|BioMed News Bytes: Genta (OTC: GETA.OB), Transcept (NASDAQ: TSPT)|
|Thursday, 29 October 2009 08:29|
The BioMedReports.com 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.
On 10/29/09, Transcept Pharma (NASDAQ: TSPT) announced that the FDA issued a Complete Response Letter (CRL) for Intermezzo, with a NDA that seeks approval for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. The FDA indicated that the intended use of Intermezzo in the middle of the night represents a unique insomnia indication and dosing strategy for which safety has not been previously established and the Agency requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of residual effects, with particular reference to next day driving ability. The FDA also expressed two concerns regarding the possibility of patient dosing errors in the middle of the night that could lead to next day residual effects.
Specifically, the FDA has asked Transcept to address methods to avoid inadvertent dosing with less than four hours of bedtime remaining, and inadvertent re-dosing in a single night. Based upon the content of the letter, it is possible that Transcept will need to conduct one or more additional safety studies. Transcept will request a meeting with the FDA to discuss specific requirements for approval. On 8/2/09, TSPT and privately-held Purdue Pharma announced an exclusive deal to commercialize Intermezzo (zolpidem tartrate sublingual tablet) in the U.S. Purdue will pay TSPT near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million based upon the timing of an FDA approval of Intermezzo, which approval and payment are subject to review and acceptance by Purdue.
On 10/29/09, Genta (OTC: GETA.OB) announced that the Phase 3 AGENDA clinical trial of Genasense (oblimersen sodium) Injection did not show a statistically significant benefit for its co-primary endpoint of progression-free survival. Secondary endpoints of overall response rate and disease control rate (which includes complete and partial responses, plus stable disease ≥ 3 months duration) also did not show a statistically significant benefit. 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). This is an example of conducting another pivotal Phase 3 trial based on data mining to identify a subset of patients who benefitted from a treatment in a previous study that failed to reach its primary, pre-defined endpoint(s). While there is nothing inherently wrong with the process of data mining and useful information can be generated; the risks are very high in conducting a new clinical trial based on this information since correlation does not equate with causation.
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