Replies to post #145617 on Biotech Values

[DewDiligence]

Gammagard addendum: BAX rose only 1.7% today because: i) there remains a high degree of skepticism about the pending phase-3 trials; and ii) it’s unclear how profitable Gammagard for AD would be for BAX due to the high manufacturing cost and the weak IP.

[masterlongevity]

i don't trust 4 pts worth of data. 25-35% of patients in AD trials do not actually have AD, and some may get better for other reasons.

I hope this works, but am skeptical

[iwfal]

BAX IVIG Gammagard Alzheimer's

Patients who were switched to a variety of doses of the medication after initially getting a placebo continued to decline, an unexpected finding, Relkin said. After a year of therapy, all were switched to the intermediate dose and stabilized, showing the dose of the medication is critical, he said.

A U-shaped dose response would, to me, imply substantially less credibility than the absolute numbers imply. And even if true that it has a U-shaped dose response it will make it much harder to get it right in ph iii.

[jq1234]

EnVivo Pharmaceuticals Announces Statistically Significant Improvement in Cognition and Clinical Function in Phase 2b Clinical Trial in Alzheimer’s Disease
07/18/2012


WATERTOWN, Mass. – July 18, 2012 - EnVivo Pharmaceuticals, a company dedicated to developing a broad range of novel central nervous system (CNS) therapies, today announced positive results from its Phase 2b clinical trial of EVP-6124, a novel alpha-7 agonist, in patients with Alzheimer’s disease during an oral presentation at the Alzheimer's Association International Conference 2012 (AAIC) being held in Vancouver, British Columbia. The six-month, double-blind Phase 2b clinical trial evaluated EVP-6124 against placebo in patients with mild to moderate Alzheimer’s disease. The EVP-6124 2.0 mg dose met both of the trial’s primary endpoints with statistically significant positive effects on cognition (p=0.0189), as measured by the Alzheimer's Disease Assessment Scale-Cognitive subscale-13 (ADAS-Cog-13) and clinical function (p=0.0253) as measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). The data also showed statistically significant results across secondary endpoints of other cognitive and clinical measures. Importantly, EVP-6124 was generally safe and well-tolerated over the trial’s six-month dosing period. Based on the Phase 2b trial results, EnVivo will continue to advance EVP-6124 and plans to initiate a Phase 3 clinical trial in Alzheimer’s disease in 2013.

http://www.envivopharma.com/news-item.php?id=40

[ghmm]

BAX / AD Results:

They announced in the call the DB is locked and are going through the data. Expect results to be PR'd in Q2 still and then presented in July I believe they said. Some data on mild vs. moderate will be released (said some other data about subsets too but didn't catch)

The second trial is scheduled to complete enrollment end of year (I believe said about half enrolled now) and 18 month treatment so 2015 results.