¿ AltaRex Corp., of Waltham, Mass., said a laboratory study analyzing serum samples from patients treated with BrevaRex MAb and reported in the Journal Blood (Blood 2000, 96:3147) supports a multiple myeloma development strategy. It plans to initiate a BrevaRex MAb Phase I/II trial in the first half of 2001. In a previous study, AltaRex demonstrated that BrevaRex MAb can elicit B- and T-cell immune responses to the MUC1 tumor-associated antigen.
¿ Aventis Behring LLC, of King of Prussia, Pa., said the FDA granted fast-track review status for the development of an intravenous treatment for alpha-1 antitrypsin deficiency-related emphysema. The investigational drug is Alpha 1 Proteinase Inhibitor IV (human), being studied in Phase III trials.
¿ AVI BioPharma Inc., of Portland, Ore., said one of its scientists was awarded a $225,000 grant to pursue development of therapeutics to fight prostate cancer using AVI's NeuGene antisense drug platform. The grant was awarded by the Department of Defense Prostate Cancer Research Program and will help fund its ongoing cancer research collaborations.
¿ Bionova Holding Corp., of Oakland, Calif., as part of its new technology initiative, is developing commercial traits for crop protection and improved nutrition based on analysis of altered expression in Arabidopsis thaliana. It uses transcript profiling tools to transform genes into useable traits for the food and fiber production industries.
¿ Cambridge NeuroScience Inc., of Norwood, Mass., completed its merger with CeNeS Pharmaceuticals. The merger was announced on May 23. (See BioWorld Today, May 24, 2000.)
¿ Cellomics Inc., of Pittsburgh, postponed its initial public offering, planning to re-evaluate market conditions for its proposed IPO during the first quarter of 2001. It filed in March, seeking $100 million. (See BioWorld Today, March 8, 2000.)
¿ Curis Inc., of Cambridge, Mass., closed its private placement, announced Nov. 16, raising $46.8 million by selling 5.2 million shares of stock. Prudential Vector Healthcare Group, of New York, acted as placement agent. Curis now has about 31.3 million shares outstanding. The company plans to use the proceeds to fund its ongoing research and development and other corporate purposes. (See BioWorld Today, Nov. 17, 2000.)
¿ Demegen Inc., of Pittsburgh, said reports confirm its antimicrobial peptide vaginal microbicide is effective in killing Chlamydia. The new research shows the microbicidal activity in a gel formulation is maintained at varying pH levels and in the presence of human blood. The results of the in vitro studies have been submitted for publication in a peer-reviewed journal.
¿ DUSA Pharmaceuticals Inc., of Wilmington, Mass., said it received $15 million from Schering AG, of Berlin, in milestone and other payments based on their November 1999 agreement. The payment consists of a $7 million milestone and $8 million as an unrestricted research grant for use by DUSA at its discretion. These are the final payments related to DUSA's initial products, the Levulan Kerastick 20 percent topical solution, and the BLU-U and light device, for the treatment of non-hyperkeratotic actinic keratoses of the face and scalp.
¿ Epoch Biosciences Inc., of Redmond, Wash., formerly Epoch Pharmaceuticals Inc., began trading under its new name on Nasdaq, with the ticker symbol EBIO.
¿ Gene Logic Inc., of Gaithersburg, Md., established collaborations with N.V. Organon, the human health-care business of Akzo Nobel, of the Netherlands, and Boehringer Ingelheim International GmbH, of Ingelheim, Germany, which both subscribed to multiple segments of Gene Logic's GeneExpress database to use in their drug discovery and development programs. Organon and Gene Logic also entered a separate research collaboration to develop a custom gene expression database for generating and evaluating gene expression information. Also, Biogen Inc., of Cambridge, Mass., will receive a proprietary gene expression database from Gene Logic to be used for Biogen's genomics research initiatives. Financial terms for all deals were not disclosed.
¿ Genta Inc., of Berkeley Heights, N.J., signed an exclusive worldwide licensing agreement with the U.S. National Institutes of Health, of Bethesda, Md., for a novel type of cancer therapy known as decoy aptamers. A separate cooperative research and development agreement will be executed to provide funding of this work at the National Cancer Institute. The technology involves using the use of short sequences of oligonucleotides that can bind transcription factors. Decoy aptamers attach themselves to transcription factors, preventing their binding to normal DNA and preventing production of proteins that may be critically involved in the cause or progression of cancer.
¿ Gilead Sciences Inc., of Foster City, Calif., initiated a Phase II trial of NX 211 in patients with recurrent small-cell lung cancer. NX 211 is a liposomal formulation of a novel topoisomerase I inhibitor being developed for the potential treatment of various solid tumors. In November, Gilead initiated Phase II clinical trials of NX 211 with two separate studies in ovarian cancer patients.
¿ RegeneRx Biopharmaceuticals Inc., of Bethesda, Md., changed its name from Alpha 1 Biomedicals Inc. to better reflect its primary business focus - developing products for repair and healing of chronic wounds and injured tissue.
¿ Hemosol Inc., of Toronto, said an investigational new drug application has been filed for a Phase I/II study of Hemolink in patients with non-small-cell lung cancer who are experiencing chemotherapy-associated anemia. The trial will evaluate safety and tolerability as well as investigate the impact of higher hemoglobin values on patient quality of life and the effect of red blood cell production stimulated by erythropoietin. The trial is expected to be completed by the fourth quarter of 2001.
¿ ICN Pharmaceuticals Inc., of Costa Mesa, Calif., said Roche Holding AG, of Basel, Switzerland, agreed in principle to exchange its ownership stake in ICN for an 8.7 percent ownership stake in ICN's Ribapharm unit as part of a proposed tax-free spin-off by ICN of its interest in Ribapharm. Roche has an option to increase its ownership stake in Ribapharm to 17.5 percent by exchanging additional ICN shares. Roche has about 3.9 million shares of ICN Pharmaceuticals. Based on Thursday's opening price of $30.312 the stock swap would be worth about $120 million. Ribapharm is a wholly owned subsidiary of ICN and conducts ICN's U.S. research and development activities. It filed for an initial public offering in June. (See BioWorld Today, June 16, 2000.)
¿ Inhale Therapeutic Systems Inc., of San Carlos, Calif., made a $200 million offer to acquire Bradford Particle Design plc, of, Bradford, UK. The offer is $180 million in newly issued Inhale stock and $20 million in cash. Based on Inhale's average closing stock price from Nov. 3 to Dec. 20, the offer translates to about 3.7 million shares of Inhale stock plus the cash. The deal is expected to close in January. The company said Bradford's supercritical fluid technology has application as a better way to make powders for oral, inhalation, injectable and other pharmaceutical applications.
¿ Ischemia Technologies Inc., of Denver, completed is Series B financing. White Pines Ventures, of Ann Arbor, Mich.; Tenex Medical, of Silicon Valley, Calif.; and a European investor added $3.5 million to the $6.8 million received in its first closing in November, bringing the total for the round to $10.3 million. Ischemia develops products based on its patented biochemical marker, in which protein found in blood appears to be modified when exposed to ischemic tissue.
¿ Ixion Biotechnology Inc., of Alachua, Fla., said academic collaborators received a total of $207,000 in grants from the Oxalosis and Hyperoxaluria Foundation. The foundation is a not-for-profit medical foundation dedicated to providing information, service and support to medical professionals and patients and the families of those with oxalosis and hyperoxaluria.
¿ Novavax Inc., of Columbia, Md., completed its acquisition of privately held Fielding Pharmaceutical Co., of St. Louis. Novavax will operate Fielding as a wholly owned subsidiary. They will work on the research, development and marketing of proprietary women's health-care products.
¿ Oxagen Ltd., of Abingdon, UK, raised #30 million (US$44 million) in a private financing round. It was led by Schroder Ventures and Abingworth Management, and included investments from funds managed by 3i Bioscience Investment Trust plc, BankInvest Biomedical Venture, CSFB Private Equity, Invesco Europe Ltd., Oppenheimer Funds, Pacific Rim Ventures Co. Ltd., the Palladin Group LP and Quest for Growth. Additional funds were invested by 3i Group plc, funds managed by Advent Venture Partners and the University of Oxford Isis Colleges Funds. Oxagen uses large-scale family studies to understand the association of genes and genetic variations with disease.
¿ Phage Therapeutics International Inc., of Bothell, Wash., entered into a securities purchase agreement with seven purchasers totaling $5 million. In the first step, the purchasers received about 2.1 million units (consisting of one common share and one common stock purchase warrant) for $1.5 million. The purchasers later will invest another $1.5 million for about another 2.1 million units. From the exercise of the warrants, Phage expects to receive $1 million six months after the first step is completed and $1 million 12 months after the second step is completed. Among the uses of the proceeds will be for pharmaceutical development that will include manufacturing, developing and scale-up of the first bacteriophage pharmaceutical product.
¿ Procyon BioPharma Inc., of Montreal, said an investigational new drug application to complete Phase II studies has been filed with the Canadian Therapeutics Products Program branch of Health Canada for Fibrostat, a topical cream for the treatment of severe scars resulting from surgery or burns. The trial will involve eight centers across Canada, with an enrollment of a total of 128 patients.
¿ Protein Polymer Technologies Inc., of San Diego, signed a worldwide exclusive license agreement with Genencor International Inc., of Palo Alto, Calif., enabling Genencor to potentially develop a wide variety of new industrial products. Genencor can use Protein Polymer's proprietary protein polymer design and production technology, in combination with Genencor's extensive gene expression, protein design and large-scale manufacturing technology, to design and develop new products for industrial applications.
¿ Sepracor Inc., of Marlborough, Mass., said Schering-Plough Corp., of Madison, N.J., submitted a new drug application to the FDA for its nonsedating antihistamine desloratadine in a disintegrating tablet formulation as a treatment of seasonal allergic rhinitis and chronic idiopathic urticaria, or hives of unknown cause, in adults and children 12 years of age or older. Desloratadine, in a disintegrating tablet, is the fourth formulation of desloratadine to be submitted for marketing approval to the FDA.
¿ Texas Biotechnology Corp., of Houston, and SmithKline Beecham plc, of London, said they filed a supplemental new drug application for Argatroban with the FDA. If approved, it would expand the use of Argatroban to patients who have or who are at risk of developing heparin-induced thrombocytopenia and are undergoing percutaneous coronary intervention, most frequently coronary balloon angioplasty. Argatroban is a synthetic direct thrombin inhibitor that blocks the activity of thrombin.
¿ The North Carolina Genomics and Bioinformatics Consortium, of Research Triangle Park, N.C., a group of about 40 corporations, universities and nonprofit institutes in North Carolina, said it would strengthen the state's scientific, educational and business resources in genomics, proteomics and bioinformatics. Eleven public and private universities, 17 corporations and 11 nonprofit institutions throughout the state make up the consortium and more are coming on board.
¿ The Whitehead Institute, of Cambridge, Mass., and Corning Inc., of Corning, N.Y., invented a new microarray technique that can decipher the function of master switches in a cell by identifying the circuit, or the set of genes, they control across the entire genome. The researchers show that the technique can correctly identify the circuits controlled by two known master switches in yeast.
¿ VaxGen Inc., of Brisbane, Calif., said its chairman and CEO, Robert Nowinski, resigned from the board of directors and full-time employment effective last Friday. Nowinski said his decision to resign was accelerated by health reasons and he will continue as consultant to the company and as chairman emeritus. President Donald Francis will assume the duties of CEO.
¿ Visible Genetics Inc., of Toronto, said it has been granted French regulatory approval for its Trugene HIV-1 Genotyping Kit by the Agence Francaise De Securite Sanitaire Des Produits de Sante. It is able to launch the Trugene Kit in the rest of the European Union member states.