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Genta Incorporated Announces Fourth Quarter and Year End 2007 Financial Results and Corporate Highlights
Date:3/12/2008

termittent dosing by both subcutaneous injection and brief (1-2 hour) intravenous (IV) infusion. The maximally tolerable dose (MTD) on a once-per-week for 3 weeks schedule was identified. The follow-on study using the MTD administered on a twice-per- week for 3 weeks schedule has also been completed.

Genta expects to incorporate this new schedule into the ongoing melanoma trial with Abraxane(R) and Temodar(R). These new schedules may ultimately obviate the need for treatment via continuous IV infusion. Abstracts describing results of these studies have been submitted to the 2008 ASCO meeting.

G4544, A New Oral Drug for Skeletal Diseases, Enters Clinical Trials

In late 2007, Genta completed the initial Phase 1 study of G4544, the Company's proprietary small molecule that is intended to treat diseases associated with accelerated bone loss. G4544 contains the active ingredient in Ganite(R), a highly effective drug whose market potential has been constrained by a requirement for continuous IV infusion. No drug-related adverse experience was observed in 30 subjects who received G4544 over a 5- fold dosing range. Further clinical and pharmacokinetic results have been submitted to the 2008 ASCO meeting.

G4544 Development Strategy: The Company has improved the G4544 manufacturing process. Following review and approval of this change, Genta will seek FDA guidance on the 505(b)(2) regulatory pathway, which may shorten development time by allowing use of bioequivalence studies rather than trials to demonstrate efficacy and safety. In this case, Genta owns the NDA for Ganite and has exclusive ownership of important trade secrets, including but not limited to detailed pharmacokinetics and long-term animal toxicology of the active ingredient. The 505(b)(2) approach enables potential approval in the currently approved indication (cancer-related hypercalcemia), in parallel with development in other indications. Low doses of the active ingredient have als
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For the screening and detection by indirect immunofluorescence (IF) of primarily anti-myelin associated glycoproteins (anti-MAG) and other glycolipid autoantibodies in human serum....
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