Alexion Pharmaceuticals Inc., of Cheshire, Conn., completed a two-month Phase I pilot safety trial in dermatomyositis patients with its humanized monoclonal antibody C5 complement inhibitor, 5G1.1. The drug appeared to be well tolerated and to improve skin rash. In this randomized, placebo-controlled, multicenter trial, 13 patients with persistent dermatomyositis undergoing concomitant treatment with moderate doses of methotrexate or steroids were evaluated in either a placebo or a single drug treatment arm. Drug treatment consisted of 5G1.1 at 8 mg/kg intravenous injection once per week for five weeks and then every two weeks for up to two months.
AtheroGenics Inc., of Atlanta, initiated a Phase IIb trial of its v-protectant drug, AGI-1067, for the treatment of restenosis and atherosclerosis. The trial, called the Canadian Antioxidant Restenosis Trial-2 (CART-2), will explore the drugs positive effect on reducing restenosis by extending the duration of dosing and will investigate the impact of AGI-1067 on the reversal of atherosclerosis. The study will enroll 500 patients in about 24 sites. Patients will receive 280-mg doses for 12 months.
Avigen Inc., of Alameda, Calif., received notice from the FDA that it can continue clinical testing of Coagulin-B, its gene therapy treatment for hemophilia B. The trial was suspended in October when a trace amount of DNA from the gene therapy was detected in the seminal fluid of the first patient to participate. Existing FDA protocols required the pause and subsequent testing confirmed the trace DNA cleared the patients body. In the trial, patients with hemophilia B receive Avigens adeno-associated virus vector containing the Factor IX gene, Coagulin-B, via infusion into the hepatic artery. (See BioWorld Today, Oct. 9, 2001.)
Bioject Medical Technologies Inc., of Portland, Ore., completed a private offering of 350,000 shares priced at $11 apiece, raising $3.85 million. Leerink, Swann & Co., of Boston, acted as placement agent for the financing as well as adviser. Bioject is a developer and manufacturer of needle-free drug delivery systems.
Cytovax Biotechnologies Inc., of Edmonton, Alberta, filed a clinical trial application with Health Canada to begin studies of its lead product, Cytovaxine, a peptide vaccine for the prevention of infections caused by Pseudomonas aeruginosa. Upon approval, Cytovax plans to begin Phase I trial enrollment in the first quarter. The trial will be conducted at a single Canadian site and will focus on the safety and immunogenicity of the vaccine.
Genome Therapeutics Corp., of Waltham, Mass., and Creighton University, of Omaha, Neb., researchers reported in the current issue of the American Journal of Human Genetics their identification of a specific gene mutation in the LRP5 gene that leads to increased bone mass. By studying members of a large extended family, researchers identified a single amino acid change in the LRP5 protein receptor responsible for above-average bone mineral density. The finding might be applicable in the treatment of osteoporosis. This finding also is the cornerstone in a multiyear alliance with Wyeth-Ayerst Laboratories Inc., of Radnor, Pa., for genomics-based osteoporosis drug discovery.
Genomic Solutions Inc., of Ann Arbor, Mich., completed its transaction to acquire Cartesian Technologies Inc., of Irvine, Calif. The acquisition extends Genomic Solutions capabilities into high-throughput screening and strengthens the companys position as a global provider of comprehensive DNA analysis and drug discovery solutions.
GlycoDesign Inc., of Toronto, and Leo Pharmaceutical Products Ltd., of Denmark, initiated a Phase I trial with their lead antithrombotic drug candidate, GH9001. The trial is being conducted in the United Kingdom and will evaluate dosing and safety for both intravenous and subcutaneous administration. The trial has four dosing groups with eight volunteers apiece. Leo is manufacturing the clinical supplies.
Guava Technologies Inc., of Burlingame, Calif., entered a five-year, $5.5 million distribution agreement with Bay Bioscience KK, of Kobe, Japan, to manage the distribution of the Guava Personal Cytometer in the Japanese market. Additionally, the company closed a $6 million Series D round of funding to facilitate the Japanese expansion.
Heska Corp., of Fort Collins, Colo., completed a private placement of about 7.8 million shares of common stock for aggregate proceeds of about $6 million. The shares were purchased by a select group of institutional investors, led by the state of Wisconsin Investment Board. Heska intends to use the proceeds for working capital and general corporate purposes.
ICN Pharmaceuticals Inc., of Costa Mesa, Calif., completed the exchange offer relating to its 8.75 percent senior notes, having a par value of $194.6 million. The notes have a maturity date of 2008. The full 100 percent of the notes were exchanged for 8.75 percent Series B senior notes. It said it expects to commence a tender process for the exchanged notes in 2002 as part of its planned reorganization process.
ISTA Pharmaceuticals Inc., of Irvine, Calif., and Otsuka Pharmaceutical Co. Ltd., part of the Otsuka Group, of Tokyo, entered into agreements for Vitrase for the treatment of severe vitreous hemorrhage and diabetic retinopathy. ISTA granted Otsuka exclusive rights for the development and commercialization of Vitrase in Japan, where Otsuka will be responsible for all clinical development, regulatory, sales and marketing activities. ISTA will be responsible for the manufacture of Vitrase for Otsuka. Otsuka made an initial license fee payment to ISTA and will make an additional payment to ISTA if and when Vitrase receives regulatory approval in Japan. Also, Otsuka made a $4 million equity investment in ISTA by purchasing 845,665 shares of ISTA common stock. Separately, ISTA said it would implement a strategic plan to transition from a development organization to a fully integrated, specialty pharmaceutical company focused primarily on ophthalmology.
Kourion Therapeutics, of Dusseldorf, Germany, said it entered a collaboration with Case Western Reserve University and its stem cell researcher, Arnold Caplan. Also, Caplan joined the scientific advisory board of Kourion. The parties aim to explore the differentiation potential of a type of stem cell obtained by Kourion. A possible application might be the repair and healing of complicated bone fractures, Kourion said.
Medivir AB, of Stockholm, Sweden, and Peptimmune Inc., of Cambridge, Mass., a business unit of Genzyme General, said that an orally active, small-molecule inhibitor of the protease enzyme Cathepsin S suppresses the development of arthritis in an animal disease model. This finding raises hope of a new treatment to manage rheumatoid arthritis. Oral dosing of the inhibitor in mice prevented arthritis development without any apparent signs of toxicity. Currently approved drugs are designed to treat symptoms rather than halting the autoimmune reaction that is the underlying cause of the disease.
Mindset BioPharmaceuticals Inc., of Jerusalem, will receive $15 million, in two tranches, invested by MPM Capital LP, of Boston, and Clal Biotechnology Industries Ltd., of Tel-Aviv, Israel. The companies co-led the round of financing and will receive a majority interest in Mindset for their support. Mindsets two lead therapeutic programs focus on the two major disease mechanisms of Alzheimers: oxidative damage and amyloid plaque formation.
MorphoSys AG, of Martinsried, Germany, signed a strategic collaboration with Schering AG, of Berlin, for the development of antibody therapeutics and in vivo diagnostics. Schering will purchase a 10 percent equity stake in MorphoSys and MorphoSys will receive committed license fees and research and development funding over the three-year collaboration. The companies intend to combine resources and pursue a minimum of five therapeutics and several in vivo diagnostics projects.
NeoTherapeutics Inc., of Irvine, Calif., said its genomics division, NeoGene, entered into an agreement with Pfizer Inc., of New York. This marks the second agreement between Pfizer and NeoGene this year. Under terms of the additional agreement, NeoTherapeutics will receive an initial payment and milestone payments similar to the previous agreement. The new deal relates to use of an orphan receptor identified by NeoGene. (See BioWorld Today, March 20, 2001.)
Peregrine Pharmaceuticals Inc., of Tustin, Calif., initiated human antibody generation against two additional targets with Xenerex Biosciences, a subsidiary of Avanir Pharmaceuticals Inc., of San Diego. Both of these antibodies are being developed to potentially be used as fully human monoclonal antibody therapies for the treatment of solid tumors. The initiation of antibody generation against the new targets will complete the transfer of three targets from Peregrine to Xenerex under the terms of an agreement signed in June.
PhotoCure ASA, of Oslo, Norway, signed an exclusive global licensing agreement with Galderma SA, a 50/50 joint venture of LOreal and Nestle, for Metvix PDT, its approved treatment for certain cancerous and precancerous dermatological conditions. The agreement gives Galderma the exclusive right to market both the Metvix cream and Photocures activating light sources outside the Nordic region. In addition to royalties, Photocure will receive EUR12 million (US$10.7 million) upon signing and an additional EUR18 million as milestone payments linked to market authorizations and launch in key markets.
Protein Design Labs Inc., of Fremont, Calif., granted a nonexclusive license under its antibody humanization patents to Celltech Group plc, of London, for humanized antibodies against tumor necrosis factor-alpha (TNF-a), believed to be an important factor in the inflammatory process in humans. The license was granted under the terms of an agreement announced by the companies in January 2000 covering certain intellectual property in the field of humanized antibodies, and triggers payment of an additional license fee to PDL.
SciClone Pharmaceuticals Inc., of San Mateo, Calif., initiated an oncology development program in Europe for Zadaxin, its immune system enhancer drug. The program is being sponsored by Sigma-Tau S.p.A. Phase II malignant melanoma trials are scheduled to begin in 2002. The companies collaboration was initially formed to develop and market Zadaxin in Europe for the treatment of hepatitis C.
Serono SA, of Geneva, Switzerland, signed a multiyear subscription to the genomic databases of Celera Genomics Group, of Rockville, Md. The mouse and human genome sequences in the database will support Seronos drug discovery program, Serono said. Financial terms were not disclosed.
Sicor Inc., of Irvine, Calif., entered into a licensing and development agreement with EPIC Therapeutics Inc., of Norwood, Mass. The initial project involves the development of a depot formulation (LeuProMaxx) of leuprolide acetate formulated to be clinically equivalent to Lupron Depot, a lutenizing hormone-releasing hormone agonist indicated for the treatment of prostate cancer, endometriosis and uterine fibroids. Sicor and EPIC intend to develop additional compounds over the contract term to further capitalize on EPICs technology. Terms of the agreement were not disclosed.
Stressgen Biotechnologies Corp., of Victoria, British Columbia, completed its offering of about 6.7 million shares at C$4.15 per share, grossing about C$27.8 million (US$17.6 million). Underwriters bought 675,000 shares to cover overallotments. The offering was made through a syndicate of underwriters co-led by Raymond James Ltd. and BMO Nesbitt Burns Inc. and included Yorkton Securities Inc. (See BioWorld Today, Dec. 5, 2001.)
Variagenics Inc., of Cambridge, Mass., entered a research and development collaboration with GeneMatrix Inc., of Korea. The companies will strive to develop molecular diagnostic products for predicting response to leading drugs in the treatment of colon and gastric cancer. They will collaborate on pharmacogenomic research and clinical development of targeted therapeutics. Financial details were not disclosed.