ICAD has been way more interesting this year than ASCO. Medivation posts results of the P2 extension study, in which patients from both arms were treated for six months on top of the previous twelve. While the benefit was maintained in the original treatment group, the extenders from the placebo group did not do as well. Overall, the amyloid plaque treatment theory has taken some blows as various drugs have failed or posted shaky data, while the tau/tangle approach may get fresh impetus. Probably a combo would be best, but we're not seeing any such trials for a good while. There was a post on the neurodegenerative thread concerning how incredibly fast the plaques form in mice -- basically in a day. Well before the onset of symptoms. So I believe that any drugs targeting amyloid plaques are not really doing much by that pathway -- if at all.
Anyhow, the Dimebon results noted here came after publication in Lancet of the P2, which had goosed the stock back into the high teens low twenties. Upon release of this news about the extension trial, the stock gave up a little. Note that in the P3 now underway, Dimebon will be given on top of standard of care, whereas the Russian P2 patients had no prior of concomitant treatment. I'd love to see the animal data on this . . .
>>Medivation Alzheimer's drug helps - if used early
Wed Jul 30, 2008 3:28pm EDT
By Julie Steenhuysen
CHICAGO, July 30 (Reuters) - A drug for Alzheimer's disease made by Medivation Inc. kept symptoms at bay for 18 months, U.S. researchers said on Wednesday, but people who got the drug after first taking a placebo fared less well, suggesting early treatment is best.
The latest results, being presented at the Alzheimer's Association's international meeting in Chicago, found Dimebon was safe and continued to benefit people who took it for a year and a half.
"The most important thing from my point of view is there were no new safety issues that emerged with longer exposure of the patients," said Dr. Jeffrey Cummings of UCLA, who helped with the study.
The results from the 183-patient study conducted in Russia found people continued to improve, with benefits seen in cognition, memory, activities of daily living and behavior.
The study also found that people who were treated with a placebo for a year and then took Dimebon stabilized across five measures of thinking ability, but were unable to catch up to the group who had taken it for the full 18 months.
"People initially treated with the placebo and then crossed over to Dimebon did not show the same level of benefit as those people who took Dimebon for the full 18 months," Cummings said in a statement.
"This emphasizes the benefit of earlier treatment and suggests the possibility that Dimebon may slow the progress of Alzheimer's," he said.
Medivation has provided frequent updates of patients in the study in Russia, where patients in the study took few if any drugs other than Dimebon.
Such a study would not be possible in Western countries, where most Alzheimer's patients take a variety of other drugs.
Some doctors think the true test of whether Dimebon represents an advance over current therapies will come from studies done in the West, where patients have ready access to other drugs that can slow progression of the disease.
These include Eisai Co Ltd's (4523.T: Quote, Profile, Research, Stock Buzz) and Pfizer Inc's (PFE.N: Quote, Profile, Research, Stock Buzz) Aricept, Forest Laboratories Inc's (FRX.N: Quote, Profile, Research, Stock Buzz) Namenda, Novartis AG's (NOVN.VX: Quote, Profile, Research, Stock Buzz) Exelon and Johnson & Johnson's (JNJ.N: Quote, Profile, Research, Stock Buzz) Razadyne.
All affect message-carrying chemicals in the brain called neurotransmitters, but lose their effect over time.
"The one issue with this trial is that no other treatments were allowed," Dr. Scott Turner, incoming director of the Memory Disorders Program at Georgetown University Medical Center in Washington, said in a telephone interview.
"Here it will be tested as an add-on, and the question is will it have any other benefit (when taken) with the current therapies," he said. "I think that is a big if."
Cummings thinks the drug has a shot.
"I think we will continue to see an effect because the signal was strong; but under the circumstances of a global trial, it will likely be not as clearly seen as it was in the Russian trial," he said in a telephone interview.
In late afternoon Nasdaq trading, Medivation shares were down 84 cents or 4.3 percent to $18.93.<<
Another question relative to MDVN regards the prostate cancer drug, which looked interesting to me a while back, and was a contributing factor in keeping me from shorting MDVN again. Now, with more data out on it, some biofreaks think this is one of the more promising molecules for the indication. My inclination is to let the Dimebon story play out and watch the data from 3100, too. If 3100 gets shot down early for some reason, I'd probably short based on my continued bearish view of Dimebon. If Dimebon gets shot down first, I'd consider going long. For now, just watching, and looking elsewhere for shorts.
Cheers, Tuck |
