Friday, January 26, 2018 10:57:13 PM
Xena, IMHO the ACTC is driving the forward progress of the Anavex 2-73 P2/3 trial. As the potential Alzheimer's drugs continues to dwindle with Lily, Pfizer, Takeda and others dropping out of contention and Biogen continues to run their own large P3 of Aducanumab, 2-73's possibility as a ACTC candidate increases. That's based on 2-73's positive P2, its multiple disease application and the significant data analysis conducted so far. That means money, infrastructure and a large body of FDA/NIH/CDER support to accelerate the trial's accomplishment. However, it also means that Anavex has to proceed on the NIH/ACTC time frame and that that it will be the Government that announces the trials start.
If the aforementioned premise in valid, then it would explain to the absence of any partnership talk to date. In fact it would complicate any such discussions if the Government was moving 2-73 forward.
It is good to refresh the board memory of the NIH's announcement on the ACTC:
"A new clinical trials consortium funded by the National Institutes of Health is expected to accelerate and expand studies for therapies in Alzheimer’s disease and related dementias. The infrastructure of 35 sites across the United States – called the Alzheimer’s Clinical Trial Consortium (ACTC) – will address the timeframe, complexity and expense of the recruitment process and site activation for Alzheimer’s trials to find new and effective ways to treat or prevent these devastating disorders.
The ACTC will be led jointly by research teams from the University of Southern California Alzheimer’s Therapeutic Research Institute (ATRI), San Diego, Harvard-affiliated Brigham and Women’s Hospital and Massachusetts General Hospital, Boston, and Mayo Clinic, Rochester, Minnesota. The funds were awarded by the National Institute on Aging (NIA) at NIH, which leads the federal effort in Alzheimer’s research. NIA will also provide scientific input to the ACTC under the cooperative agreement
The award for support of the consortium is expected to total nearly $70 million over five years, pending the availability of funds. Specific trials would be funded separately, under a process by which investigators can team up with the consortium to undertake research. Funding opportunity announcements for specific ACTC trials are expected to be released in early 2018 and will be open to all qualified investigators. It is anticipated that the ACTC will have the capacity to handle five to seven trials during the five-year award period."
https://www.nia.nih.gov/news/new-nih-consortium-award-enhance-clinical-trials-alzheimers-disease-related-dementias
If the aforementioned premise in valid, then it would explain to the absence of any partnership talk to date. In fact it would complicate any such discussions if the Government was moving 2-73 forward.
It is good to refresh the board memory of the NIH's announcement on the ACTC:
"A new clinical trials consortium funded by the National Institutes of Health is expected to accelerate and expand studies for therapies in Alzheimer’s disease and related dementias. The infrastructure of 35 sites across the United States – called the Alzheimer’s Clinical Trial Consortium (ACTC) – will address the timeframe, complexity and expense of the recruitment process and site activation for Alzheimer’s trials to find new and effective ways to treat or prevent these devastating disorders.
The ACTC will be led jointly by research teams from the University of Southern California Alzheimer’s Therapeutic Research Institute (ATRI), San Diego, Harvard-affiliated Brigham and Women’s Hospital and Massachusetts General Hospital, Boston, and Mayo Clinic, Rochester, Minnesota. The funds were awarded by the National Institute on Aging (NIA) at NIH, which leads the federal effort in Alzheimer’s research. NIA will also provide scientific input to the ACTC under the cooperative agreement
The award for support of the consortium is expected to total nearly $70 million over five years, pending the availability of funds. Specific trials would be funded separately, under a process by which investigators can team up with the consortium to undertake research. Funding opportunity announcements for specific ACTC trials are expected to be released in early 2018 and will be open to all qualified investigators. It is anticipated that the ACTC will have the capacity to handle five to seven trials during the five-year award period."
https://www.nia.nih.gov/news/new-nih-consortium-award-enhance-clinical-trials-alzheimers-disease-related-dementias
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