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Anavex Completes Patient Enrollment for Phase 2a Alzheimer’s Trial Ahead of Schedule
New York, NY – September 28, 2015 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (OTCQX: AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer, today announced that patient enrollment for the Phase 2a clinical trial of ANAVEX 2-73 has been completed ahead of schedule. With the Phase 2a trial now fully enrolled, Anavex expects to release topline data for PART A before the end of the year.
“There has been significant interest in our Phase 2a Alzheimer’s trial and full enrollment is an important step forward. We are delighted to be ahead of schedule and thank the patients and their families for their participation,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We look forward to the full ANAVEX 2-73 Phase 2a trial results and our team is excited to continue moving this clinical program forward.”
ANAVEX 2-73 is the investigational drug in the Phase 2a trial and is the Company’s lead investigational oral treatment for Alzheimer’s. It targets sigma-1 and muscarinic receptors, which is believed through upstream action to reduce protein misfolding, beta amyloid, tau and inflammation.
About the ANAVEX 2-73 Phase 2a Study
The ongoing, multicenter Phase 2a adaptive trial of ANAVEX 2-73 in both male and female mild-to-moderate Alzheimer’s patients has enrolled 32 patients. It started in January 2015 and all the 32 patients, most who are also taking donepezil, have initiated PART A of the two-part trial.
Lasting up to 36 days for each patient, PART A is a simple randomized, open-label, two-period trial with an on-off-on not-yet-optimized dosing regimen to assess bioavailability, and cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration. Event-related potentials (EEG/ERP) are used to assess cognitive effects and optimize dosing of ANAVEX 2-73. PART B is an open-label extension for an additional 52 weeks, with daily oral dosing so as to establish a longer drug effect.
The primary endpoint of the Phase 2a trial is evaluation of the maximum tolerated dose of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints are dose response, bioavailability, exploratory cognitive effects using electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), Mini Mental State Examination (MMSE), Cogstate and evaluation of ADSC-ADL and add-on therapy to donepezil, the current standard of care, which represents ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®).
Additional information regarding the trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About Alzheimer’s Disease
Today, Alzheimer’s disease remains the largest unmet medical need in neurology. More than 25 million people are currently diagnosed with Alzheimer’s, with the associated cost of care estimated to exceed $200 billion annually. By 2050, 100 million people are expected to be living with the disease. Alzheimer’s disease is a neurological disorder generally characterized by memory loss and cognitive decline. A neurodegenerative form of dementia, the disease begins with mild symptoms and becomes progressively worse.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (OTCQX: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. Initial positive data was presented at AAIC 2015 and full PART A data is expected by year end. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties indicating its potential to treat additional CNS disorders. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Gross margin is a joke. Gross margin? lol
Did I hear there is a pot meeting in New Jersey?
Does TRTC sell oregano?
What about the hash industry?
How much are doobie papers?
Where does trtc grow pot?
When does the TRTC doobie truck make deliveries? Anyone know?
Need for money is greater than net profit. Has nothing to do with catalyst or prs. It's called arithmetic.
Major pps plunge coming today. Sorry.
What are they going to sell, pot from the CEO? TRTC should have had a crop and a half by now. Despicable.
How do you know. Through social media? lol
TRTC is frantically and desperately trying to raise cash. Look out below. You've been warned.
I might buy 1000 shares at .02, but even then, I will have to consider more downside. It won't be long either.
One day 40,000,000 shares are going to pass. TRTC needs a lot of money in a short period of time. No rocket science required.
Just like I said, CDEL is on the Ask. I am so great.
192
We'll see I guess. It starts on the 29th. See you there.
What type of glue does TRTC use on their doobie papers, or are they glueless?
Does TRTC change the oil in their a pot delivery truck regularly, or do they forget to do that? Anyone?
Who knows? It could be a private agreement imbedded in the creation of Medifarm 3. Wouldn't that be a kick in the balls?
They already have Medifarm, Medifarm 1, and Medifarm 2; of which TRTC only owns 55%.
When does TRTC start making doobie papers?
When TRTC directors meet to discuss business, do they buy pizza?
How much does it cost to install ready made cash registers in a dispensary?
How often does it happen that the TRTC delivery truck gets new tires?
100%.
How about the time when pot seeds were for sale?
When is the next pot meeting regarding Colorado. Does TRTC own marijuana?
I still think the marijuana and garlic would be a good combo.
LOL dude.
Terra tech will build and equip the building, then insiders will rent it from TRTC, right?
I did not see or read any filings pertaining to this. Can you post them for me? How can you read them if they are not published yet?
About those accredited investors, where are those filings? Do you know? TRTC said in a press release that they would be filed by August in Q2 or a new filing.
I've heard such great things from and about the company. I've made quite a bit of cash on this, but I can't find the filings, which is important to me as an investor. Do you know where they are?
Are you interested in the filings. Wouldn't you like to read them? Who would not want to read filing that are promised to shareholders? If they don't file them, at least TRTC could issue a press release saying they will not do it. It's no biggy if they don't if they are in compliance, but we were informed to expect them.
It is not bs. Shareholders and prospective shareholders need to know this information. The original Dominion agreement has never seen the light of day. There was a 8K filing and an 8KA, but the CT order holds more information.
I think TRTC has to file it according to the CT order, don't you? Or how about the recent cash raise? TRTC said they would file 2 exhibits or a registration statement. Wouldn't you like to know? If not, why not? Thanks.
About those missing SEC filings. Anyone find them yet? I've looked everywhere. If they are not going to file them, one would think they would notify investors for the reason why. TRTC said they would and/or the SEC allowed confidentially until December 2014. Anyone know anything?
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Exhibit 10.12 is missing from this CT order. Contained in it, is the original Dominion agreement. It dates back to the Hanover registration statement. Dominion never had an original registration statement. It is hidden in the CT order I presume. The public, including me, does not know what is contained in it. It was to have been filed in December 2014.
http://www.sec.gov/Archives/edgar/data/1451512/999999999714000635/filename1.pdf
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These filings are missing from the recent capital raise in June:
Exhibit 10.26, and Exhibit 4.6, or a registration statement for the private placement.
http://biz.yahoo.com/e/150612/trtc8-k.html
"The description of certain terms and conditions of the Form of the Subscription Agreement and Form of Warrant set forth herein do not purport to be complete and are qualified in their entirety by the full texts of the Form of Subscription Agreement and Form of Warrant, which will be filed as Exhibit 10.26, and Exhibit 4.6, respectively, to the next quarterly report or registration statement we file with the Securities and Exchange Commission."
The sec required the filing by December 2014.
About those missing SEC filings. Anyone find them yet? I've looked everywhere.
*********************************************************************
Exhibit 10.12 is missing from this CT order. Contained in it, is the original Dominion agreement. It dates back to the Hanover registration statement. Dominion never had an original registration statement. It is hidden in the CT order I presume. The public, including me, does not know what is contained in it. It was to have been filed in December 2014.
http://www.sec.gov/Archives/edgar/data/1451512/999999999714000635/filename1.pdf
*********************************************************************
These filings are missing from the recent capital raise in June:
Exhibit 10.26, and Exhibit 4.6, or a registration statement for the private placement.
http://biz.yahoo.com/e/150612/trtc8-k.html
"The description of certain terms and conditions of the Form of the Subscription Agreement and Form of Warrant set forth herein do not purport to be complete and are qualified in their entirety by the full texts of the Form of Subscription Agreement and Form of Warrant, which will be filed as Exhibit 10.26, and Exhibit 4.6, respectively, to the next quarterly report or registration statement we file with the Securities and Exchange Commission."
Maybe this will help:
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Exhibit 10.12 is missing from this CT order. Contained in it, is the original Dominion agreement. It dates back to the Hanover registration statement. Dominion never had an original registration statement. It is hidden in the CT order I presume. The public, including me, does not know what is contained in it. It was to have been filed in December 2014.
http://www.sec.gov/Archives/edgar/data/1451512/999999999714000635/filename1.pdf
*********************************************************************
These filings are missing from the recent capital raise in June:
Exhibit 10.26, and Exhibit 4.6, or a registration statement for the private placement.
http://biz.yahoo.com/e/150612/trtc8-k.html
"The description of certain terms and conditions of the Form of the Subscription Agreement and Form of Warrant set forth herein do not purport to be complete and are qualified in their entirety by the full texts of the Form of Subscription Agreement and Form of Warrant, which will be filed as Exhibit 10.26, and Exhibit 4.6, respectively, to the next quarterly report or registration statement we file with the Securities and Exchange Commission."
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