BioMed News Bytes: Genta (OTC: GETA.OB) to Report Phase 3 Genasense Results Print E-mail
Wednesday, 28 October 2009 17:04

The FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response letter (CRL) re-submissions to the FDA; and (4) pending clinical trial results.

Genta Inc. (OTC: GETA.OB) will host a conference call and live audio webcast to review top-line results of its AGENDA Phase 3 trial of Genasense (oblimersen sodium) Injection in patients with advanced melanoma on 10/29/09 at 8am ET. On 7/14/09, Genta announced the publication of a paper that independently confirms the link of a key biomarker to overall survival in patients with advanced melanoma. The biomarker, a tumor-derived enzyme known as lactate dehydrogenase (LDH), is measured by a widely available blood test. The Phase 3 AGENDA study has specified low-normal LDH as an enrollment criterion and the co-primary endpoints in this trial include progression-free survival (PFS) and overall survival (OS).

On 5/19/09, Genta announced that the independent Data Monitoring Board (DMB) for AGENDA notified the Company that the study passed its final futility analysis for progression-free survival (PFS). Accordingly, the Board has recommended that the study should continue to completion. On 7/13/09, Genta began trading under a new ticker (GETA.OB) after implementing a previously announced one-for-fifty reverse stock split of its common stock which reduced the number of outstanding shares from about 5.4 billion to around 108 million shares.

Neurocrine Biosciences (NASDAQ: NBIX) held a Type C meeting with FDA in August to discuss the non-menstrual pelvic pain scale proposed by the Agency and used in the Lilac Petal Study (0702). Based on this meeting, the Company modified the wording of the non-menstrual pain daily scale and launched a new clinical trial, the Daisy Petal Study (0901). This double-blind placebo-controlled clinical trial is designed to provide an assessment of this modified scale over a two month treatment period of 150 mg elagolix, followed by 20 weeks of open-label treatment.

NBIX expects to report top-line data from the Daisy Petal Study (0901) during 2Q10. The Tulip Petal Study (0703) has completed subject randomization (n=174) and treatment through Week 12 in Central Eastern Europe. This study is designed as a randomized, double-blind, placebo and active controlled trial with four treatment arms; elagolix 150 mg, elagolix 250 mg, leuprolide depot, and placebo. NBIX expects top-line data based on the first three months of placebo and active controlled treatment to be available later in 4Q09.

On 10/28/09, Cyclacel Pharma (NASDAQ: CYCC) announced top-line survival data for the primary endpoint of the Phase 2 study of sapacitabine as a treatment for elderly patients aged 70 or older with either newly diagnosed acute myeloid leukemia (AML) or AML in first relapse. The study was a three-arm randomized trial evaluating three dosing schedules of sapacitabine. The primary endpoint of 1-year survival is approximately 30% each on two out of the three schedules tested. Details of the results from this study will be presented at an upcoming medical conference. CYCC is currently working with the FDA to design a Phase 3 registration study for sapacitabine in patients with hematological malignancies.

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