002 American Association of Pharmaceutical Scientists annual meeting and exposition in Toronto. NeoLipid liposomal technology is designed to create a liposome that combines a potent cancer drug with NeoPharm's lipids in an effort to reduce the toxicity of the drug as well as to enhance its stability with the goal of creating a safer, more tolerable cancer treatment. At AAPS, NeoPharm presented preclinical data on two of its NeoLipid agents, LE-SN38 (liposomal SN38) and LEM (liposomal mitoxantrone).

• NexMed Inc., of Robbinsville, N.J., said the FDA advised it to stop the ongoing open-label study of the Alprox-TD cream for erectile dysfunction until resolving certain issues surrounding NexMed's 26-week transgenic mouse study. The agency, which is permitting NexMed to complete by next month its two fully enrolled Phase III pivotal studies of Alprox-TD, based its decision on data showing that permeation excipient formulated in Alprox-TD, the penetration-enhancement agent, was associated with an increase in benign dermal papillomas at the highest concentrations tested in the mouse study. NexMed said the results were negative at the lowest concentration tested, adding that active drug was not used in the mouse study and therefore does not suggest a safety issue with alprostadil. NexMed's stock (NASDAQ:NEXM) fell 58.4 percent Thursday, or 80 cents, to close at 57 cents.

• Onyx Pharmaceuticals Inc., of Richmond, Calif., updated several aspects of its company. BAY 43-9006, an orally active small-molecule raf kinase inhibitor anticancer agent, is moving toward Phase III trials in 2003, it said. Onyx also said the FDA approved an amendment filed to the chemistry, manufacturing and controls section of its investigational new drug application for ONYX-015, allowing the company to use product manufactured at XOMA LLC on a larger scale. Also, the company reiterated that it is seeking a partner for its therapeutic virus program - including the lead product candidate in this program, ONYX-015 - in order to reduce its burn rate.

• Ortec International Inc., of New York, closed an $8.7 million private placement financing, including participation from both new and existing institutional investors. Between May and October, Ortec received $5.5 million in gross proceeds through the issuance of convertible notes and preferred shares. Since Nov. 1, Ortec has received an additional $2.7 million in gross proceeds from participating investors. Ortec is a tissue-engineering company involved in a technology to stimulate the repair and regeneration of human tissue