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Biotech / Medical : EntreMed (ENMD) -- Ignore unavailable to you. Want to Upgrade?

To: Don Dorsey who wrote (1947)	7/13/1999 12:08:00 PM
From: Don Dorsey	Read Replies (1) \| Respond to of 2135

Tetrionics to Manufacture Antiangiogenic Drug Substance 2ME2 for EntreMed, Inc. MADISON, Wis.--(BUSINESS WIRE)--July 13, 1999--Tetrionics, Inc. will manufacture 2-methoxyestradiol (2ME2) for EntreMed, Inc.'s (NASDAQ: ENMD) preclinical testing. EntreMed, The Angiogenesis Company(TM), has a CRADA in place with the National Cancer Institute to further develop 2ME2. Preliminary data indicate 2ME2 is an effective, orally-active antitumor compound. Timelines for development of 2ME2 are aggressive. EntreMed anticipates submission of an Investigational New Drug (IND) application to the FDA in Q4 1999. Prior to that submission, EntreMed must complete its IND-directed preclinical studies. "Tetrionics has given extra effort to meet our delivery needs and our strict purity profile," stated Dr. Shawn Green, EntreMed's Vice President of Discovery Research. A gratis sample of 2ME2 was supplied to EntreMed for confirmation of the product's specifications prior to order placement. Tetrionics manufactures 2ME2 to purities greater than 99.9%. Dr. Shawn J. Green, commented on EntreMed's first small molecule product candidate: "2ME2 is the first product candidate from EntreMed to attack both compartments of cancer, the tumor cells and their blood supply. 2ME2 is orally active at inhibiting the growth of metastatic and primary cancerous tumors in experimental rodent models. In these preclinical models, 2ME2 has shown no overall toxicity at therapeutically effective doses." Dr. Green continued, "While an estrogen derivative, studies of 2ME2 failed to show any of the several effects associated with hormone treatment, such as uterine growth, carcinogenesis, or inhibition of white blood cell formation. Further, in sharp contrast to conventional chemotherapeutics, 2ME2 targets rapidly growing cells with relative high specificity and does not kill non-dividing cells. In addition to its marked effects on stopping the growth of malignant cells, 2ME2 also acts as a potent inhibitor of angiogenesis by restricting development of the blood vessels that transport life-sustaining nutrients to tumors." As with any drug manufacturing process, there are potential problems associated with contamination. To eliminate these risks, Tetrionics relies primarily on total isolation of active compounds. "Strict adherence to Standard Operating Procedures governing the handling and packaging of potent pharmaceutical products minimizes any possibility of accidental exposure and cross contamination," said Tetrionics Vice President, Dr. Herb Paaren. Tetrionics has been handling highly potent compounds for ten years and has never had a safety violation. Tetrionics, a privately owned company, is rapidly expanding in both the Active Pharmaceutical Ingredient (API) synthesis arena and early stage drug development. Over 30 different API's have been manufactured by Tetrionics and seven have been tested in human clinical trials. Current commercial production includes Paracalcitol, an API approved for marketing clearance by the FDA for Abbott Laboratories' Zemplar(R) product in 1998. A success story of the MG&E Innovation Center, Tetrionics has won several Wisconsin Small Business Awards for innovation and outstanding achievements.