A well written article, AF should read it closely.
Emphasis mine..
Urgent need for Alzheimer’s research funding E. Teresa Touey 11:02 p.m. CST January 21, 2016 Teresa Touey
(Photo: Submitted)
The Dementia Discovery Fund is a recently created $100 million global fund to assist small biotechs and entrepreneurial ventures in finding a treatment or cure for Alzheimer’s. The fund is sponsored by the British government, the charity Alzheimer’s Research UK, Johnson and Johnson, Eli Lilly & Co., Pfizer, Biogen Idec and GSK.
“This fund is great news; however, funding for Alzheimer’s is still much lower compared to cancer funding,” said Christopher U. Missling, Ph.D., president and CEO of Anavex Life Sciences Corp., a publicly traded biopharmaceutical company headquartered in New York City.
Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, a combination of ANAVEX 2-73 and donepezil (marketed under the trade name Aricept), are in a Phase 2a clinical trial for Alzheimer’s. The ongoing, multicenter Phase 2a clinical trial in Melbourne, Australia, started in January 2015, with The Alfred Hospital as the lead site.
To support its operations and advance its clinical trial work, Anavex has secured key funding commitments and had approximately $15.3 million in cash and cash equivalents as of Sept. 30. The company also has filed a $100 million shelf financing and entered into a purchase agreement with Lincoln Park Capital to sell an aggregate of $50 million worth of shares. Anavex previously reported that it is fully funded through completion of the current Phase 2a clinical trial.
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild to moderate Alzheimer’s patients. Part A is a simple randomized, open-label, two-period adaptive trial, crossing over between oral (30mg/50mg) and IV (3mg/5mg) administration, lasting up to five weeks for each patient. Part B is an open-label extension for an additional 52 weeks. Initially planned for 26 weeks, Part B, which is now underway, was extended to 52 weeks as a result of requests from patients and caregivers.
Encouraged by its findings, the company looks to advance ANAVEX 2-73 into a larger Phase 2/3 study for Alzheimer’s. It also hopes to initiate a double-blinded, randomized, placebo-controlled Phase 2 trial for ANAVEX 2-73 in an additional indication associated with cognitive impairment.
In July, Reps. Fred Upton, a Michigan Republican, and Diana DeGette, a Colorado Democrat, led passage of the 21st Century Cures Act by a 344-77 vote. Norm Ornstein wrote in The Atlantic, “The act does many things, including making research collaborations easier; promoting therapies like biomarkers to enhance personalized drug treatments, targeted at individuals and not just broadly at diseases; reforming and streamlining clinical trials and making it less challenging and expensive for companies to bring drugs to market; creating incentives for developing drugs for uncommon but deadly diseases; creating an Innovation Fund to encourage young scientists to do path-breaking research; and putting more money into both the National Institutes of Health and the Food and Drug Administration to make these innovations work.” The bill may impact the mathematics of Alzheimer’s funding. As previously reported by the Alzheimer’s Association, for every $27,000 Medicare and Medicaid spends on caring for individuals with Alzheimer’s, the NIH spends only $100 on Alzheimer’s research. Further, Medicare’s annual expenditures are projected to triple from $300 billion currently to $1.5 trillion by 2050 if no cure for Alzheimer’s is found. Missling said the caretaking costs could put Medicare in a precarious place financially, even possibly bankrupting it.
In early December, an increase of nearly 60 percent for Alzheimer’s research was passed by the U.S. Congress in the federal spending bill, expanding funding from $586 million in 2015 to $936 million in 2016.
The next steps with the potential for impact for Alzheimer’s will happen at the U.S. Senate Committee on Health, Education, Labor and Pensions. Respectfully, I urge Chairman Lamar Alexander to pass this bill in the committee, which he co-leads with ranking member Patty Murray. It will take 22 senators to deliberate to find common ground by giving and taking and incorporating key ideas. Patients and their families know the urgency. Those afflicted regularly confuse past and present memories. Unleashing this act’s potential could capture lost time.
E. Teresa Touey is the editor and publisher of Spotlight on Bio Advances, a blog that showcases the stakeholders in the life sciences sector of the mid-Atlantic states.
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