* Advanced Viral Research Corp., of Yonkers, N.Y., received approval in Argentina to begin Phase III trials of its lead drug, Reticulose, for HIV and human papilloma virus. The antiviral drug is described by the company as a "peptide nucleic acid with immunomodulator activity."

* Alliance Pharmaceutical Corp., of San Diego, began a Phase III trial of Imagent, a contrast agent designed to enhance ultrasound images in echocardiograms for diagnosis of heart function. Imagent, an aqueous dispersion of microbubbles with a mixture of perfluorochemical vapor and a physiological gas, is under development in partnership with Schering AG, of Berlin.

* Aphton Corp., of Woodland, Calif., said its scientists in collaboration with researchers at the University of Toronto and the University of South Carolina, in Columbia, have identified new breast cancer genes through a technique of profiling gene expression involved in the progression of the malignancy. The work is part of the firm's breast cancer genome anatomy project.

* CollaGenex Pharmaceuticals Inc., of Newtown, Pa., said it submitted an amended new drug application (NDA) to the FDA for Periostat, a periodontal disease therapy. The company originally filed its NDA in September 1996, but the FDA subsequently sought clarification of the statistical methodology used in clinical trials of the oral collagenase inhibitor. In the amended NDA Collagenex is seeking to market Periostat based on data showing it could significantly enhance clinical benefits of scaling and root planing.

* Cytogen Corp., of Princeton, N.J., said data from a multicenter study of its FDA-approved analgesic, Quadramet, showed the drug provided significant pain relief to patients whose prostate and breast cancers had spread to their bones. The findings were published in the April issue of the Journal of Clinical Oncology. Quadramet is marketed by the Dupont Merck Pharmaceutical Co., of Wilmington, Del. Quadramet (Samarium Sm 153 Lexidronam Injection) is a radiopharmaceutical drug that targets the bone and concentrates in areas that have been invaded with tumor.

* Genentech Inc., of South San Francisco, Calif., said the FDA granted fast-track status to the humanized monoclonal antibody, Herceptin, for metastatic breast cancer. The drug is an antibody to the HER2 growth factor receptor, which is overexpressed in breast cancer cells. Fast track status enables the FDA to speed development and review of drugs. Genentech expects to file a biologics license application for Herceptin during the second quarter of this year.

* Genetix Pharmaceuticals Inc., of Cambridge, Mass., said preclinical studies of its anti-angiogenic gene therapy showed the treatment was able to stop blood flow to cancer tumors in mice. The company said the therapy involves delivery of genes that produce two angiogenesis inhibiting proteins.

* Gliatech Inc., of Cleveland, said it is developing histamine H3 receptor antagonists for treatment of obesity and other eating disorders. Histamine is a neurotransmitter that regulates central nervous system responses, including those involved in sleep, arousal and body weight. The company's researchers said certain compounds specific for the H3 receptor have demonstrated they can promote the release of histamine in areas of the brain involved in body weight.

* Hyseq Inc., of Sunnyvale, Calif., and Chiron Corp., of Emeryville, Calif., said they have filed patent applications for 2,200 genes found through their cancer gene discovery efforts. Using Hyseq's sequencing by hybridization techniques, the two companies began analyzing diverse cancerous tissues in May 1997. Under their agreement, Hyseq will receive from Chiron milestone and royalty payments on drugs and new genetic targets emanating from the research.

* Incyte Pharmaceuticals Inc., of Palo Alto, Calif., signed an agreement with Bayer AG, of Lerverkusen, Germany, to provide the pharmaceutical company access to Incyte's LifeTools bioinformatics software. Bayer will use the technology to integrate gene-based drug discovery work at its various laboratories in the U.S., Germany, U.K. and Japan. Bayer also will become a subscriber to Incyte's LifeSeq database of gene sequences and expression information. Financial terms were not disclosed.

* Interneuron Pharmaceuticals Inc., of Lexington, Mass., said data from three placebo-controlled, blinded studies of the company's anti-obesity drug, Redux (dexfenfluramine), showed no statistically significant difference in incidence of cardiac valve abnormalities among patients receiving the drug and placebo. A total of 1,072 patients were involved in the trials. The studies were the first well-controlled, blinded trials to assess Redux's effect on heart function since the drug was withdrawn from the market in September 1997, following reports of cardiac value abnormalities by Redux users. Interneuron's marketing partner for Redux is American Home Products Corp., of Madison, N.J.

* Magainin Pharmaceuticals Inc., of Plymouth Meeting, Pa., said preclinical trials of its angiogenesis inhibiting drug, squalamine, showed it was effective in an animal model of lung cancer when used in combination with chemotherapeutic agents cisplatin or carboplatin. Squalamine is in Phase I trials. The drug is derived from tissues of the dogfish shark.

* Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said data from a Phase I/II trial of its cancer vaccine, MGV, for high-risk melanoma and sarcoma yielded encouraging results. The vaccine is designed to control and eradicate residual cancer cells following surgery, radiation or chemotherapy. MGV is based on cancer antigens called GM2 and GD2 gangliosides, which are present in many tumors.

* Ribi ImmunoChem Research Inc., of Hamilton, Mont., said its melanoma vaccine, Melacine, has been granted expeditied review by the European Agency for Evaluation of Medicinal Products. The drug could receive European marketing clearance by the end of 1998. Melacine consists of lysed, purified cells from two human melanoma cell lines with a broad array of melanoma antigens, combined with Ribi's proprietary Detox adjuvant, which contains monophosphoryl lipid A and mycobacterial wall skeleton to stimulate the immune system.

* Schering-Plough Corp., of Madison, N.J., said data from a Phase I trial of its p53 tumor suppressor gene therapy has shown the treatment's ability to achieve p53 gene expression in cancer patients following intrahepatic, intraperitoneal and intratumoral administration. The gene therapy is designed to restore normal tumor suppression to cancer cells lacking deficient p53 gene activity. Schering-Plough acquired the p53 gene therapy program in its takeover of Canji Inc., of San Diego, in 1994.

* Sequus Pharmaceuticals Inc., of Menlo Park, Calif., said animal studies of the company's SPI-077, a liposomal formulation of the chemotherapeutic cisplatin, showed the drug improved antitumor activity of cisplatin and increased concentrations of the drug at tumor sites. The company also said a Phase I trial of SPI-077 has demonstrated the drug was well tolerated at doses exceeding standard administrations of cisplatin alone. A Phase II trial is under way in non-small-cell lung cancer patients.

* Techniclone Corp., of Tustin, Calif., began a Phase I trial of 131I-chTNT-/B, a radioactive chimeric monoclonal antibody for malignant glioma. The product is based on Techniclone's Tumor Necrosis Therapy (TNT), which is designed to target cancerous cells and avoid healthy cells.

* Vaxcel Inc., of Atlanta, a subsidiary of CytRx Corp., also of Atlanta, licensed rights to genetically engineered and mutated beta-human chorionic gonadotropin proteins for treatment and prevention of cancer. The proteins, expressed by many types of cancers, are targeted for use as therapeutic vaccines and will be combined with Vaxcel's Optivax copolymer adjuvant technology.

No Comments