Acambis plc, of Cambridge, UK, said it completed a Phase I trial of its smallpox vaccine, ACAM1000, vs. Dryvax, the smallpox vaccine that was used during the worldwide smallpox eradication program. In the 60-subject, randomized, double-blind trial, 30 subjects were given the standard dose of Dryvax and 30 were given an equivalent dose of ACAM1000. The indication of protective immunogenicity in the case of smallpox vaccination is the development of a pock mark on the skin. This mark was seen within 10 days after vaccination in all ACAM1000-treated subjects and 97 percent of Dryvax-treated subjects.
Affymetrix Inc., of Santa Clara, Calif., said it established a wholly owned Japanese subsidiary to manage direct sales, marketing and technical support for Japan, beginning in January. The company had been working with Amersham Biosciences KK, its current commission agent in Japan, to transition GeneChip customers. Affymetrix said it has placed in Japan more than 60 GeneChip brand systems, its DNA array technology.
Amarillo Biosciences Inc., of Amarillo, Texas, said it signed an option agreement with two inventors, Chihiro Sugimoto and Takeshi Matsumura, along with Hayashibara Biochemical Laboratories Inc., Hokkaido Green-Bio Institute and Hokuren Federation of Agricultural Cooperatives, to examine the transgenic delivery of human interferon alpha through potato plants. Amarillo will evaluate the commercial possibilities of growing human interferon alpha. Financial terms were not disclosed.
Amsterdam Molecular Therapeutics BV, of Amsterdam, the Netherlands, signed a license agreement with Schering-Plough Corp., of Kenilworth, N.J., for use of interleukin-10 under Schering's patent portfolio, for ex vivo gene therapy in inflammatory diseases of the gastrointestinal tract. The agreement allows Amsterdam Molecular to develop its IL-10 ex vivo gene therapy for the maintenance of remission in Crohn's disease in collaboration with the Academic Medical Center in Amsterdam. Financial details were not disclosed.
Atrix Laboratories Inc., of Fort Collins, Colo., signed a licensing agreement with Key Oncologists Ltd. for the South African marketing rights to its Eligard (leuprolide acetate for injectable suspension) prostate cancer products. Key Oncologists will be responsible for all required regulatory submissions. Financial details were not disclosed. Eligard once-a-month and once-every-three-month products were approved in the U.S. earlier this year. (See BioWorld Today, Jan. 25, 2002.)
Avant Immunotherapeutics Inc., of Needham, Mass., appointed Lohmann Animal Health International as the exclusive distributor of its Megan Health poultry vaccines in North America. Financial terms were not disclosed. Avant is developing a portfolio of vaccines against viral and bacterial diseases. It markets Megan Vac 1, a Salmonella vaccine, as well as Megan Egg for laying hens and Antipath, an E. coli vaccine for young chickens.
BioMS Medical Corp., of Edmonton, Alberta, said its common shares will commence trading on the Toronto Stock Exchange today under the symbol MS. BioMS is listed on the TSX Venture exchange. BioMS has licensed a synthetic peptide technology, MBP8298, for the treatment of multiple sclerosis on an exclusive worldwide basis. It has undergone Phase I and II trials.
BioStratum Inc., of Research Triangle Park, N.C., said its lead product, Pyridorin, was the focus of several presentations at the 38th annual meeting of the European Association for the Study of Diabetes in Budapest, Hungary. Pyridorin has fast-track status with the FDA and is in Phase II trials for the treatment of diabetic kidney disease. Pyridorin is a small molecule that might inhibit formation of advanced glycation end-products in patients with diabetes.
Cell Pathways Inc., of Horsham, Pa., said chemical changes in a cellular protein called vasodilator-stimulated phospoprotein might provide a marker for monitoring the biological activity of Cell Pathways' selective apoptotic antineoplastic cancer drugs. Data related to this protein were published in Molecular Cancer Therapeutics. The article was co-authored by investigators at Cell Pathways. Aptosyn, Cell Pathways' cancer drug, is designed to selectively trigger the apoptosis of cancerous and precancerous cells.
CIMA Labs Inc., of Eden Prairie, Minn., said it began clinical trials of its OraVescent fentanyl product, following the FDA's receipt of CIMA's investigational new drug application at the end of July. OraVescent is an oral drug delivery technology designed to improve the absorption of drug ingredients across mucosal membranes lining the mouth. The fentanyl product incorporates the delivery technology with a drug ingredient used for treating cancer pain.
Curacyte AG, of Munich, Germany, and Gambro Dialysatoren GmbH, of Hechingen, Germany, entered an agreement under which Gambro will receive an exclusive worldwide sublicense to use Curacyte's protease inhibitors in extracorporeal blood treatment applications. Financial details were not disclosed.
Galapagos Genomics NV, of Mechelen, Belgium, said it broadened its collaboration with Procter & Gamble Pharmaceuticals, a division of Procter & Gamble Co., of Cincinnati, under which Procter & Gamble will use Galapagos' adenoviral gene expression technology to validate the use of genes as drug targets in endocrinology, cardiovascular and musculoskeletal diseases. Financial terms were not disclosed. The companies entered their original agreement in October 2001.
Generex Biotechnology Corp., of Toronto, presented data at the 38th annual meeting of the European Association for the Study of Diabetes in Budapest, Hungary. The data suggest that Oralin, Generex's oral insulin spray, might be a safe and effective replacement for injected insulin in the treatment of Type I and Type II diabetes. Oralin is delivered to the buccal cavity via Generex's RapidMist device.
Geron Corp., of Menlo Park, Calif., published research describing the differentiation of cardiomyocytes from human embryonic stem cells. The studies show that functional, contractile cardiomyocytes can be differentiated from human embryonic stem cells and have potential for clinical use in treating diseases such as acute myocardial infarction and heart failure. The information was published in the September 2002 issue of Circulation Research.
Interleukin Genetics Inc., of Waltham, Mass., said it signed a letter of intent with an undisclosed consumer products company to develop and market genomics-based nutritional and skin-care products. The parties executed a letter of intent that, in exchange for an undisclosed sum, permits the nutrition company a limited period in which to evaluate the option of entering a joint venture or executing a licensing agreement in the area of nutritional genomics. The arrangement allows Interleukin Genetics to continue its business development activities for the diagnostic and therapeutic applications of the company's technology.
KuDOS Pharmaceuticals Ltd., of Cambridge, UK, completed a £29.5 million (US$45 million) third round of private equity funding. A large portion of the funding will be used for clinical studies of KuDOS' two lead products, PaTrin-2 and AQ4N. The round was led by EuclidSR Partners, of New York. Other investors included Johnson & Johnson Development Corp., LSP-Life Sciences Partners, of the Netherlands and Germany, and BankInvest Biomedical Venture, of Denmark. KuDOS' existing UK-based investors - Advent Venture Partners, Schroder Ventures Life Sciences and 3i Group plc - also contributed.
Novuspharma SpA, of Bresso, Italy, and Micromet AG, of Munich, Germany, entered an alliance to co-develop Micromet's drug candidate, MT201, a human antibody that targets the Ep-CAM molecule. The product is in Phase I studies in patients with hormone-refractory prostate cancer. The partners will pursue a Phase II program with up to 1,000 patients in major cancer indications. The program will begin in 2003. The companies will share future costs and revenue streams and Micromet will receive €4 million up front and, potentially, milestone payments and royalties.
OxiGene Inc., of Watertown, Mass., said results of a study demonstrate the antitumor potential of its lead preclinical compound, Oxi4503, as a single-agent therapy. The findings were published in the most recent issue of Anticancer Research. Researchers concluded that in mouse models of human breast cancer, Oxi4503 reduced tumor volume and retarded growth in established tumors. OxiGene's stock (NASDAQ:OXGN) rose 24 cents Tuesday, or 22.9 percent, to close at $1.29.
Paratek Pharmaceuticals Inc., of Boston, received a Phase I Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health in Bethesda, Md. The grant was awarded for screening tetracycline derivatives for activity against Plasmodium falciparum. The company said it is now applying for a Phase II grant.
PhotoCure ASA, of Oslo, Norway, finished a multicenter Phase III study of Hexvix in the detection of bladder cancer. The trial examined 211 patients who had a high risk of bladder cancer. The company said that in a majority of patients with flat cancer lesions, more patients with bladder cancer were found with Hexvix than with standard white light cystoscopy. Hexvix also has an excellent safety profile, PhotoCure said.
Pyrosequencing AB, of Uppsala, Sweden, said it was granted access to intellectual property covering the use of the RNase P gene for identifying clinically relevant bacteria by Bioimics AB. It has been granted an option from Bioimics for an exclusive worldwide license to the RNase P gene for detecting pathogenic organisms. Pyrosequencing also would have rights to sublicense the target to collaborators. Also, Pyrosequencing will fund a research project in which Bioimics will use Pyrosquencing's PSQ 96 System to sequence the Endoriboclease P (RNase P) gene in various microorganisms to validate its use for identifying clinically relevant bacteria.
SurroMed Inc., of Mountain View, Calif., entered a pilot biomarker discovery collaboration with Eli Lilly and Co., of Indianapolis. Lilly will supply preclinical samples for analysis in SurroMed's Biomarker Discovery Laboratory using its integrated mass spectrometry-based platform for proteomic and small organic molecule analysis in order to identify biomarkers of disease. Financial terms were not disclosed.
TransForm Pharmaceuticals Inc., of Lexington, Mass., relocated to a 59,000-square-foot facility in Lexington. The facility includes laboratories to support the company's high-throughput pharmaceutical form and formulation platforms and internal product development efforts. It also will house administrative offices. The company was previously located in Waltham, Mass.
Valentis Inc., of Burlingame, Calif., said it would extend the tender period of its tender offer to purchase 16,940 shares - or 55 percent of its outstanding shares of Series A convertible redeemable preferred stock and 55 percent of the related outstanding common stock purchase warrants - Class A and common stock purchase warrants, to Oct. 15. The company will pay $1,000 per share of Series A preferred stock and related Class A and Class B warrants tendered. The tender period is being extended to allow time for the satisfaction of certain conditions related to the tender offer, Valentis said.
Vernalis Group plc, of Berkshire, UK, said a study demonstrated the benefits of using frovatriptan, its approved antimigraine treatment, in the prevention of menstrually associated migraine headaches. The trial was conducted at 36 sites in the U.S. and involved more than 500 menstrual migraine sufferers. Results show that both 2.5 mg and 5 mg of frovatriptan were effective in reducing the incidence, severity and duration of migraines, compared to placebo.