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Genta Incorporated Message Board

  • rx_engineer rx_engineer Jan 1, 2002 4:13 PM Flag

    Take stock in passed years' events


    Symbol: GNTA

    Science is strong - down regulation of target protein by an ANTISENSE mechanism to bind messenger RNA and interrupt the further production of BCL-2, a protein that inhibits normal cell self-destruction, known as APOPTOSIS, allowing cancer cells to naturally die off.

    Management is SMART, SOUND & ETHICAL - No hype until technology is proven by Science.

    Safety profile of G3139 is mild compared to existing cancer therapies: Radiation, Chemotherapy & Immunotherapy and causes much less collateral damage to healthy cells.

    G3139 will be marketed as an adjunct therapy to the three forms of existing therapy: Radiation, Chemotherapy & Immunotherapy, since these treatments act to differentiate cancer cells so that they proceed through the BCL-2 �GATE' and down the Apoptosis pathway to be eliminated from the body, through natural cell death. G3139 will not replace conventional therapy, it will become a partner to all three forms in a variety of cancer conditions by opening the GATE that BCL-2 blocks.

    Management has involved FDA in the design of the protocols for the pivotal clinical studies.

    Publication in the Journal of Molecular Medicine reported that preclinical data that showed that Genasense(TM), markedly increased the anticancer activity of cisplatin (Platinol�; Bristol Myers Squibb, Inc.) in a preclinical model of stomach cancer. In the new study reported by investigators from the University of Vienna, Genasense(TM) was given either alone and or in combination with cisplatin to mice implanted with human stomach cancer. While Genasense(TM) and cisplatin used alone both demonstrated a moderate increase in antitumor activity compared with controls, combined Genasense(TM)/cisplatin therapy showed a 70% greater antitumor effect compared with cisplatin alone. Moreover, survival was increased by more than 50% without any increase in side-effects. Dr. Raymond P. Warrell, Genta's Chief Executive Officer also observed: ``On a worldwide basis, stomach cancer is an enormous public health problem. These new data will be especially valuable to our ex-U.S. licensee for Genasense(TM), and they point to an obvious early strategy for clinical development in Asia.''

    ``The Company's Gensysnergy(TM) {aka Alice} project is our preclinical initiative that evaluates the ability of Genasense(TM) to amplify the activity of virtually all types of existing anticancer therapies,'' commented Dr. Robert E. Klem, Genta's Vice President and Chief Scientific Officer, who also commented: ``To our knowledge, the results of this program exceed by a very wide margin the synergy testing that has been conducted using any other antisense agent. To date, results of this ongoing program show that Genasense(TM) synergizes with 17 different anticancer drugs (including cytotoxics, steroids, interferons, monoclonal antibodies, gene therapy, and other antisense molecules), plus radiation and photodynamic therapy.''

    Phase I studies (blood level studies) with G3139 have demonstrated tumor size reductions even though not the objective of these types of studies. In combination & single agent dose-raning studies, administration at the higher doses of Genasense resulted in tumor cell lysis, a toxic physiological condition where the patients are overwhelmed by destroyed cancers cells because they can not adequately metabolize or eliminate them.

    G3139 will be used in combination therapies 1st which will be more likely to be approved by FDA if clinical data is as good as expected. And, greatly accepted by clinical oncologists in the trenches since G3139 extends the usefulness of existing therapies.

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