• Alexion Pharmaceuticals Inc., of Cheshire, Conn., reported that both the FDA and the European Agency for the Evaluation of Medicinal Products granted eculizumab orphan drug status for the treatment of PNH. Patients with PNH have a deficiency in certain protective proteins on the surface of their red blood cells, allowing their own complement system to attack and destroy those cells.

• Angiogenix Inc., of Burlingame, Calif., started a Phase II trial of Acclaim in chronic angina. Acclaim (organic nitrate combined with L-arginine) is an oral product shown to induce coronary vasodilation while overcoming drug tolerance. The Phase II trial will enroll 170 patients with documented coronary artery disease who suffer from chronic, stable, effort-induced angina. The endpoint is treadmill walking time determined from the beginning of the exercise test until the patient develops angina of moderate degree.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, reported its intention to implement a 2-for-1 stock split, subject to shareholder approval. The company will seek approval at a special meeting of shareholders on Jan. 20. Angiotech is focused on enhancing the performance of medical devices and biomaterials through the use of pharmacotherapeutics.

• Avigen Inc., of Alameda, Calif., exclusively licensed rights to the treatment of chronic pain using anti-inflammatory cytokines, including interleukin-10, from the University of Colorado. Avigen also expanded its existing sponsored research agreement with the University of Colorado at Boulder to further work in the treatment of chronic pain under way at the university's department of psychology and center for neuroscience.

• Benitec Ltd., of Queensland, Australia; Commonwealth Scientific and Industrial Research Organisation (CSIRO) in Canberra, Australia; and the Queensland Department of Primary Industries in Queensland, entered a strategic agreement that will accelerate Australia's lead in the global commercialization of DNA Directed RNA interference, a gene silencing technology. Called ddRNAi, the technology was invented in Australia and is designed to be used in bioresearch institutes, biotech and pharmaceutical companies worldwide. Benitec will focus on commercializing ddRNAi for human applications including research models used in functional proteomics. CSIRO will focus on nonhuman applications, including plants, animals and insects. Queensland DPI will continue its ddRNAi research and will have access to both Benitec and CSIRO's global commercialization pathways.

• Biomira Inc., of Edmonton, Alberta, and Merck KGaA, of Darmstadt, Germany, reported a final analysis of Phase III data at the San Antonio Breast Cancer Symposium related to their study of the Theratope vaccine in women with metastatic breast cancer. Early this summer, the partners said the study failed to meet two pre-determined statistical endpoints - time to disease progression and overall survival - though analysis of Theratope-treated patients in one pre-stratified subset of more than 300 women who received hormonal treatment following chemotherapy and appeared to show a favorable trend toward improvement in survival. The added analyses revealed a median time to disease progression of 8.3 months for patients treated with Theratope vs. 5.8 months for those on control (Cox p=0.220; Log Rank p=0.207). The median survival was 38.2 months in the Theratope arm vs. 30.7 months in the control arm (Cox p=0.077; Log Rank p=0.066). (See BioWorld Today, June 18, 2003.)

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., reported preclinical data at last week's Pharmaceutical Education Associates symposium on Inhalation Drug Delivery in Princeton, N.J., showing that its BioAir calcium phosphate nanoparticulate delivery system for inhalable insulin significantly increased the systemic residence time and duration of action of the insulin. More specifically, the amount of insulin that became available through the bloodstream was 1.8 times more than that of injected insulin.

• Cel-Sci Corp., of Vienna, Va., reported the publication of data from a Phase I/II trial in 54 advanced primary head and neck cancer patients. The data demonstrated that treatment with Cel-Sci's immunotherapy drug Multikine rendered the majority of cancer cells susceptible to radiation therapy. The increased sensitivity of the Multikine-treated tumors to radiation was derived from an increase in the number of proliferating cancer cells. Following treatment, the majority of the tumor cells were in a proliferative state. Control patients had lower expression of the same proliferation marker, Ki67, in the study (p<0.05). The data were published in the December 2003 issue of The Laryngoscope.

• Crucell NV, of Leiden, the Netherlands, signed a service agreement with Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., whereby Crucell will undertake the development of a cell line based on its PER.C6 technology for the production of a recombinant protein product candidate for Progenics. Crucell will receive payments on reaching milestones outlined in the program. Further financial details were not disclosed. Crucell's PER.C6 technology is designed to offer a safe and scalable cell line for the production of a range of biologics.

• Gen-Probe Inc., of San Diego, and Tosoh Corp., of Tokyo, cross-licensed intellectual property covering certain nucleic acid-testing technologies. The licenses, which are effective Jan. 1, cover products in clinical diagnostics and other related fields. Tosoh will receive nonexclusive rights to Gen-Probe's transcription-mediated amplification and ribosomal RNA technologies in exchange for two payments totaling $7 million in 2004. Additionally, Tosoh will pay Gen-Probe royalties on worldwide sales of products that employ the licensed Gen-Probe technologies.

• Immtech International Inc., of Vernon Hills, Ill., said its oral drug candidate, DB289, demonstrated antimalarial activity in a clinical trial conducted in Bangkok, Thailand. The results were presented at the annual meeting of the American Society of Tropical Medicine and Hygiene on Dec. 6 in Philadelphia. Of 32 treated patients, nine were infected with Plasmodium vivax and 23 patients with Plasmodium falciparum, the most deadly form of malaria found in humans. All the patients cleared the malaria parasite and malaria symptoms. Fifty percent of the patients cleared the parasite within 24 hours of the first dose. Of the 23 patients treated for P. falciparum, the cure rate was 91 percent as two of the patients had malaria in the 28-day after-treatment period, but it could be the result of re-infection, the company said.

• Kosan Biosciences Inc., of Hayward, Calif., started a Phase II trial within its partnership with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, to evaluate the efficacy of KOS-862 as a monotherapy for colorectal, non-small-cell lung and metastatic breast cancers. KOS-862 is one of Kosan's two lead oncology programs and is a polyketide that inhibits cancer cells by the same mechanism as paclitaxel. In preclinical models, it was shown to be effective against paclitaxel-resistant tumors.

• Microscience Ltd., of London, entered a Cooperative Research and Development Agreement with the Naval Medical Research Centre in Silver Springs, Md. The collaboration will evaluate preclinically what Microscience believes will be the first oral anthrax vaccine to enter human testing. Under the CRADA, Microscience will provide its spi-VEC delivery system, which has been engineered to deliver anthrax antigens, either as protein or DNA, via an oral route.

• Noven Pharmaceuticals Inc., of Miami, said the FDA issued recommendations regarding the company's proposed study design for MethyPatch, a development methylphenidate transdermal system for attention deficit hyperactivity disorder. The FDA also accepted for filing the abbreviated new drug application for Noven's developmental transdermal fentanyl system for chronic pain. The company said it is working with partner Shire Pharmaceuticals Group plc, of Andover, UK, to review and respond to the FDA's comments regarding study design.

• Proneuron Biotechnologies Inc., of Los Angeles, said that enrollment in its Phase II trial of ProCord now is open to patients at Craig Hospital in Denver. Proneuron focuses on the development of treatments for patients with spinal cord injuries and other acute and chronic disorders of the central nervous system. ProCord consists of autologous activated macrophage therapy for a randomized trial for patients with acute complete spinal cord injury within 14 days of injury.

• Quigley Corp., of Doylestown, Pa., said an independent in vitro study conducted by Retroscreen Virology Ltd. (an affiliate of the University of London) demonstrated that Quigley test compounds previously tested on the influenza virus showed "significant virucidal activity against the Urbani strain of the severe acute respiratory syndrome virus." The compound was demonstrated to be 100 percent effective in preventing influenza A in ferrets in an earlier study.

• Scynexis Europe Ltd., of Cambridge, UK, and GeneCare Research Institute Co. Ltd., of Kamakura, Japan, reported details of a new deal between the companies. Scynexis will provide a range of drug discovery, synthesis and purification services to support GeneCare Research Institute's ongoing work in the field of anti-inflammatory drugs. Using Scynexis' HEOS operating system, hit explosion work will be undertaken to develop compound libraries for subsequent screening by GeneCare Research Institute. HEOS also will be used for lead optimization to identify clinical candidates. Terms of the deal were not disclosed.

• Tripos Inc., of St. Louis, and Biovitrum AB, of Stockholm, Sweden, released favorable results from the companies' discovery research partnership. In less than three months, Tripos successfully designed and synthesized a lead series for one of Biovitrum's high-priority projects. The partners also entered a new collaborative software research program to develop improved tools for drug discovery. Biovitrum's acquisition of new LeadQuest compounds to augment its existing screening library coupled with Tripos' software programs (ChemSpace and SARNavigator) allowed the companies to identify and optimize two lead series for follow-up.