Aphton Corp., of Miami, said interim analysis from a trial showed that 82 percent of patients had either tumor shrinkage or stable disease in its trial of metastatic stomach cancer patients treated with its G17DT and chemotherapy consisting of cisplatin and 5FU. Of 73 evaluable patients, two showed a complete response, 35 had a partial response and 23 reported stable disease. The 37 patients presenting partial or complete responses represent an overall tumor response rate of 51 percent. The data follow interim response results reported at May's meeting of the American Society of Clinical Oncology showing an overall tumor response rate of 48.3 percent, followed by an interim report on July 31 showing an overall tumor response rate of 51.4 percent. Throughout the trial, no systemic toxicity has been attributed to G17DT, Aphton said. Its stock (NASDAQ:APHT) gained 49 cents Thursday, or 16 percent, to close at $3.55.
Arius Research Inc., of Toronto, disclosed positive preclinical results for a series of anticancer antibodies, at the 2003 Keystone Symposium on Antibody-Based Therapeutics for Cancer in Banff, Alberta. Arius' antibody generation and screening program has produced a cohort of antibodies that are active in breast, colon, ovarian and prostate cancers. Two of them, AR7BD-33-11A and AR1A245.6, have progressed into animal models and have successfully prevented growth of human breast cancer, the company said. The antibodies also are being studied in prostate cancer.
Auxeris Therapeutics Inc., of St. Louis, appointed Laurent Fischer president and CEO. Fischer has both commercial and product development experience. He served as vice president of corporate development and chief medical officer of MedVantx Inc., a specialty pharmaceutical supply-chain management company. He also was senior vice president of DuPont-Merck Inc. and DuPont Pharmaceuticals, where he launched the anti-HIV drug, Sustiva.
Blue Heron Biotechnology Inc., of Bothell, Wash., was awarded a $2.4 million grant from the National Institute of General Medical Sciences, a unit of the National Institutes of Health in Bethesda, Md. The Phase II Small Business Innovation Research grant is designed to accelerate Blue Heron's ongoing research in gene synthesis and enhance its GeneMaker automated gene synthesis platform. Commercially launched in early 2001, GeneMaker was developed to provide full-length genes on a fee-for-service basis.
Cephalon Inc., of West Chester, Pa., said the FDA accepted an abbreviated new drug application from another company for a generic form of modafinil, the active ingredient in the company's Provigil tablets. Provigil was approved by the FDA for the treatment of excessive daytime sleepiness associated with narcolepsy in December 1998 and was launched in the U.S. by Cephalon in February 1999. Cephalon said it doesn't expect a generic equivalent to be on the markets for years, given that its modafinil patent does not expire until 2014, and that its orphan drug status remains in effect until at least June 2006. (See BioWorld Today, Dec. 28, 1998.)
Discovery Partners International Inc., of San Diego, entered an agreement with GlaxoSmithKline plc, of London, for the delivery of a next-generation IRORI Combinatorial Chemistry Synthesis Platform. Financial terms of the agreement were not released. Over the next 12 months, Discovery Partners will deliver the first two next-generation X-Kan Chemistry Synthesis Systems for use at GSK sites in the UK and the U.S.
Entropin Inc., of Indio, Calif., said it would vigorously defend claims brought in a lawsuit against the company, one of its officers and one of its directors. The class-action lawsuit alleges violations of federal and California securities laws. Entropin, which is developing compounds to treat pain, said the claims are meritless.
EquiTech Corp., of Edmonton, Alberta, said it would submit to the FDA an investigational new drug application for its lead candidate, ZAG-1701. EquiTech plans to investigate the safety, tolerability and efficacy of ZAG-1701 in two groups - initially in dental patients who have undergone wisdom tooth extraction, with follow-on studies that may include migraine sufferers. To provide assistance with the IND submission, EquiTech hired CanReg Inc., of Dundas, Ontario, a regulatory affairs and market access consulting firm.
GenStar Therapeutics Corp., of San Diego, and Vascular Genetics Inc., of Atlanta, reported the completion of their merger to form Corautus Genetics Inc. The combined company will trade on the American Stock Exchange under the symbol "CAQ" starting at noon Friday. Corautus Genetics was created to capitalize on the complementary strengths of GenStar and VGI to accelerate the development of a later-stage genetic therapy for cardiovascular disease. The company's focus will be the development of gene therapy products using vascular endothelial growth factor 2 (VEGF-2). (See BioWorld Today, Sept. 16, 2003.)
Gradipore Ltd., of New York, said its Gradiflow technology was proven to successfully concentrate and remove infectious and non-infectious prion proteins from human biological samples in laboratory studies. The results were from experiments designed, performed and validated in collaboration with the Scottish National Blood Transfusion Service and Q-One Biotech Ltd., of Glasgow, Scotland. Gradipore said it submitted an abstract to present full results at an unspecified forum later this year.
IBM Corp., of Armonk, N.Y., released DB2 Information Integrator and DB2 Information Integrator Content, data management software designed to help its customers access, integrate and analyze wide-ranging information. IBM said such software could provide companies an infrastructure that allows them to test hypotheses across data stored in relational databases, genomic and proteomic data stores and other sources.
Immtech International Inc., of Vernon Hills, Ill., said it completed enrollment in its Phase IIa pilot trial using the oral drug candidate DB 289 to treat Pneumocystis carinii pneumonia, caused by a life-threatening fungus that overgrows the air sacks of the lungs of immunosuppressed people. The study protocol requires each patient to orally take DB289 twice a day for 21 days. Only patients who have failed due to the toxicity of the standard drug therapy using Trimethoprim-Sulfamethoxazole are enrolled in the trial. Immtech said it expects to report safety and efficacy findings next month, after the last patient has completed treatment and clinical data have been compiled.
MelTec GmbH, of Magdeburg, Germany, entered a collaboration to study rheumatoid arthritis with the Proteome Center Rostock. As part of a feasibility study, they will apply MelTec's MELK technology to tissue samples collected from inflamed human joints. Depending on results, the collaboration could expand to use topological proteomics - toponomics - for the discovery of biomarkers and targets in RA. The Proteome Center Rostock is part of the Proteome Alliance, a research network of more than 20 industrial and academic groups supported by the German Ministry for Education and Research. Financial terms were not disclosed.
NexMed Inc., of Robbinsville, N.J., raised $533,489 in interim financing through the exercise of 389,408 warrants to purchase shares of its common stock for $1.37 apiece. The exercise price was lowered from $4.08 per share and instead based on a 5 percent premium to an average market price of NexMed stock prior to the Feb. 4 exercise.
NPS Pharmaceuticals Inc., of Salt Lake City, said at the Merrill Lynch conference in New York that its manufacturing capabilities should produce sufficient supply of Preos, its lead drug candidate to treat osteoporosis, for completing all ongoing clinical studies. Included among the studies is the Phase III TOP (treatment of osteoporosis with PTH) study - on track for conclusion in September. Also included is the PaTH (PTH and alendronate) study, for which NPS said it has yet to receive data from the National Institutes of Health in Bethesda, Md., and the University of California at San Francisco, which are running the trial. NPS said it is beginning to prepare for the commercial launch of Preos. NPS said it is reviewing data from its pilot Phase II study of another product, ALX-0600, in adults with short bowel syndrome. It is designing the next trial, expected to begin by the end of this year, to be a pivotal study for that indication.
Oncolytics Biotech Inc., of Calgary, Alberta, said it completed its program for the development of a commercial process for the manufacturing of Reolysin, a human reovirus being developed as a potential cancer therapeutic. Oncolytics said that at the current scale of operations, one manufacturing run should supply sufficient material for all expected clinical studies for the next two years.
PhotoCure ASA, of Oslo, Norway, launched in Germany Metvix PDT, a photodynamic therapy for the treatment of actinic keratosis and basal cell carcinoma. The product is being marketed by Galderma SA, PhotoCure's partner outside the Nordic countries.
Praecis Pharmaceuticals Inc., of Waltham, Mass., reported more detailed results from its trial of Plenaxis (abarelix for injectable suspension) in the treatment of advanced, symptomatic prostate cancer. The company presented data at the 7th International Symposium on GnRH Analogues in Cancer and Human Reproduction in Amsterdam, the Netherlands. Early results from the trial were previously presented at the 2001 Annual Meeting of the American Society of Clinical Oncology. The primary endpoint was the avoidance of surgical castration at four and 12 weeks, which was met by 100 percent of the patients. In addition, no patient required surgical castration during the follow-up phase of the study, which had a median duration of 40 weeks.
PrimaBioMed Ltd., of Victoria, Australia, said its subsidiary, Panvax Ltd., generated new data from sheep tests confirming the potential of its DCtag delivery technology against diseases, including cancer, malaria, tuberculosis and viral diseases. DCtag is Panvax's platform technology with the potential to boost the immune responses to vaccine and immunotherapy products being developed for both human and animal health. PrimaBioMed focuses on immunology and cancer immunotherapy.
ProMetic Life Sciences Inc., of Montreal, and the American Red Cross Plasma Services, of Washington, established a strategic alliance to co-develop a protein-purification process using technologies from both to recover the most valuable therapeutic proteins from plasma. The purpose of the agreement is to provide the technology to the Red Cross and, under license, other parties. ProMetic and the Red Cross will generate royalties on the sales of the therapeutics produced from the process. Other financial details were not disclosed.
Pro-Pharmaceuticals Inc., of Newton, Mass., initiated Phase I trials of its Davanat-1 product candidate. The multicenter, open-label study is for all patients with solid tumors who have failed surgical, radiation and chemotherapeutic regimens.
Tm Bioscience Corp., of Toronto, received a milestone payment from Luminex Corp., of Austin, Texas, related to the commercial launch of the Tm 100-based Universal Array by Luminex. The launch also initiated a royalty stream from Luminex to Tm Bioscience on sales of the array, a microsphere-based product using Luminex's xMAP technology, resulting in a platform designed for the development of high-throughput genetic tests.
Vical Inc., of San Diego, labeled a DNA-based vaccine against cytomegalovirus, its first independent development program focused on infectious diseases. Vical said it plans to begin by the end of this year Phase I testing of the vaccine for an initial indication in humans at greatest risk of serious complications from CMV infection - patients undergoing bone marrow or solid organ transplantation. Vical said future development could lead to a vaccine for immunocompromised individuals, women of reproductive age, and eventually, to a universal vaccine for pediatric use.
Xpogen Inc., of Cambridge, Mass., licensed PathlinX 3.0 to the Sloan-Kettering Institute, the research arm of the Memorial Sloan-Kettering Cancer Center in New York. Xpogen's PathlinX 3.0 is designed to identify differentially co-expressed genes in two-state experiments (diseased vs. non-diseased) to help researchers uncover mechanisms of action. The institute said the software would allow it to integrate clinical and research data to help classify cancers through the identification of new markers. Separately, Xpogen said it also licensed PathlinX 3.0 to McLean Hospital, a psychiatric teaching and research facility of Harvard University and an affiliate of Massachusetts General Hospital. At McLean, the software will be used to help uncover differences in gene-to-gene relationships between healthy and diseased brain tissues.