No irons in the fire with GNTA, but whether or not Genasense works/gets approved, I doubt that it is a scam. AVE is too close to this, and has too much at stake. They would have smelled a scam long ago.
It seems that between them and ALTH, they have scared people out of cancer stocks. Both CTIC and DNDN, which have little to do with Genta, are down in sympathy.
[ALTH] The “new” FDA may not be as new as some investors believed:
[When the FDA approved Iressa, Velcade, and Erbitux under the “Accelerated Approval” program following the appointment of Mark McClellan, many investors took it to mean that the agency had taken on a kindler, gentler comportment that would greatly change the dynamics of drug approvals. Yesterday, however, the FDA appeared to be drawing a line in the sand to say that companies such as Genta and Allos should not expect to win approval with substandard data packages. Perhaps the three successive accelerated approvals (Iressa, Velcade, Erbitux) may have been merely the “Poisson distribution” at work again (#msg-2486205). Commiserations to ALTH holders.]
>> FDA staffers say Allos drug benefit unconvincing
Friday April 30, 4:45 pm ET By Jed Seltzer
NEW YORK, April 30 (Reuters) - U.S. regulatory reviewers on Friday said they were not convinced that Allos Therapeutics Inc.'s (NasdaqNM:ALTH) experimental therapy benefited patients with tumors that had spread to the brain from the breast, sending Allos shares tumbling as much as 52 percent.
Allos last year said the therapy did not significantly improve upon radiation therapy among all patients tested with brain cancer but helped a sub-group of patients whose brain tumors came from breast cancer that had spread.
One FDA reviewer called the latter finding "exploratory," in part because the sub-group was not specified before the trial started. Reviewers from the U.S. Food And Drug Administration said the company's claims were "not convincing."
The reviewers' finding came in documents released on Friday by the U.S. Food and Drug Administration ahead of an advisory panel review on Monday.
In the 538-patient Phase III clinical trial, Allos compared brain radiation therapy to a combination of radiation and the company's treatment, called RSR13.
The treatment is designed to increase the availability of oxygen in the brain. Oxygen fosters an environment in which radiation therapy is effective, so a shortage of oxygen can reduce the effectiveness of radiation.
According to the FDA documents, the median survival among patients on the combination treatment was 5.3 months compared with 4.5 months on the radiation. But the margin was slightly wider for patients whose brain tumors had spread from the breast, 5.9 months versus 4.5 months. However, neither difference was statistically significant.
FDA reviewers in analyzing the results cited a section of the government guidelines about using sub-groups to declare a clinical trial successful.[The following passage should be committed to memory by biotech investors –Dew] "These analyses are not intended to 'salvage' an otherwise non-supportive study but may suggest hypotheses worth examining in other studies or be helpful in refining labeling information, patient selection, dose selection, etc," the reviewers said in the documents, quoting the regulations.
The main statistical reviewer that prepared and reviewed documents for the FDA panel on the Allos treatment concluded that the benefit observed among the subgroup could be attributable to other factors.
"The evidence of drug efficacy needs to be much stronger to be convincing," the reviewer wrote.
FDA advisory panels include experts in the therapeutic area for which the treatment at issue is intended, and the agency usually takes the advice of its panels.
Shares of Allos slumped $2.09, or 45 percent, to close at $2.55 on the Nasdaq, where it was the top percentage loser. The stock traded as low as $2.21 during the day.
Allos said on Friday afternoon it would hold a conference call to discuss the results of the panel meeting on Monday afternoon. <<
A US Food and Drug Administration advisory panel on Monday rejected an application from Genta and Aventis for the experimental cancer drug Genasense, demonstrating that the agency has not loosened its requirements to the extent some had hoped.
A request for approval for the treatment, designed to treat a deadly type of skin cancer, was controversial. “I think it would have been strange for the FDA to clear the drug, based on the quality of the information Genta submitted,” said Viren Mehta of Mehta Partners, the pharmaceutical analysis firm. “They chose not to disclose data from two other trials of the drug, even though the studies were complete. That's very unusual.”
Genta argued that the condition of patients taking Genasense appeared to deteriorate more slowly. The FDA, however, said the data were unclear, and that much of the improvement noted may have been due to chance.
An easing of requirements by the agency during the past two years had raised hopes that Genasense might be cleared. The FDA had become particularly amenable to new products for diseases with few treatment options, including many types of cancer.
Two years ago, obtaining the go-ahead from the FDA meant showing improved survival rates for cancer patients. The approval of AstraZeneca's Iressa in late 2002, however, signaled a shift in the approval process. Instead of extended survival, the FDA argued it could clear cancer drugs based on other factors, such as tumour shrinkage. The looser approach later led the agency to give the green light to the controversial colon cancer drug Erbitux, made by ImClone. Genasense was key for Genta, but also important for Aventis, which had cut a $480m dollar deal for rights to the compound. <<
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