Considering the current phase II runs until the end of the year and according to their website, a larger phase II is planned. The earliest a phase III trial would start would be late 2016.
"Anavex initiated a Phase 2a trial with ANAVEX 2-73 and ANAVEX PLUS in Q4 2014.
Thereafter, the Company plans to initiate a potentially pivotal six-month Phase 2 trial with ANAVEX PLUS. This trial is expected to include up to 300 mild-to-moderate Alzheimer’s patients."
They (the company) should have been clearer on their website that this is not the ANAVEX PLUS trial.
Frm thei website:
Anavex initiated a Phase 2a trial with ANAVEX 2-73 and ANAVEX PLUS in Q4 2014.
Thereafter, the Company plans to initiate a potentially pivotal six-month Phase 2 trial with ANAVEX PLUS. This trial is expected to include up to 300 mild-to-moderate Alzheimer’s patients.
Clinical trials are conducted by third-party organizations, not by Anavex directly. Trial participants are selected independently of the company to avoid undue influence.
Note: Individuals seeking information about participating in a clinical trial should contact his/her doctor.
Anavex has filed a patent application for the ANAVEX PLUS combination of donepezil (Aricept®) and ANAVEX 2-73. If granted, patent protection for ANAVEX PLUS will be in place until at least 2033.
I apologize. From what I been reading Anavex Plus will be one pill that combines the Anavex 2-73 with Donepezil.
In this trial most of the patients (who are already taking Donepezil) were given Anavex 2-73 separately. So, this is not the combo trial (Anavex Plus) where patients would take one pill.
However, since most patients are already taking Donepezil, one cannot state that the results reflect Anavex 2-73 as a monotherapy.
Gizmo, you keep on bringing up that it's not the combo.
You're wrong. The poster clearly states that most of the evaluated patients are on Donepezil.
The company schedule had primary outcome results due out in Q3. They have now changed that to EOY.
Results are very preliminary (1 month) and sample size is small so I'm not overly excited.
Interim data would be nice.
Prof Macfarlane said while it was important to recognise the positive results of the trial, they were only preliminary and most of the drugs currently in development were unlikely to be a cure for Alzheimer’s disease.
You either conveniently forgot to post the rest of the article or yahoo wouldn't let you post it all.
Either way, important to see the lead investigator cautious comments.
This is not Anavex 2-73 monotherapy. Go to their website and call up the poster. The data is from 12 patients mostly on Donepezil.
Also, they aren't on schedule.
“We are cautiously optimistic given the encouraging feedback and the preliminary cognitive data. We look forward to the full ANAVEX 2-73 Phase 2a trial results,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “As of today, we have enrolled two-thirds of the patients. We expect the trial to be fully enrolled and to have PART A completed by the end of the year.”
Now, now, don't be mean. You're going to get a bunch of red thumbs.
Remember the Epilepsy indication only is worth billions even though it's still in the preclinical phase.
As Ralph Kramden used to say "to the moon".
From a recent Reuters article: (part 1)
A vast majority of Americans say the Medicare health program for the elderly should be able to negotiate with drug companies to set lower medication prices, a practice currently prohibited by law, according to a survey released on Friday.
The poll conducted by the Kaiser Family Foundation found that 87 percent of people surveyed want Medicare to have the authority to press drugmakers for greater discounts. The skyrocketing prices for crucial medicines have hit both health insurers and consumers, who are being asked to cover a higher proportion of their medications' cost.
"People don't understand why these drugs cost so much, and they don't understand why, in America, you can't negotiate for a better price," said Mollyann Brodie, executive director of public opinion and survey research at Kaiser Family Foundation.
Efforts to allow Medicare to negotiate drug prices have not been successful, due to opposition over government interference in the marketplace. Drug manufacturers say their prices reflect the billions of dollars they spend in research and development, both for treatments that are approved and the many more that fail.
Previous Kaiser polls underlined other frustrations over drug costs. A top priority for Americans in April was making drugs affordable for people with chronic conditions like diabetes.
In a June poll,73 percent of participants thought prescription drug prices were unreasonable. Over three-quarters of those people said it was because manufacturers set prices too high.
Public dissatisfaction has been on the rise since a controversy last year over Gilead Sciences Inc's novel hepatitis C cure. The drug, Sovaldi, came with a list price of over $80,000, or $1,000 for a single pill.
Final data collection for primary outcome (maximum tolerated dose) is due in September according to the info on clinicaltrials.gov.