¿ Acadia PharmacoGenomics, of San Diego, said new genomic information has revealed a high frequency of genetic variation, estimated at one difference in every 500 base pairs, meaning changes in the encoded proteins of drug targets are likely to be very common in human populations. Acadia said results of its studies show that genetic variation can have profound effects on pharmacology and function, and in some cases it can prevent or enhance a drug response or cause targets to signal even without stimulation by their native ligand.
¿ Amrad Corp. Ltd., of Victoria, Australia, said it has produced significant quantities of VEGF-B (vascular endothelial growth factor B) protein - or AM133 - a potential treatment for cardiovascular disease. The company has received its first milestone payment from partner Edwards Life Sciences as a result. The agreement with Edwards, formerly the cardiovascular group of Baxter Healthcare Corp., of Deerfield, Ill., provides for Amrad and the Ludwig Institute for Cancer Research to share up to US$22 million, which encompasses license fees and milestone payments, in addition to any royalties.
¿ Aronex Pharmaceuticals Inc., of The Woodlands, Texas, said it is preparing an amendment to the existing new drug application (NDA) for Atragen that will be based on more than 100 patients instead of the 56 included in the original filing. The additional clinical data will be added to comparative pharmacokinetics data of Atragen vs. oral Atra, along with a number of supporting expert reports from opinion leaders in the field of leukemia. In September, the FDA advised the company of deficiencies in its December 1998 NDA of Atragen for acute promyelocytic leukemia patients who are unable to take oral Atra. The company expects to complete the filing by mid-year. Aronex also said it intends to move forward with filing an NDA for Nyotran as a treatment for patients with confirmed Aspergillus and Candida infections that have not responded to prior treatments. In February, Nyotran failed to meet its primary endpoint in a Phase III study in patients with confirmed cryptococcal meningitis. (See BioWorld Today, Sept. 28, 1999, p. 1; and Feb. 17, 2000, p. 1.)
¿ Biomira Inc., of Edmonton, Alberta, said a U.S. Data Safety Monitoring Board recommended the company continue with its Phase III trial of Theratope vaccine for metastatic breast cancer after it reviewed data from the first 300 patients who completed the first 12 weeks of therapy. The study now is ongoing at more than 115 clinical sites in North America, Europe, Australia and New Zealand. It is steadily accruing patients, with about 480 enrolled so far.
¿ Biosyn Inc., of Philadelphia, said an investigational study of Oramed, an oral rinse treatment for oral candidiasis, showed positive results in a population of HIV/AIDS patients. Results of the randomized, placebo-controlled, Phase I/II study showed that Oramed was safe and well tolerated among HIV/AIDS patients. It also demonstrated early signs of efficacy compared with the placebo.
¿ Cantab Pharmaceuticals plc, of Cambridge, UK, said it received from Yale University a $750,000 U.S. National Institute on Drug Abuse grant to advance the development of its novel anti-cocaine vaccine, TA-CD. A Phase IIa trial of TA-CD has been initiated in the U.S. Up to 20 patients undergoing treatment for cocaine addiction on an outpatient basis are enrolled. The grant also supports a cocaine challenge study of TA-CD in up to 10 patients at Columbia University.
¿ Cell Genesys Inc., of Foster City, Calif., said collaborators at Johns Hopkins University found that GVAX cancer vaccine, administered in animals with acute leukemia following bone marrow transplantation, significantly prevented tumor relapse and increased the therapeutic benefit of transplantation. Tumor-free survival rates were about 80 percent in animals receiving the combination of GVAX vaccine and transplantation, 40 percent in animals receiving vaccination alone, and zero percent in animals receiving neither treatment.
¿ Ciblex Corp., of San Diego, said its scientists have demonstrated that oral administration of Ciblex's small-molecule compound CBX10913 blocks the release of interleukin-1Beta (IL-1Beta), a protein associated with inflammation, into the bloodstream of mice. The company believes that CBX10913 will treat inflammation by preventing the release of IL-1Beta.
¿ Genomic Solutions Inc., of Ann Arbor, Mich., said it will develop a new Center for Proteomics to be located at its headquarters. The new center will support proteomics research and development, as well as contract research and technical services for Genomic Solutions' proteomics customers. The company's Chelmsford, Mass., proteomics facility will be relocated to Ann Arbor, and Genomic Solutions will take a one-time restructuring charge of about $600,000 during the second quarter.
¿ GenStar Therapeutics, of San Diego, said it acquired technologies for the treatment and prevention of AIDS and for lentiviral gene therapy. The technologies were invented by AIDS researcher and lentiviral gene therapy expert Flossie Wong-Staal and her colleagues. They were developed at the University of California and exclusively licensed to Allegro Inc., which GenStar acquired for 300,000 shares of its stock. The AIDS product is based upon vaccination with genetically modified HIV. Preclinical testing should be completed this year.
¿ Genzyme General, of Cambridge, Mass., and GelTex Pharmaceuticals Inc., of Waltham, Mass., said a new study shows dramatic coronary artery calcification in young adult dialysis patients providing evidence of the need for changes in current management of phosphorus and calcium in treatment of end-stage renal disease. It highlights the importance of Renagel, which allows for the control of phosphorus levels without the use of calcium, Genzyme said. The study, published in the May 18 issue of the New England Journal of Medicine, found that nearly 90 percent of adults in their 20s undergoing dialysis had signs of coronary artery calcification. Patients with the signs had nearly twice the daily intake of calcium through phosphate-binding agents, compared to patients who showed no signs of calcification.
¿ Hyseq Inc., of Sunnyvale, Calif., said it has extended its exclusive gene discovery collaboration for two years with Chiron Corp., of Emeryville, Calif. The collaboration to develop solid tumor cancer therapeutics, diagnostic molecules and vaccines was started in 1997 and was worth $19.5 million to Hyseq. The new two-year term begins May 30. (See BioWorld Today, June 23, 1997, p. 1.)
¿ ICN Pharmaceuticals, of Costa Mesa, Calif., said its licensing partner, Schering-Plough Corp., of Madison, N.J., commenced sales in France of its Rebetol (ribavirin) capsules. Rebetol is for use in combination with Schering-Plough's interferon alfa-2b injection to treat chronically infected hepatitis C patients.
¿ Inhale Therapeutic Systems Inc., of San Carlos, Calif., said Phase I studies demonstrated the ability of the company's PulmoSphere particle processing technology to double the quantity of drug delivered to the deep lung compared to conventional micronized particles using a standard metered dose inhaler. Results of the nine-person study showed that mean lung deposition for the asthma drug albuterol sulfate, when formulated into PulmoSphere particles and delivered through a metered dose inhaler, was 29.8 percent vs. 15 percent for conventional micronized albuterol particles.
¿ InSite Vision Inc., of Alameda, Calif., said Global Damon Pharm and Kukje Pharma Ind. Co. Ltd. launched AquaSite in Korea. AquaSite is a dry eye treatment and the first product that used InSite's DuraSite technology.
¿ Qiagen NV, of Venlo, the Netherlands, said its board of supervisory directors and its managing board approved a 4-for-1 split of its common stock, subject to approval by shareholders on June 16. The company's chief financial officer, Peer Schatz, said the stock split follows the company's strategy of increasing the liquidity of Qiagen's shares.
¿ SkyePharma plc, of London, said it signed a second development agreement with Pfizer Inc., of New York, using its DepoFoam sustained-release injection technology to formulate a Pfizer compound. SkyePharma signed a feasibility agreement with Pfizer in March to use its Geomatrix delivery system. SkyePharma also said it entered into an agreement with Merck KgaA, of Darmstadt, Germany, to jointly develop an innovative formulation of a Merck compound, based on the Geomatrix technology. Merck will pay all development costs, and SkyePharma will receive royalties on sales.
¿ The Biotechnology Industry Organization, of Washington, and DoubleTwist Inc., of Oakland, Calif., signed a letter of intent to collaborate on building a comprehensive, independent Internet portal aimed at providing access to research and drug development tools and databases, e-commerce providers and jobs. Financial details are under discussion.
¿ Viron Therapeutics Inc., of Chicago, said SERP-1, a viral protein, demonstrated in animal studies the potential to work in synergy with immunosuppressive drugs to reduce kidney rejection. SERP-1 is Viron's lead product for transplant rejection and rheumatoid arthritis.