¿ Anika Therapeutics Inc., of Woburn, Mass., received premarket approval from the FDA for Shellgel, a hyaluronic acid-based viscoelastic product designed to protect eye tissue and maintain eye shape during ophthalmic surgery. Cytosol Ophthalmics Inc., of Lenoir, N.C., will distribute the product.
¿ Arakis Ltd., of Cambridge, UK, and SkyePharma plc, of London, entered an agreement to jointly develop a novel tissue-remodeling agent for treating chronic obstructive pulmonary disease. Arakis will contribute initial intellectual property for AD 313, one of its performance-enhanced medicines, and SkyePharma will contribute its inhalation formulation and device technology. The companies will jointly fund AD 313, manage product development and equally share any revenue generated.
¿ Arius Research Inc., of Toronto, said it contracted Goodwin Biotechnology Inc., of Plantation, Fla., to manufacture supplies of Arius¿ antibodies, AR460-23 and AR5LAC-20, for upcoming cancer studies in humans. Goodwin is a manufacturer of monoclonal antibodies and recombinant proteins for preclinical and Phase I/II trials.
¿ Cantab Pharmaceuticals plc, of Cambridge, UK, reported that trading in its American depository shares on Nasdaq will be suspended, effective Thursday. Cantab¿s shares on the London Stock Exchange were delisted on May 9, after the company was acquired by the Xenova Group plc, of Slough, UK, for #124 million (US$179 million). (See BioWorld Today, Feb. 21, 2001.)
¿ Cerus Corp., of Concord, Calif., and Baxter Healthcare Corp., of Deerfield, Ill., reported results from the second cycle of platelet transfusions in their European Phase III trial of the Intercept Platelet System. The second-cycle study involved 10 of 52 patients who received an initial course of Intercept platelets as part of the trial and received another cycle of the pathogen-inactivated platelet transfusions during a subsequent period of thrombocytopenia, a condition characterized by a persistent reduction in platelet counts. They said the safety and efficacy of the second cycle of Intercept platelets was comparable to the first course, with comparable increases in platelet counts following transfusion.
¿ Consensus Pharmaceuticals Inc., of Medford, Mass., was awarded a $1.05 million accelerated Phase I/II Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases. The grant will advance the company¿s drug discovery program for CXCR4 receptor antagonists to prevent HIV from entering T lymphocytes. This is the third SBIR grant for Consensus and is complementary to an existant Phase II SBIR grant of $960,000 for the development of CCR5 receptor antagonists.
¿ Cubist Pharmaceuticals Inc., of Cambridge, Mass., completed enrollment in Study 9801, the second of its Phase III trials examining the efficacy and safety of Cidecin for the treatment of complicated skin and soft-tissue infection. The company said Cidecin is the first in a new class of antibiotics and has demonstrated rapid bactericidal activity in vitro against a wide range of Gram-positive bacteria, including strains resistant to current therapies. The company also completed enrollment in its Phase II/III feasibility study, evaluating the safety and efficacy of Cidecin in the treatment of complicated urinary tract infections caused by Gram-positive pathogens.
¿ Demegen Inc., of Pittsburgh, completed the third and final stage of its acquisition of the majority of the assets of Periodontix Inc., of Watertown, Mass. In February, Demegen announced a deal to license Periodontix technology, with a six-month option to purchase the rest of the company¿s assets. After the initial payment to license the technology, Demegen made payments for Periodontix in stages. Specific terms were not disclosed. Demegen develops novel antimicrobial peptides and proteins for the treatment of infectious disease and oncology. Demegen expects soon to begin a Phase I/II study for oral candidiasis, an AIDS-defining, opportunistic illness. (See BioWorld Today, Feb.12, 2001.)
¿ Endocyte Inc., of West Lafayette, Ind., secured $7.6 million in equity investments from Sanderling Venture Partners, of Menlo Park, Calif.; Cincinnati Financial Corp., of Cincinnati; and American Bailey Ventures, of Stamford, Conn. Endocyte will combine this initial capital investment with $2 million from Indiana¿s 21st Century Research and Technology Fund to continue clinical development of its oncology diagnostic and therapeutic products, purchase additional research equipment, and increase research and development staff.
¿ Genentech Inc., of South San Francisco, said its Foundation for Biomedical Sciences awarded 16 grants totaling more than $766,000 to organizations in the San Francisco Bay area. This amount is a 58 percent increase from last year¿s total. Genentech funds the foundation by providing payments and royalties from license agreements under the Riggs-Itakura family of patents.
¿ Genome Therapeutics Corp., of Waltham, Mass., extended its genomics-based research collaboration with Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home Products Corp., of Madison, N.J., for the prevention and treatment of osteoporosis. The alliance, formed in 1999, will be extended at least through December 2002, according to Genome Therapeutics. The company recently received milestone payments for the completion of a major advance as part of this research. If the program continues for its full term, total payments to Genome Therapeutics could exceed $118 million, excluding royalties. (See BioWorld Today, Dec. 23, 1999.)
¿ ImClone Systems Inc., of New York, said it achieved a manufacturing-related milestone under its 1998 agreement with Merck KGaA, of Darmstadt, Germany, for the rights to develop and market IMC-C225 outside North America. The milestone, which triggers a $2 million payment to ImClone, relates to the confirmation by Merck that European regulatory authorities approved the use of IMC-C225 clinical material, manufactured by ImClone. The use of IMC-C225 clinical material was authorized as part of the EU¿s approval of Merck¿s regulatory filing to initiate the European arm of a joint ImClone/Merck Phase III clinical trial of IMC-C225 and radiation in patients with head and neck cancer. (See BioWorld Today, Dec. 16, 1998.)
¿ MedImmune Inc., of Gaithersburg, Md., began dosing colorectal cancer patients in a Phase I/II trial of its product, Vitaxin, an antibody that has the potential to inhibit growth of new blood vessels by binding to a specific integrin expressed on a variety of cells that play a role in inflammatory diseases, including rheumatoid arthritis, restenosis and cancer, the company said. The study has two parts: Phase I is an open-label, single-center, dose-escalation trial that will enroll 16 patients, evaluate safety and determine a Phase II dose. Phase II also is designed as open label, but will involve 40 patients with advanced colorectal cancer and will evaluate Vitaxin¿s antitumor activity.
¿ Micrologix Biotech Inc., of Vancouver, British Columbia, suspended its plans for a Phase II efficacy study of MBI 853NL for preventing hospital-acquired Staphylococcus aureus, following results of its Phase Ib trial. Though results showed that MBI 853NL was safe and well tolerated, further clinical studies would involve greater risk, time and costs than could be justified, the company said. Micrologix said it would focus its attention on other products in its pipeline, including MBI 594AN for the treatment of acne, currently in a Phase II trial, and MBI 226 for the treatment of catheter-related bloodstream infections, currently in a Phase III trial.
¿ Ortec International Inc., of New York, adopted the name OrCel for its composite cultured skin product, which currently is being evaluated for the treatment of chronic wounds such as venous leg ulcers and diabetic foot ulcers. The FDA is reviewing Ortec¿s premarket approval application for OrCel. The company recently received FDA approval under a humanitarian device exemption to market its product for use in hand reconstruction and for donor sites created in that procedure.
¿ Sepracor Inc., of Marlborough, Mass., adopted the name Estorra for its drug candidate esopiclone, a non-benzodiazepine compound, for the treatment of insomnia. The company currently is completing Phase III clinical studies for Estorra. Sepracor reports that all study endpoints were clinically relevant and statistically significant compared to placebo, and the drug was well tolerated. The company is preparing a new drug application for the FDA.
¿ Vion Pharmaceuticals Inc., of New Haven, Conn., initiated the second Phase I combination trial of its investigational anticancer agent, Triapine. The study is designed to determine the safety and maximum dose of cisplatin when administered with Triapine to patients with advanced cancer. The study is open at the Arizona Clinical Research Center in Tucson. Triapine is an inhibitor of the enzyme ribonucleotide reductase.
¿ Visible Genetics Inc., of Toronto, entered into an agreement with Abbot Laboratories, of Abbot Park, Ill., under which VGI will assist Abbot by providing HIV resistance testing in two clinical studies involving Abbot¿s protease inhibitor, Kaletra. VGI will use its Trugene HIV-1 genotyping system to perform genotype analysis, and will include the data from the study in its HIV drug resistance mutation database.