What happened is the nurses accidentally OD’s the patients in the clinical trial, although the patients were not harmed. 5days medicine in 5hours. Huge mistake due to lack of training on the pump that administers the drug and the FDA caught it and made them start all over again with the trial, even though the results were successful.

It led to a new discovery that Genasense(R) Can be Administered by Brief High-Dose IV Infusion !!!!!

It is very positive for the company and will be presented at ’09 ASCO

New Trial Reaffirms Primacy and Safety of ‘First Generation’ Antisense

BERKELEY HEIGHTS, N.J., Oct. 23 /PRNewswire-FirstCall/ — Genta Incorporated (Nasdaq: GNTA) announced the presentation of new data showing that Genasense(R) (oblimersen sodium) Injection, its lead anticancer compound, can be safely administered in high doses by a brief intravenous (IV) infusion. The new data were presented by Dr. Anthony Tolcher, Director of Clinical Research, South Texas Accelerated Research Therapeutics (START), and Clinical Professor of Medicine, University of Texas Health Science Center, San Antonio, TX. The presentation was made during the “Molecular Targets and Therapeutics” meeting in San Francisco, CA, which was jointly sponsored by the U.S. National Cancer Institute (NCI), the American Association for Cancer Research (AACR), and the European Organization for the Research and Treatment of Cancer (EORTC).

High-dose IV injections of so-called “first generation” antisense compounds, known as phosphorothioates, have been associated with severe toxicity in monkey studies. As a consequence, clinical use of these drugs has sought to avoid high plasma concentrations by using continuous IV administration of low doses. During its Phase 3 clinical trials, Genta developed a safety database involving patients who tolerated accidental overdoses, which suggested that the animal experience might not be clinically predictive. Additional preclinical data have also suggested that intermittent high-dose injections are associated with equal or superior antitumor efficacy. The Company has now developed clinical data that establishes Genasense can be safely administered by both subcutaneous injection as well as brief IV infusion.

What happened is the nurses accidentally OD’s the patients in the clinical trial, although the patients were not harmed. 5days medicine in 5hours. Huge mistake due to lack of training on the pump that administers the drug and the FDA caught it and made them start all over again with the trial, even though the results were successful.

It led to a new discovery that Genasense(R) Can be Administered by Brief High-Dose IV Infusion !!!!!

It is very positive for the company and will be presented at ’09 ASCO

New Trial Reaffirms Primacy and Safety of ‘First Generation’ Antisense

BERKELEY HEIGHTS, N.J., Oct. 23 /PRNewswire-FirstCall/ — Genta Incorporated (Nasdaq: GNTA) announced the presentation of new data showing that Genasense(R) (oblimersen sodium) Injection, its lead anticancer compound, can be safely administered in high doses by a brief intravenous (IV) infusion. The new data were presented by Dr. Anthony Tolcher, Director of Clinical Research, South Texas Accelerated Research Therapeutics (START), and Clinical Professor of Medicine, University of Texas Health Science Center, San Antonio, TX. The presentation was made during the “Molecular Targets and Therapeutics” meeting in San Francisco, CA, which was jointly sponsored by the U.S. National Cancer Institute (NCI), the American Association for Cancer Research (AACR), and the European Organization for the Research and Treatment of Cancer (EORTC).

High-dose IV injections of so-called “first generation” antisense compounds, known as phosphorothioates, have been associated with severe toxicity in monkey studies. As a consequence, clinical use of these drugs has sought to avoid high plasma concentrations by using continuous IV administration of low doses. During its Phase 3 clinical trials, Genta developed a safety database involving patients who tolerated accidental overdoses, which suggested that the animal experience might not be clinically predictive. Additional preclinical data have also suggested that intermittent high-dose injections are associated with equal or superior antitumor efficacy. The Company has now developed clinical data that establishes Genasense can be safely administered by both subcutaneous injection as well as brief IV infusion.