¿ Akkadix Corp., of La Jolla, Calif., said it used its proprietary software and database to identify novel protein function in the cholera pathogen, Vibrio cholerae, and in Xylella fastidiosa, the cause of citrus variegated chlorosis. Complete sequencing of those genomes was announced recently by two research teams.
¿ Alpha Therapeutic Corp., of Los Angeles, promoted Edward Colton to president and chief executive officer. Colton was recently chief operating officer and has been with the company for 19 years. He joined Alpha in 1981 as general counsel and director, corporate taxes, and previously was senior vice president, general counsel and chief financial officer.
¿ Altea Development Corp., of Atlanta, received a Phase I grant of $99,042 from the National Institute of Arthritis, Musculoskeletal and Skin Diseases division of the NIH to study Altea's MicroPor system for non-invasive delivery of parathyroid hormone. MicroPor creates microscopic pores in the outermost dead layer of skin cells, opening tiny pathways to underlying viable tissues.
¿ Alteon Inc., of Ramsey, N.J., agreed to raise $6.24 million through the private placement of 2.8 million shares of common stock at $2.20 per share to institutional investors, including funds managed by S.A.C. Capital Associates LLC, Narragansett Asset Management LLC, and SDS Capital Partners LLC. Alteon plans to use the proceeds to broaden the development of its lead A.G.E. crosslink breaker, ALT-711, currently in a Phase IIa clinical trial for cardiovascular compliance.
¿ Alza Corp., of Mountain View, Calif., exercised its option to acquire, for $100 million in cash, all the outstanding shares of Cresendo Pharmaceuticals Corp. Cresendo shareholders will receive about $20.27 per share. The closing date is Nov. 13. Cresendo was formed in 1997 to develop products, most likely by licensing them to Alza.
¿ AMBI Inc., of Purchase, N.Y., appointed Gail Montgomery president, CEO and a director. She most recently was vice president of the Nutrition 21 business at AMBI, which has moved from an infectious disease development firm to one focused on nutrition.
¿ Amylin Pharmaceuticals Inc., of San Diego, completed its first Phase I study of AC3056, an oral drug being evaluated for prevention of restenosis following angioplasty and other procedures to open clogged arteries. The company said data were encouraging enough to warrant continuation of the Phase I program.
¿ AVAX Technologies Inc., of Kansas City, Mo., said AVAX Australia Pty. Ltd., a 50 percent owned joint venture with Australian Vaccine Technologies, of Sydney, Australia, has obtained tumor cells from cancer patients in Australia and plans to begin vaccine treatment using AVAX's M-Vax cancer vaccine for Stage III melanoma metastatic to the lymph node. M-Vax is manufactured using a patient's own tumor cells, collected after surgical removal of the tumor.
¿ AxCell Biosciences Corp., of Princeton, N.J., and Molecular Staging Inc., of Guilford, Conn., initiated an investigation on potential synergies between their technologies to map protein pathways more rapidly and efficiently. By combining AxCell's domain-ligand interaction technology with MSI's protein arrays, the companies believe they may be able to increase the rate of protein interaction measurements by 10-fold more than AxCell's current rate of about 10,000 interactions per day.
¿ BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., completed a Phase I clinical trial on its proprietary calcium phosphate nonoparticles (CAP) as a vaccine adjuvant and delivery system. The company received clearance in August from the FDA to initiate the clinical trial based on an IND application filed in July. The trial showed there were no apparent differences in side effect profile between CAP and placebo.
¿ Coulter Pharmaceutical Inc., of South San Francisco, entered into a license and research agreement with Yissum, the technology transfer arm of Hebrew University, for rights to an approach to treating rheumatoid arthritis by targeting synovial cells responsible for infiltrating and inflaming joints. The company and university plan to develop monoclonal antibodies targeting the variant CD44 marker on these cells. Coulter has committed a two-year research grant, milestones and royalties from resulting products to the university.
¿ Discovery Partners International Inc., of San Diego, signed a multiyear agreement with Procter & Gamble Co., of Cincinnati, in which ChemRx Advanced Technologies, a division of Discovery, will provide Procter & Gamble with compounds over a three-year period, with the option of providing hit follow-up and lead optimization. Financial terms of the deal were not disclosed.
¿ Entropin Inc., of Indio, Calif., saw its stock (NASDAQ:ETOP) fall 49 percent Monday, to $4.937, after a preliminary analysis of its Phase IIIa study of Esterom, its topical treatment for treating impaired range of motion. Statistical significance was not achieved (p=0.14) on the primary endpoint - patient questionnaires assessing shoulder function. The company said it will use the information to help design a pivotal study, which is expected to start in the first quarter of 2001.
¿ Enzo Biochem Inc., of Farmingdale, N.Y., said data on the first individual treated in the Phase I clinical trial of HGTV-43, the company's gene medicine product, show that after 9.5 months, Enzo engineered cells have successfully engrafted in the patient's bone marrow and were spawning new differentiated CD4+ cells designed to fight the virus. Enzo is currently compiling and analyzing data from the remaining five patients in the trial.
¿ EPIcyte Pharmaceutical Inc., of San Diego, was awarded Phase I and Phase II small business innovation research grants from the National Institutes of Health for the development of antibodies for sexual health products. The grants are worth $2.3 million and will fund EPIcyte's product development and clinical trials for an anti-HIV topical microbicide to prevent the sexual transmission of HIV and an antiherpes lubricant to prevent the vaginal transmission of herpes simplex virus-2.
¿ GeneLogic Inc., of Gaithersburg, Md., said UCB Research, a division of UCB Pharma, of Brussels, Belgium, subscribed to a segment of its GeneExpress Suite of databases for use in discovery and development, and the companies expanded their partnership for developing a custom gene expression database focused on allergy. Terms of the deals were not disclosed.
¿ Genentech Inc., of South San Francisco, submitted to the FDA a supplemental biologics license application for Alteplase for restoring function to central venous access devices that have become blocked, thus preventing withdrawal or infusion of vital fluids. Efficacy was evaluated in two pivotal trials that assessed Alteplase in restoring flow in occluded catheters in patients with CVADs.
¿ GeneTrace Systems Inc., of Alameda, Calif., completed a milestone in its collaboration with Berlex Biosciences Inc., of Richmond, Calif., in which the companies studied GeneTrace's proprietary high-throughput multiplex expression assay for screening of chemical libraries against multiple known and unknown gene targets. The collaboration consisted of the multiplexed screening of a set of genes known to be involved in prostate cancer against compounds from the Berlex chemical library and the study demonstrated that multiplexed screening can be reproduced in high throughput.
¿ Genta Inc., of Berkeley Heights, N.J., raised $14.6 million through the private placement of common stock. Gruntal & Co. acted as lead adviser, and investors included S.G. Cowen, Kaufmann Fund and Narragansett Asset Management. Proceeds primarily will be used to fund Phase III trials of Genasense, which is being tested against advanced melanoma, to launch additional studies of the compound, and to fund premarketing activities. The money also is expected to help the company in its partnership talks.
¿ Genyzme Transgenics Corp., of Framingham, Mass., reacquired the rights from Sumitomo Metals Industries Ltd., of Tokyo, to Genyzme's technology in 18 Asian countries for the production of medicines in milk. The 10-year-old joint venture between the companies has been dissolved. Genzyme can now directly develop its technology and the associated products in all 18 Asian countries or enter into separate agreements on a country-by-country or product-by-product basis.
¿ Genzyme Surgical Products Inc., of Cambridge, Mass., initiated a clinical trial of a proprietary gene therapy designed to promote the growth of new blood vessels around blocked coronary arteries. The protocol for the trial was cleared earlier this year by the FDA, but Genzyme was waiting review of the protocol by the NIH Recombinant DNA Advisory Committee before initiating the trial. The Phase I study will evaluate the use of a novel gene therapy based on an engineered form of the gene known as HIF-1a, which has been shown in preclinical studies to turn on the expression of many proteins associated with blood vessel formation.
¿ IGEN International Inc., of Gaithersburg, Md., and Sumitomo Corp., of Tokyo, signed a five-year nonexclusive agreement under which Sumitomo subsidiary SC BioSciences Corp. will distribute IGEN's M-Series M8 biological detection system in Japan. SC BioSciences will purchase a minimum of $15.4 million of M8 instruments for distribution. The M8 system is designed for use in a wide variety of pharmaceutical research and development processes.
¿ ImmunoGen Inc., of Cambridge, Mass., and MorphoSys AG, of Martinsried, Germany, entered a collaboration to develop human antibodies to treat cancer. MorphoSys will receive a technology access payment as well as development-related milestones and royalties on resulting products. MorphoSys will apply its HuCAL-Fab technology to discover and optimize antibodies against an unspecified ImmunoGen cell surface target.
¿ Incyte Genomics Inc., of Palo Alto, Calif., and Sequenom Inc., of San Diego, will collaborate to create validated single nucleotide polymorphism (SNP) assays for use in genetic research. Under the terms of the agreement, Incyte will license SNPs to Sequenom for analysis and validation using Sequenom's MassARRAY technology, which is capable of analyzing hundreds of samples in a single reaction. Sequenom will screen the SNPs against its in-house reference human DNA bank.
¿ Invitrogen Corp., of San Diego, following the completion of its acquisition of Life Technologies Inc., intends to reorganize into two lines of business: a molecular biology division, focusing on gene cloning and expression, and a cell culture division, concentrating on opportunities in markets for cell culture media and serum production. Also, it said it will strengthen its global sales and distribution focusing on molecular biology products and services.
¿ Luminex Corp., of Austin, Texas, released details of a project that will enable the detection and treatment of diseases at earlier stages by elucidating certain biochemical changes detectable only in blood. Luminex, using its LabMap technology, will screen tens of thousands of blood samples to assess the role of approximately 300 components in disease and the results will be analyzed by using several bioinformatic software methods.
¿ NeoRx Corp., of Seattle, began a Phase III clinical trial of its skeletal targeted radiotherapy (STR) for the treatment of multiple myeloma. Patient enrollment has begun and approximately 20 cancer centers in the U.S. are expected to participate. STR delivers high-dose radiation directly to the tumor and bone with minimal exposure to other organs.
¿ Novo Nordisk Pharmaceuticals Inc., of Princeton, N.J., said the Norditropin cartridge, a premixed growth hormone for injection pen delivery, is now available in the U.S. The company said the new product offers compliance benefits.
¿ Ortec International Inc., of New York, received gross proceeds of $8.4 million through a private placement of 1.2 million shares of common stock to a select group of institutional investors led by Franklin Templeton Investments, of Rancho Cordova, Calif. Stephens Inc. served as a placement for the private placement and its affiliates participated in the financing. Ortec now has approximately 9.6 million shares outstanding.
¿ Packard BioScience Co., of Meriden, Conn., acquired GSLI Life Sciences, a division of GSI Lumonics Inc., including its bioinformatics software products. Packard paid $40 million and approximately 4.6 million shares of its common stock. The GSLI Life Sciences group will become a part of Packard BioChip Technologies LLC. (See BioWorld Today, Aug. 22, 2000, p. 1.)
¿ PowderJect Pharmaceuticals plc, of Oxford, England, completed its acquisition of Medeva's vaccines business from Celltech Group plc, of Slough, England. The business will be merged into PowderJect's wholly owned subsidiary, PowderJect Vaccines.
¿ Serono Inc., of Geneva, Switzerland, has been granted FDA marketing approval for Ovidrel for use in infertility treatment. Ovidrel is the first recombinant human chorionic gonadotropin to be approved in the world and Serono is planning to launch Ovidrel in the U.S. by the first quarter of 2001.
¿ V.I. Technologies Inc., of Watertown, Mass., received FDA clearance to begin a Phase II trial of PEN110, its Inactine product to inactivate pathogens in red blood cells.
¿ Zonagen Inc., of The Woodlands, Texas, started a mechanistic study of phentolamine mesylate induced brown fat proliferation in rats. The company had been notified by the FDA that a shorter mechanistic study was OK in lieu of the additional two-year rodent study formerly requested. Successful completion of the study will be required before the FDA will lift the partial clinical hold on both Vasomax and Vasofem or consider the drug's approval.