¿ Alexion Pharmaceuticals Inc. and Yale University School of Medicine, both of New Haven, Conn., said scientists discovered that elevations in harmful complement activation in patients with congestive heart failure are associated with worse clinical symptoms and a reduced rate of event-free survival at six months. Alexion¿s C5 complement inhibitor humanized monoclonal antibody, 5G1.1, blocks the production of harmful complement components, the company said.
¿ Amersham Pharmacia Biotech, of Piscataway, N.J., joined the SNP (single nucleotide polymorphism) Consortium to map human genetic diversity as a means of finding new ways to fight disease. The company joins the Wellcome Trust, 10 pharmaceutical companies, Motorola Inc. and IBM in the two-year, $53 million initiative.
¿ Amrad Corp. Ltd., of Victoria, Australia, and DevCo Pharmaceuticals, of Guilford, UK, agreed to license an early stage pharmaceutical project that has potential as a treatment of stroke. The agreement involves the development of Amrad¿s AM36, a novel compound with combined antioxidant and neuronal sodium channel blocking actions.
¿ Anesta Corp., of Salt Lake City, said it renegotiated the U.S. marketing rights for Actiq (oral transmucosal fentanyl citrate) with Abbott Laboratories, of Abbott Park, Ill. Anesta now will have primary responsibility for the sale and marketing of Actiq in the U.S., but Abbott will continue to manufacture and distribute the product. Actiq was launched in March 1999.
¿ Atugen AG, of Berlin, and Axys Pharmaceuticals Inc., of South San Francisco, signed a research collaboration agreement to provide gene target validation services through the Atugen USA subsidiary. Axys will provide Atugen with gene targets in oncology and Atugen will develop GeneBloc reagents. Financial terms were not disclosed.
¿ Avant Immunotherapeutics Inc., of Needham, Mass., said the FDA granted orphan drug status to Avant¿s lead complement inhibitor, TP10, as a potential treatment to reduce the consequences of reperfusion injury and to improve post-operative outcomes in infants undergoing cardiac surgery.
¿ COR Therapeutics Inc., of South San Francisco, said Integrilin (eptifibatide) injection reduced the combined incidence of death, heart attack, need for urgent repeat intervention, or the need for thrombotic bail-out therapy from 10.5 percent with placebo to 6.6 percent over the 48 hours following non-urgent balloon angioplasty combined with intracoronary stenting. Integrilin also reduced the combined occurrence of death and heart attack at 48 hours from 9.2 percent to 5.5 percent, a statistically significant reduction.
¿ CV Therapeutics Inc., of Palo Alto, Calif., said Phase I results of CVT-510 indicate the compound may be a potential therapeutic option for immediate and sustained control of rapid heart rate with minimal effects on blood pressure or normal heart rates. The data show that CVT-510 may slow the heart rate by selectively targeting the adenosine A1 receptor. The company plans to confirm the findings in a Phase II trial in patients with atrial arrhythmias.
¿ CytRx Corp., of Atlanta, said it plans to proceed with the development of Flocor, purified poloxamer 188, for the treatment of sickle cell disease. The company said in December that Phase III results showed benefits, but did not achieve significance in the primary endpoint. The company has conducted additional analysis of the Phase III data. (See BioWorld Today, Dec. 22, 1999, p. 1.)
¿ D-Pharm Ltd., of Rehovot, Israel, and Shire Pharmaceuticals Group plc, of Andover, England, signed a license agreement for Shire to exclusively develop and market DP-VPA, which Shire has designated SPD 421. It is a new chemical analogue of valproic acid used for treatment of epilepsy, bipolar disorder and migraine prophylaxis. It has completed Phase I studies. The deal includes an up-front fee and clinical and commercial milestone payments. D-Pharm retains manufacturing rights, and Shire will be responsible for development and registration activities.
¿ Dynavax Technologies, of Berkeley, Calif., said positive results demonstrated that its immunostimulatory sequence (ISS) is active in reducing the frequency and severity of disease symptoms in treatment models of HSV-2. The application of the ISS compound in mice delayed the onset of and reduced the number of animals that developed signs of disease, and increased survival when compared to controls.
¿ Elan Corp., of Dublin, Ireland, plans to begin a Phase I multiple-dose study in the UK of Betabloc, its new agent to treat Alzheimer¿s disease, within the next few weeks. In preclinical studies, Betabloc prevented the buildup and reduced the level of amyloid plaque in the brains of mice engineered to replicate the plaque deposits that characterize Alzheimer¿s disease.
¿ Interleukin Genetics Inc., of San Antonio, said data demonstrated that individuals with specific variations in the interleukin-1 genes have an 81 percent increased risk of requiring retreatment after angioplasty procedures. The data were compiled from 1,850 patients who underwent coronary stent placement to reopen blocked coronary arteries.
¿ Kinetek Pharmaceuticals Inc., of Vancouver, British Columbia, along with the BC Cancer Agency said research has found a key link between PTEN, a tumor-suppressor gene, and ILK, an enzyme that plays a central role in controlling cellular functions associated with tumor growth and migration. The research shows that highly selective small-molecule inhibitors of ILK can block cancer cell migration, survival and growth. The findings are published in the March 14 issue of Proceedings of the National Academy of Sciences.
¿ LifeCell Corp., of Branchburg, N.J., agreed to donate its tissue transplant product, AlloDerm, for procedures conducted under the auspices of the American Academy of Facial Plastic and Reconstructive Surgery program, called Face to Face: The National Domestic Violence Project. AlloDerm is human tissue that has been chemically processed to remove all epidermal and dermal cells, while preserving the remaining bioactive dermal matrix necessary for normal tissue regeneration.
¿ Neurocrine Biosciences Inc., of San Diego, said the Neurocrine GnRH small-molecule antagonist program accomplished two significant milestones. The company said it developed small-molecule GnRH antagonist compounds for the treatment of endometriosis, uterine fibroids, prostate/breast cancer and other related diseases and plans to be in clinical trials within a year. The company also was awarded a National Institutes of Health Phase I grant supporting research and development efforts.
¿ Nymox Pharmaceutical Corp., of Kensington, Md., completed a private placement with an institutional investor of 666,667 shares and 66,667 warrants for total proceeds of $4 million. The new equity was placed by Ladenburg Thalmann & Co., of New York.
¿ Palatin Technologies Inc., of Princeton, N.J., said it pulled away from its merger plans with Molecular BioSystems Inc., of San Diego. The companies announced the planned stock-swap deal in November and planned to close MBI¿s operations in San Diego and lay off most of those employees. Palatin management was unavailable for comment. Its press statement noted only that the merger is not ¿currently in the best interests of its stockholders.¿ (See BioWorld Today, Nov. 15, 1999, p. 1.)
¿ Quorex Pharmaceuticals Inc., of Carlsbad, Calif., completed a $2.2 million seed financing. The funding included a $1.1 million financing last October. It enables the company to accelerate discovery and development of antibiotics to treat serious bacterial infections, including those resistant to existing drugs.
¿ SignalGene Inc., of Montreal, completed its acquisition of GeneScape Inc., of Mississauga, Ontario, with the exchange of 6.6 million new common shares. Before the closing, GeneScape had received C$2.7 million (US$1.84 million) in new private placement funds from Business Development Bank of Canada and Royal Bank Venture Inc. After the closing, SignalGene received from Societe Innovatech du Grand Montreal a private financing of C$1 million.
¿ Sonus Pharmaceuticals Inc., of Bothell, Wash., said it received an action letter from the FDA that extended the approvable status of EchoGen (perflenapent injectable emulsion), the company¿s first ultrasound contrast agent. The company had received an approvable letter for EchoGen in April 1999. In the new action letter, the FDA is requesting a reanalysis of certain data that may affect product labeling.
¿ Third Wave Technologies Inc., of Madison, Wis., said a group working with geneticist John Todd at Cambridge University showed the patented Invader operating system to be more accurate and cheaper than conventional genotyping methods for high-throughput DNA analysis. Results of the study were published in the March issue of Genome Research.
¿ Trimeris Inc., of Durham, N.C., and Hoffmann-La Roche Inc., of Nutley, N.J., started dosing in a Phase II study that will evaluate alternative formulations of the HIV fusion inhibitor T-20. The multicenter, open-label study is investigating safety, tolerability and pharmacokinetics of two formulations of T-20 in treatment-experienced, HIV-infected patients. The trial is designed to enroll up to 60 patients.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., said the redemption period of its Class A warrants expired on March 10. Of the 1.19 million outstanding warrants, about 90 percent were exchanged for 1.07 million shares of common stock and 1.07 million Class B warrants. Their exercise resulted in net proceeds of about $4.71 million.
¿ Xenometrix Inc., of Boulder, Colo., granted a license for its Yeast DEL technology to Pfizer Inc., of New York, giving Pfizer access to claims that cover the measurement of the genotoxic potential of compounds using proprietary Yeast DEL strains.