• Alkermes Inc., of Cambridge, Mass., said results of a Phase III extension study of Vivitrex (naltrexone long-acting injection) in alcohol-dependent patients show that the drug plus counseling led to a sustained reduction in heavy drinking over an 18-month period. The trial included 332 patients - about 85 percent of the subjects enrolled in the initial six-month study - who received Vivitrex in 380-mg or 190-mg doses. Those who continued on active treatment with 380 mg demonstrated a sustained reduction in levels of heavy drinking. The median number of heavy drinking days on Vivitrex treatment in the main trial was similar to the number during the 12-month extension study, 2.6 days and 1.6 days per month, respectively. Findings were presented at the American Psychiatric Association annual meeting in Atlanta. Alkermes announced earlier this year that it had filed a new drug application with the FDA for Vivitrex, administered as a once-monthly injection, to treat alcoholism. (See BioWorld Today, April 4, 2005.)

• Alteon Inc., of Parisppany, N.J., said data from the initial group of patients in a Phase IIa study on endothelial function and vascular compliance demonstrated that its drug, alagebrium, increased arterial elasticity through the breaking of A.G.E. crosslinks and improves endothelial function. The results recently were presented at the American Geriatrics Society 2005 annual meeting and at the 11th Annual Scientific Session of the Society of Geriatric Cardiology, both held in Orlando, Fla.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said its partner, Natick, Mass.-based Boston Scientific Corp., received FDA approval extending the shelf life of BSC's Taxus Express (2) paclitaxel-eluting coronary stent system in the U.S. from nine months to 12 months. BSC said the decision was based on data that demonstrated that the performance of the Taxus system, including drug content, drug degradation profile and drug-release mechanism, was maintained within FDA-approved specifications.

• Arginox Pharmaceuticals, of Menlo Park, Calif., said the FDA granted orphan drug designation to Tilarginine Acetate Injection for the treatment of cardiogenic shock. The company expects to begin enrolling patients in the Phase III TRIUMPH (Tilarginine Acetate for Injection in a Randomized International Study in Unstable AMI Patients with Cardiogenic Shock) trial later this month.

• BioXell SpA, of Milan, Italy, signed an exclusive, worldwide license agreement with Whitehouse Station N.J.-based Merck & Co. Inc. for the development of TREM-related therapeutic and diagnostic products. Under the agreement, Merck obtains rights to develop BioXell's initial product candidate directed to TREM (triggering receptors expressed on myeloid cells)-1, which is in preclinical studies, as well as other candidates directed to the TREM-1 target. The companies also will collaborate on further research of other TREM receptors. BioXell will receive an up-front payment and could receive as much as $150 million in milestone payments, including $55.5 million for the development of the first product. Merck will handle clinical development and commercialization, while BioXell retains rights to royalties.

• Callisto Pharmaceuticals Inc., of New York, intends to evaluate Atiprimod in patients with myelodysplastic syndrome. It is in a Phase I/IIa trial in refractory or relapsed multiple myeloma patients at four clinical sites in the U.S., and in a Phase I/IIa trial in advanced cancer patients at the University of Texas M.D. Anderson Cancer Center. The protocol for the MDS trial is being finalized.

• Cellegy Pharmaceuticals Inc., of Brisbane, Calif., received notification from rhe Nasdaq Stock Market that the company regained compliance with the standards for continued listing of its common stock. Cellegy develops and commercializes prescription drugs for the treatment of women's health care conditions.

• Cellzome Inc., of Boston, said Ortho-McNeil Pharmaceutical Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, exercised its option to license and develop Cellzome's Gamma Secretase Modulator program, under the terms of the companies' collaboration signed in March. The program includes identifying new medicines to treat Alzheimer's disease. Terms call for Cellzome to receive an additional technology access fee and continued research funding to deliver clinical drug candidates to Ortho-McNeil.

• Corgenix Medical Corp., of Denver, completed a private placement with selected institutional and accredited investors, raising up to about $5.1 million. The placement consists of $3.4 million in senior convertible term notes due 2008; $215,000 in common stock subscriptions; and the potential for up to $1.5 million in an additional investment, which could be exercised for up to 270 days following the closing. The company will use proceeds to refinance existing debt, and for key initiatives, working capital and other general corporate purposes. Ascendiant Securities LLC and Burnham Securities Inc. served as placement agents.

• CoTherix Inc., of San Diego, said researchers presented results involving inhaled iloprost therapy to treat pulmonary arterial hypertension at the American Thoracic Society International Conference in San Diego. The data demonstrated the long-term safety and efficacy of inhaled iloprost in NYHA Class III and IV patients and support intermittent dosing. Ventavis was approved by the FDA in December.

• Cylex Inc., of Columbia, Md., said results from five recent clinical studies verify the clinical use of ImmuKnow, the company's biomarker product, demonstrating how ImmuKnow improves therapeutic outcomes for transplant patients by helping to guard against acute rejections and infections. Cylex said the results will be presented during the American Transplant Congress annual meeting in Seattle this week.

• CytRx Corp., of Los Angeles, said an investigational new drug application for arimoclomol to treat amyotrophic lateral sclerosis has been filed with the FDA. The company expects to start a Phase II trial in June.

• Encysive Pharmaceuticals Inc., of Houston, said investigators presented six posters on Thelin (sitaxsentan) in pulmonary arterial hypertension at the Annual International Conference of the American Thoracic Society in San Diego. Additional data from its STRIDE-2 trial of Thelin (sitaxsentan) in pulmonary arterial hypertension showed that patients on Thelin 100 mg appeared to continue improving from week 12, while those taking bosentan trended down beyond the 12th week. The company announced in February that the drug met its primary endpoint of improved six-minute walk distance. Thelin also improved WHO functional class vs. placebo, while bosentan did not, and showed a benefit over both placebo and bosentan in time to first clinical worsening. (See BioWorld Today, Feb. 15, 2005.) Another study showed that non-placebo trials generally produce larger treatment effects than seen in placebo trials, while another study showed there was no clinical interaction between Thelin and Viagra. A third study highlighted sustained efficacy after two years of Thelin therapy in patients with PAH.

• EPIX Pharmaceuticals Inc., of Cambridge, Mass., submitted a response to the FDA's approvable letter received in January for MS-325, the first in a class of MRI blood pool contrast agents designed for magnetic resonance angiography. The FDA asked for additional information relating to the non-contrast MRA comparator scans used in the clinical trials and the statistical treatment of uninterpretable images, and also requested additional clinical studies to demonstrate efficacy. In its response, EPIX provided new analyses of those issues, but did not include efficacy data from new trials. (See BioWorld Today, Jan. 18, 2005.)

• Genitope Corp., of Redwood City, Calif., signed leases for its commercial manufacturing facility and new corporate headquarters. The facility will be located in Fremont, Calif. Genitope is focused on the research and development of immunotherapies for the treatment of cancer.

• Geron Corp., of Menlo Park, Calif., obtained clearance from the FDA to initiate clinical testing of its lead cancer compound, GRN163L, in patients with chronic lymphocytic leukemia. The company filed its investigational new drug application in April. Geron will begin treating patients next month, administering GRN163L on a weekly intravenous dosing schedule.

• ImVisioN GmbH, of Hanover, Germany, appointed Martin Steiner CEO. Steiner previously was CEO and founder of Apovia AG and EVAX Technologies AG. The company also reported that recently it initiated its operations as an independent biotechnology company focused on the development of immunotherapeutics based on its Modular-Antigen-Transport technology to treat allergic diseases. The company's lead product, IVN201, an immunotherapeutic to treat cat dander allergy, is expected to enter clinical trials in early 2006.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., said data show that Sanctura (trospium chloride) not only assists in controlling symptoms of overactive bladder when taken orally, but it also controls symptoms when local contact is made with the bladder wall. The data were presented at the American Urological Association annual meeting in San Antonio on Sunday from a preclinical study conducted by a University of Pittsburgh researcher. Sanctura is indicated to treat overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency.

• Insense Ltd., of Bedford, UK, said results on Oxyzyme, a product in development to treat chronic wounds, showed improvement and healing of about two-thirds of the wounds treated, including some that had been present for more than a year, within four weeks. The Oxyzyme system is contained within a hydrogel dressing and is designed to clean the wound, produce oxygen and release small amounts of iodine to kill bacteria and other microbes.

• Institute for OneWorld Health in San Francisco said it has received orphan drug designation from the FDA and the European Agency for the Evaluation of Medicinal Products for paromycin to treat visceral leishmaniasis. OneWorld Health expects to file for approval of paromycin in India this year.

• Inverness Medical Innovations Inc., of Waltham, Mass., said its subsidiary, Wampole Laboratories LLC, signed an agreement with ThyroTec Inc., of Honey Brook, Pa., to serve as the exclusive North American distributor of ThyroTest, an immunoassay screen for hypothyroidism. Financial terms were not disclosed.

• Lilly ICOS LLC, the joint venture between Indianapolis-based Eli Lilly & Co. and Bothell, Wash.-based ICOS Corp., said data from an open-label trial showed Cialis (tadalafil) improved erections in more than three-quarters of men suffering from erectile dysfunction and one or more other condition, such as cardiovascular disease, diabetes, depression, hyperlipidemia and prostate disease. On average, nearly 50 percent of all attempts resulted in an erection when patients were treated with Cialis 20 mg, compared to about 17 percent at baseline. These results were presented at the 100th annual meeting of the American Urological Association.

• Matritech Inc., of Newton, Mass., said researchers analyzed 298 samples using experimental versions of a colorimetric sandwich immunoassay and qualitative reverse transcriptase polymerase chain reaction (RT-PCR) to detect the NMP66 protein complex in the blood of women with breast cancer. RT-PCR identified more than 70 percent of the cancer sera, and the colorimetric assay demonstrated good differentiation of non-cancer samples. Among postmenopausal women, those with positive colorimetric assay values were 70 percent more likely to have cancer than those with negative test values.

• MultiCell Technologies Inc., of Lincoln, R.I., said its licensee, XenoTech LLC, executed a three-year use and propagation agreement with New York-based Bristol-Myers Squibb Co. The agreement calls for BMS to use MultiCell's immortalized non-tumorigenic human Fa2N-4 hepacytes for internal testing purposes. Financial terms were not disclosed.

• NexMed Inc., of Robbinsville, N.J., said preliminary results from a 400-patient at-home study of Femprox conducted in China showed demonstrable improvement in sexual arousal. At the end of the first evaluation period, the highest dose of Femprox had an improvement in mean arousal success rate from baseline of 38.7 percent, compared with 17 percent for placebo. The multicenter, randomized, double-blind, placebo-controlled study was designed to test three strengths of Femprox cream in pre-menopausal and post-menopausal women diagnosed with female sexual arousal disorder. Data were presented at the Annual Meeting of the American Urological Association in San Antonio.

• Ortec International Inc., of New York, and Hapto Biotech Inc., of Jerusalem, reported positive preclinical in vivo results generated through their joint venture, established to combine Ortec's and Hapto's technologies to develop a non-cellular biologically active enhanced collagen biomaterial to promote the attraction and attachment of healthy cells for application to the wound healing, reconstructive, cosmetic, orthopedic, tissue regeneration and dental markets. The results of the animal studies showed that Ortec's collagen sponge scaffold modified by attachment of Hapto's peptides had a higher cell-binding potential than untreated collagen.

• Oxagen Ltd., of Abingdon, UK, completed a $59.8 million Series B round, led by MPM Capital LP, of Boston. Proceeds are expected to advance the company's lead program, a small-molecule anti-inflammatory for asthma, to the clinic, and to expand its clinical and preclinical-stage portfolio. Existing investors SV Life Sciences, Advent Ventures, 3i plc, Abingworth and The Wellcome Trust, all of London, also participated in the round. Luke Evnin and Ed Mascioli, both of MPM Capital, will join Oxagen's board. Oxagen is building a drug pipeline with a focus on the GPCR family of targets.

• Sequenom Inc., of San Diego, said data indicate the involvement of the intercellular adhesion molecule gene, ICAM1, in breast cancer metastasis. It is the first study to report that ICAM1 likely plays a major role in the invasion of cancerous cells and in the growth and metastasis of breast tumors. The study, published in the May 23, 2005, issue of Carcinogenesis, corroborates Sequenom's previous findings that genetic variations in the ICAM gene region are associated with metastases and establish a causal role of ICAM1 in invasion of metastatic human breast cancer cell lines.

• Serono SA, of Geneva, said data from a clinical trial of Raptiva showed that, with three years of continuous treatment, 73 percent of moderate to severe psoriasis patients achieved improvement of 75 percent or greater, according to the Psoriasis Area Severity Index. A second study, the CLEAR trial, showed that high-need patients benefit equally well from Raptiva. Results were presented at the 3rd Spring Symposium of the European Academy of Dermatology and Venereology in Sofia, Bulgaria.

• SRI International, of Menlo Park, Calif., said the National Institute of General Medicals Sciences, a unit of the National Institutes of Health, has continued a grant to support the modeling of complex mammalian signaling networks based on signaling of the epidermal growth factor receptor using SRI's Pathway Logic analysis software. In the project's first phase, SRI demonstrated a computational approach to help researchers create, analyze and test models of complex EGFR signaling networks, and the company is expected to increase the use and predictive capabilities of the technology in the second phase.

• Tapestry Pharmaceuticals Inc., of Boulder, Colo., began dosing in its Phase I trial of TPI 287, a taxane designed to overcome the resistance that can develop in patients refractory to available taxanes. The trial is an open-label, multicenter, dose-escalation study, designed to evaluate the safety and pharmacokinetic profile of the compound in eligible patients with recurrent and/or refractory malignancies. The trial is designed to enroll about 48 patients.

• Tercica Inc., of South San Francisco, said the High Court in London issued rulings in Tercica and South San Francisco-based Genentech Inc.'s favor, denying motions attacking the companies' patent relating to insulin-like growth factor-1 and insulin-like growth factor-3. Insmed Inc., of Richmond, Va., and Avecia Ltd., of Billingham, UK, had made motions for summary judgment in the matter. Tercica's suit in the UK alleges that by making and selling SomatoKine for the treatment of growth hormone insensitivity syndrome, Avecia and Insmed infringe on a European patent under which Tercica holds an exclusive license from Genentech. The court also ordered Insmed and Avecia to pay Tercica's and Genentech's legal fees.

• ViroLogic Inc., of South San Francisco, said it was added to the Nasdaq Biotechnology Index effective at the market's open on Monday. ViroLogic is working to advance individualized medicine through products to improve treatment of infectious diseases and cancer.

• Vivus Inc., of Mountain View, Calif., said a six-month study of its urethrally administered erectile dysfunction suppository MUSE (alprostadil) in patients who have undergone a bilateral nerve-sparing radical prostatectomy showed that 39 percent of the treatment group were able to achieve natural erections at the end of the study, compared to 11 percent of patients in the control group. MUSE was approved in 1997 for the treatment of erectile dysfunction. Results of the study were presented at the annual meeting of the American Urological Association in San Antonio. Vivus also presented results of a Phase II trial of Alista (topical alprostadil), an investigational treatment for female sexual arousal disorder in premenopausal women, that demonstrated 64 percent of women given Alista resulted in satisfactory sexual events compared to placebo.