Acambis plc, of Cambridge, UK, was awarded two grants under the U.S. Department of Defenses Dual Use Science and Technology program. The grants, totaling $1.3 million, will support Acambis programs to develop vaccines to prevent diarrhea caused by enterotoxigenic E. coli (ETEC) and Campylobacter. Results of two Phase I trials of ETEC demonstrated the first candidate strain was well tolerated and immunogenic. Acambis has begun preclinical research toward the development of an oral vaccine for Campylobacter.
AEterna Laboratories Inc., of Quebec City, Quebec, said results from a Phase I/II study in 48 patients suffering from metastatic refractory prostate cancer confirm Neovastats safety profile and dose-related activity. Results showed no dose-limiting toxicity and patient compliance while improved conditions of disease stabilization were noted in patients as indicated by prostate specific antigen levels. The results were presented at the annual meeting of the Canadian Urological Association in Toronto. Neovastat is an antiangiogenic product.
Biophage Inc., of Montreal, Quebec, completed a C$850,000 (US$560,483) private placement representing about 1.4 million units priced at C60 cents per unit, with each consisting of one Class A share and one warrant to buy an additional Class A share at a price of C75 cents until Feb. 16, 2002. The financing was part of a letter of intent signed on April 10 between the controlling shareholders of the company and Almont Capital Corp.
Biospecifics Technologies Corp., of Lynbrook, N.Y., completed the construction and commencement of first-stage production runs at its new biopharmaceutical manufacturing facility. The facility was designed to manufacture Collagenase ABC, the active ingredient in the prescription drug Collagenase Santyl Ointment, marketed by Smith & Nephew Inc.
Canadian Medical Laboratories Ltd., of Mississauga, Ontario, said its wholly owned subsidiary, Cipher Pharmaceuticals, filed its first investigational new drug application with the FDA and the Canadian Therapeutics Product Directorate, for a formulation of fenofibrate. Cipher, formed in November of last year, licensed the drug formulation, designed to lower serum lipid levels in the blood, from Puerto Rico-based Galephar Pharmaceutical Research. Cipher has licensed two other products from Galephar, and said it expects to file similar INDs to begin their clinical programs in the near future.
Celgene Corp., of Warren, N.J., said preclinical studies of its JNK (c-Jun N-terminal kinase) inhibitor, SP600125, in inflammatory cells associated with rheumatoid arthritis, indicate that JNK activation is a primary mediator of joint destruction in arthritis. A research paper published in the July 1 edition of The Journal of Clinical Investigation (vol. 108, No. 1) detailed the results and indicated that SP600125 decreased JNK functional activity in animal models of rheumatoid arthritis.
Charles River Laboratories International Inc., of Wilmington, Mass., filed a registration statement with the SEC for a proposed underwritten offering of 8 million shares of its common stock, plus an additional 1.2 million shares to cover overallotments. Charles River will issue 2 million new shares and selling shareholders will sell the remaining 6 million shares and the overallotment shares. The company plans to use the proceeds to repay a portion of debt, to retire obligations incurred in connection with recent acquisitions and for general corporate purposes. Credit Suisse First Boston, of New York, and Lehman Brothers Inc., of New York, will act as lead managing underwriters for the offering. SG Cowen Securities Corp., of New York, and U.S. Bancorp Piper Jaffray Inc., of Minneapolis, will act as co-managing underwriters.
Endovasc Ltd., of Montgomery, Texas, presented data on long-term drug release from coronary stents coated with its Prostaglandin E-1 (PGE-1) conjugate at the Interventional Cardiovascular Therapeutics II meeting in Athens, Greece, earlier this month. The company said the data showed the drug was still eluting therapeutic levels of PGE-1 out to 75 days.
Entropin Inc., of Indio, Calif., announced the addition of a fourth clinical study site for its upcoming Phase II/III study with Esterom, a therapeutic for the treatment of painful soft-tissue injuries resulting in impaired function. Enrollment of the 150 patients is expected to begin in the third quarter of this year, and should take six months, the company said.
Epimmune Inc., of San Diego, granted a non-exclusive license to its PADRE technology for Pharmexa A/S, of Copenhagen, Denmark. Pharmexa will use the technology with its AutoVac therapeutic vaccine technology for controlling diseases associated with self-antigens. PADRE is a family of molecules that enhance immune system response against an administered immunogen. The license covers Pharmexas use of PADRE toward five target antigens, with financial terms including unspecified up-front fees, product sales royalties and milestone payments.
Fujisawa Pharmaceutical Co., of Japan, made an equity investment in Quark Biotech Inc., of Cleveland, as part of QBIs Series F financing. Funds from the investment will help finance the continuing development and preclinical and clinical studies of the drug candidates generated by QBIs applied genomics technology. Financial terms were not disclosed. Gliatech Inc., of Cleveland, received an additional $2.5 million under its agreement with Paul Capital Royalty Acquisition Fund LP. Gliatech received an initial $5 million from Paul Capital in April. The agreement calls for Gliatech to receive another $7.5 million upon satisfaction of certain conditions, including the U.S. relaunch of ADCON-L, its resorbable carbohydrate polymer product designed to inhibit post-surgical scarring and adhesions. Up to $15 million in additional funding is possible thereafter, Gliatech said. GPC Biotech, of Martinsried, Germany, said it achieved a milestone by delivering seven targets in its anti-microbial alliance to Byk Gulden, the pharmaceutical group of Altana AG. A selection of those validated targets will be moved into high-throughput screening by Byk to identify compounds for the treatment of Helicobacter pylori infections. The milestone achievement triggers undisclosed payments to GPC Biotech. MitoKor, of San Diego, said it completed the acquisition of Apollo BioPharmaceutics Inc., of Cambridge, Mass. Apollo will become a wholly owned subsidiary of MitoKor, with all outstanding shares converted into shares of MitoKor preferred stock. (See BioWorld Today, May 10, 2001.) Immunomedics Inc., of Morris Plains, N.J., said three presentations were given on bispecific antibodies for cancer radioimmunotherapy at the 48th annual meeting of the Society of Nuclear Medicine in Toronto. Interim results of a Phase I/II clinical trial in patients with diverse cancers producing carcinoembryonic antigen (CEA) were studied. The bispecific antibody received by patients was composed of half of an anti-CEA antibody linked to half of another antibody targeting a carrier with a therapeutic isotope attached to it. The clinicians later injected the carrier molecule and isotope, which then attached to the other antibody arm at the tumor. No patients showed toxicity after the therapeutic isotope was given, but much higher tumor doses, compared to directly labeled antibodies, were calculated. Myriad Genetics Inc., of Salt Lake City, said it has formed an exclusive collaboration with Bioscientia Ltd., of Ingelheim, Germany, to provide Myriads family of BRACAnalysis predictive medicine tests in Austria, Germany and Switzerland. Biosientia is one of Europes largest reference laboratories, serving hospitals, clinics, pharmaceutical companies and physicians. Under the agreement, Myriad will transfer technical know-how for site-specific mutation detection to Bioscientia. NicOx SA, of Sophia Antipolis, France, reported positive Phase I results for the first human administration of NCX 701, its nitric oxide-releasing derivative of paracetamol (acetaminophen), in development to treat pain and fever. The randomized, double-blind, placebo-controlled study evaluated five doses of an oral formulation of the drug, which was found to be well absorbed and showed tolerability at all doses tested. Nortran Pharmaceuticals Inc., of Vancouver, British Columbia, said it changed its name to Cardiome Pharma Corp., following a resolution passed by the shareholders at its recent annual general meeting. The name change reflects its strategy to focus on discovering and developing drugs to treat heart disease. Novuspharma SpA, of Monza, Italy, said it was granted investigational new drug status by the FDA for BBR 2778, its lead compound for non-Hodgkins lymphoma (NHL). Novuspharma has ongoing Phase II trials in which BBR 2778 is being given to patients with aggressive NHL as a single agent. The company plans to present final results from a Phase II monotherapy study at a scientific meeting later this year. Pilot Therapeutics Inc., of Winston-Salem, N.C., and Quintiles Transnational Corp., of Research Triangle Park, N.C., will work to commercialize Pilots lead product, PLT 3154, the first clinically validated natural therapy for people with asthma, the companies said. Under the alliance, Quintiles commercialization unit, Innovex, would be able to become the exclusive sales service provider for Pilots natural therapy for asthma. Quintiles corporate venture group, PharmaBio Development, will provide Pilot a milestone-based convertible line of credit to support development and premarketing needs. Procyon BioPharma Inc., of Montreal, completed a private placement of C$1 million (US$659,269) with NATCAN and SIPAR subscribing for C$500,000 each. The price per share was C$1.02, based on a 10-day average trading price preceding the close of the transaction. Proceeds will be used to fund Procyons research and development programs. Questcor Pharmaceuticals Inc., of Union City, Calif., signed a letter of understanding with Fabre Kramer Pharmaceuticals Inc., of Houston, to jointly pursue the worldwide development and commercialization of Hypnostat (intranasal triazolam) for insomnia and Panistat (intranasal alprazolam) for panic disorders. The companies anticipate forming a joint venture, with Fabre Kramer providing funding. Financial terms were not disclosed. Rosetta Inpharmatics Inc., of Kirkland, Wash., and Agilent Technologies Inc., of Palo Alto, Calif., announced that Monsanto Co., of St. Louis, licensed the Rosetta Resolver Gene Expression Data Analysis System, a bioinformatics system for gene expression research developed by Rosetta and distributed by Agilent. Financial terms were not disclosed. Sangamo BioSciences Inc., of Richmond, Calif., and Zycos Inc., of Lexington, Mass., announced a collaboration to assess the utility of Zycos gene transfer technology for the delivery of Sangamos zinc finger DNA-binding protein transcription factor (ZFP TF) genes in vivo. Sangamo will evaluate the effectiveness of Zycos gene expression system and biopolymer delivery system technologies for delivering its ZFP TF in preclinical model systems. Zycos Biotope vectors and Gencap microparticles for DNA delivery will be used to deliver a Sangamo ZFP TF. Financial terms were not disclosed. Select Therapeutics Inc., of Woburn, Mass., and its joint venture partner, Cytomatrix LLC, also of Woburn, announced the award of an additional $350,000 in contract funding from the U.S. Department of Defense to continue to advance a unique cell-based system for identifying and developing effective vaccines. The extension brings the total DOD funding on this program to $1.1 million since 1998, and will go directly into the companies 50-50 joint venture, Cell Science Therapeutics Inc. Theratechnologies, of Saint-Laurent, Quebec, began enrollment of insomnia patients for its second Phase II clinical trial for its ThGRF peptide. Ninety patients will take part in the parallel-design, double-blind, placebo-controlled trial in Canada and Europe, designed to demonstrate the efficacy of ThGRF on sleep and daytime performance and confirm its safety profile. Viragen Inc., of Plantation, Fla., and Viragen (Europe) Ltd. said they have received the first cancer vaccine progress report that detailed encouraging preliminary results in a project designed to develop a cancer vaccine therapy, called the Cancer Vaccine Project. The project is taking place at the Cancer Research Campaign Department of Clinical Oncology at the University of Nottingham, England. VistaGen Inc., of Burlingame, Calif., said the National Institutes of Health has awarded it a $219,000 Phase I Small Business Innovation Research grant for further development of an in vitro stem cell assay for anticancer drug toxicology assessment. The grant is the second to the company by the NIH. Telik Inc., of South San Francisco, presented data from its insulin receptor activator program at the 61st annual meeting of the American Diabetes Association in Philadelphia. The studies focused on TLK19781, one of Teliks orally active insulin receptor activators. The insulin receptor activators have been shown to lower blood glucose levels in diabetic rats following oral administration and stimulate glucose transport in human muscle cells obtained from insulin-resistant diabetes patients, the company said. Vernalis Group plc, of London, entered an agreement with Alcon Laboratories Inc., of Fort Worth, Texas, to explore approaches to the treatment of glaucoma. The companies will assess molecules from the Vernalis research portfolio that are thought to work selectively on receptors that are believed to control pressure within the eye. The companies anticipate entering into a broader research and development agreement for compounds that show positive results in this initial screening process. Financial terms were not disclosed. Vion Pharmaceuticals Inc., of New Haven, Conn., said its Form S-3 shelf registration statement filed with the Securities and Exchange Commission on April 3 was declared effective as of Tuesday. The registration statement allows Vion to sell up to an aggregate of 4.7 million shares of common stock, but the company said it had no immediate plans to offer any securities. Vion is focused on development of therapeutics and technology for cancer treatment.