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Anavex Presents Preclinical Results of ANAVEX 2-73 in Rett Syndrome
- Data presentation at 2016 Epilepsy Pipeline Conference -
- Company exploring potential to advance ANAVEX 2-73 into human clinical studies
in rare disease indication -
New York, NY – February 25, 2016 – Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s Disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced positive data of ANAVEX 2-73 in an exploratory study in a Rett syndrome model at the 2016 Epilepsy Pipeline Conference being held February 25-26, 2016 in San Francisco, CA.
Chronic oral daily dosing of ANAVEX 2-73 starting at ~5.5 weeks of age was conducted in the MECP2 Rett syndrome disease mouse model and continued through a 12-week behavioral testing time point 60 minutes pre-treatment during the behavioral testing. Behavioral paradigms measure different aspects of muscular coordination, balance, motor learning and muscular strengths, some of the core deficits observed in Rett syndrome. The experiment was sponsored by the Rettsyndrome.org Scout Program and performed by PsychoGenics, Inc., NY.
“The data demonstrates dose related and significant improvements in an array of behavioral and gait paradigms in a mouse model with a MECP2-null mutation that causes neurological symptoms that mimic Rett syndrome. There is a tremendous need for therapeutic solutions for the individuals living with Rett syndrome and their families, and we are very encouraged by the data we have seen with ANAVEX 2-73,” said Steven Kaminsky, PhD, Chief Science Officer of Rettsyndrome.org.
Rett syndrome is rare non-inherited genetic postnatal progressive neurodevelopmental disorder that occurs almost exclusively in girls and leads to severe impairments, affecting nearly every aspect of the child’s life: their ability to speak, walk, eat, and even breathe easily. The hallmark of Rett syndrome is near constant repetitive hand movements while awake. It is characterized by normal early growth and development (6 to 18 months) followed by a slowing of development, loss of purposeful use of the hands, distinctive hand movements, slowed brain and head growth, problems with walking, seizures, and intellectual disability. There is currently no cure for Rett syndrome and treatment of the disorder is symptomatic. Management of the symptoms is done through a multidisciplinary approach utilizing medication for motor difficulties, breathing irregularities, and control of seizures through anticonvulsant drugs. Rett syndrome is caused by mutations in the MECP2 gene and strikes all racial and ethnic groups and occurs worldwide in approximately 1 in every 10,000-15,000 live female births.
Leader of the Rett syndrome Natural History Study, Alan Percy, MD, stated: “Given the strong clinical safety data profile of ANAVEX 2-73, it would be encouraging to explore the compound in patients with Rett syndrome, which is a very vulnerable patient population that in addition to its neurodevelopmental symptoms also experience a significant number of seizures.”
The presentation titled “Assessment of ANAVEX 2-73 in a MECP2 Rett Syndrome Mouse Model” will be presented by Christopher U. Missling, PhD at the 2016 Epilepsy Pipeline Conference in San Francisco, CA at 4:25 p.m. PST February 26, 2016 in the oral session and will be available on the publications page of the Anavex website.
“The positive preclinical signal in Rett syndrome seems to support the upstream mechanism of action of ANAVEX 2-73 with the potential to target not only neurodegenerative diseases such as Alzheimer’s, but also neurodevelopmental rare diseases like Rett syndrome,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
About Rettsyndrome.org
Rettsyndrome.org is accelerating research for treatments and a cure for Rett syndrome. As the world’s leading private funder of Rett research, they have funded more than $35 million in peer-reviewed research grants and programs to date. They are a 501(c) 3 organization, earning Charity Navigator’s most prestigious 4-star rating. Rettsyndorme.org empowers families to make a difference. Visit www.rettsyndrome.org to learn more, or call (800) 818-7388 (RETT).
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently in a Phase 2a clinical trial for Alzheimer’s disease. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety 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 in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. 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
Investors:
Jenene Thomas
Jenene Thomas Communications, LLC
908- 938-1475
Email: JTC@jenenethomascommunications.com
Media:
Jules Abraham
JQA Partners, Inc.
917-885-7378
Email: jabraham@jqapartners.com
©2016 Anavex Life Sciences Corp. All Rights Reserved.
I hope you used some of that powder this morning,
Fletch : > )
It's that huge gap from just a few days ago,
Fletch
http://www.investopedia.com/terms/b/breakawaygap.asp
Hey basparks79,
I think it's unlikely a successful BP would try to hurt Anavex. A hedge fund very well could. I too am OK with legal shorting but not OK with price manipulation or naked shorting. It's very hard to prove naked shorting is going on, even though the trading looks like that's what's happening. Also too many small wash trades dropping price. So far, our price movements are similar to many other small biotech companies. May the recent bottom hold up,
Fletch
You may well be right that lots of shorts are still in this. I'd think the smart ones would have covered by now. Why short this when much easier targets are out there? Most shorts like gloomy weather and hope for bad news.........not my favorite kind of people,
Fletch
Hey streetcalledStraight,
I see a high on 11/17 of $3.99 and a low on 11/18 of $3.87 so no gap there. You should go buy the high and low for a day and not the open or close.
Lets get moving up............GO AVXL,
Fletch
What your saying makes sense. Just thought it might be wrong to pay someone to promote, especially the way it was disused here.
Thanks to whoever put my closed over the 50 day chart up on the header. The bad there is we have been dropping since it was posted.
Go AVXL,
Fletch
My thought on the SEC subpoena is to check out if the company was involved in any stock price promotion. There was a lot of discussion on the board about this but most thought a third party paid for a one day pump. The company denied paying but I'm sure a short cabal can and would pay, the higher the price, the more $ they make.......
Go AVXL,
Fletch
All shorts should be real ashamed IMHO....to defame a company trying to help humanity to deal with a devastating problem called Alzheimer's.....REALLY! You want to make a buck on this going lower?
REAL SICK,
Fletch
Hey WHcraftsman,
Just posted what I did to try to stop the competition between the companies......lets have both companies win.......and they will,
Fletch
our 3 plus Alzheimers......
Just to let some know......CTIX is my first bio love but found it near the highs just about a year ago......this past late spring AV*L showed up on my radar........I never sold any CTIX but did buy AV*L in June in the .30's........So I own both.......not trading between them at all and wishing we all make big bucks on both......
Best wishes,
Fletch
A question for the board:
Some news comes out and I wonder how the news will be taken?
1. You dump all shares as any news will be real bad?
2. Sell first and ask questions later?
3. Sell quick as anything negative may get me a lower price later?
4. Hold on and investigate this news?
5. I'm holding no matter what happens?
Which one fits you?.......seems like some sell too quickly or there are shares for sale that aren't really there,
Fletch
http://www.microcapdaily.com/bounce-time-for-cellceutix-corp-otcmktsctix/114391/
Bounce Time for Cellceutix Corp (OTCMKTS:CTIX)
BY CARRIE RIVERS ON DECEMBER 28, 2015 MICRO CAP INSIDER, STREET WATCH
Cellceutix Corp (OTCMKTS:CTIX) continues to see general decline since the pop it saw in November to highs near $2 a share after the Company announced the FDA granted Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the Company’s novel defensin-mimetic Brilacidin for the prevention of oral mucositis.
CTIX is one penny stock to watch; over the past 4 years CTIX rose from pennies to a high of $4.93 last December becoming one of the top traded stocks on the entire bb’s before repeated short attacks some featuring SA hit pieces decimated the share price to current levels.
Cellceutix Corp (OTCMKTS:CTIX) is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships.
Cellceutix has just been granted Fast Track Designation for Brilacidin-OM, an oral rinse formulation of the Company’s novel defensin-mimetic Brilacidin, for the prevention of oral mucositis. Oral mucositis, a common and often debilitating inflammation and ulceration that occurs in the mouth as a side-effect of certain cancer treatments, afflicts approximately 450,000 patients each year in the United States and can affect the course and outcome of cancer therapy. There are no FDA approved drugs for the prevention of oral mucositis.
Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations.
Cellceutix’s anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction.
It all comes back to Cellceutix chief scientific officer, Dr. Krishna Menon; the man is a real whiz; he played key roles in developing two blockbuster cancer drugs; Gemzar and Alimta for Eli Lilly & Co.(NYSE:LLY) back in the late 90’s.
For CTIX he developed Kevetrin which just received Orphan Drug Designation for the treatment of ovarian cancer.. Kevetrin is successful in regulating the p53 pathway that has long been the holy grail of cancer research and big pharma. Industry leaders spent hundreds of millions of dollars trying to achieve what Dr. Krishna Menon has achieved with Kevetrin.
As anyone in the industry knows, regulating the p53 pathway has long been the holy grail of cancer research and big pharma has spent hundreds of millions of dollars researching ways to achieve this with no success thus far. It seems Kevetrin(TM) has accomplished this; extensive preclinical research on Kevetrin shows the re-activation of p53 across a wide spectrum of cancer lines including colon, lung, breast and pancreatic cancers.
If testing is successful, Mr. Ehrlich says the market potential for Kevetrin in treating drug-resistant cancers is worth $5 billion a year. Other cancers could easily represent an additional $5 billion annually, he adds..
For more info on CTIX Please Subscribe below, also you should know we have Something Huge Coming
Earlier this month CTIX announced that based upon ongoing laboratory studies, the Company intends to use docetaxel for the combination therapy arm in the planned Phase 2 clinical trial to treat patients with platinum-resistance ovarian cancer. Cellceutix is designing the multi-arm study to evaluate Kevetrin as a monotherapy and as a component of combination therapy.
In planning the combination therapy arm of the study, several different chemotherapies were tested with Kevetrin. Nude mice were implanted with a human ovarian cancer tumor. After tumors were established, mice were treated with 200 mg/kg of Kevetrin in combination with docetaxel at 15 or 30 mg/kg. Interim findings showed that mice treated with Kevetrin in combination with 15 mg/kg docetaxel exhibited a significant reduction in tumor growth. Kevetrin in combination with 30 mg/kg docetaxel further reduced tumor burden.
In November the FDA granted Fast Track Designation for the Company’s lead drug candidate Brilacidin-OM. According to the release ”In an ongoing Phase 2 trial, Brilacidin-OM is being evaluated for its safety and efficacy in preventing oral mucositis in patients undergoing chemoradiation for the treatment of head and neck cancer. Seven clinical sites and two satellite sites are currently enrolling patients in the trial, with additional sites expected to open enrollment in the coming weeks.”
On December 17 CTIX provided shareholders a re-cap of the Company’s first Annual Meeting of Stockholders, held Tuesday, December 15, 2015 at the office building of Cellceutix’s corporate headquarters in Beverly, Massachusetts. Cellceutix would like to thank all of the shareholders that attended.
CEO Leo Ehrlich said “I was very pleased to see such a strong turnout of shareholders showing their support of our Company; it was a pleasure meeting face-to-face with everyone. There was a lot of dialogue about corporate development, our clinical pipeline and advancing the rest of our portfolio, but the one thing that really struck me was all of the comments about the enormous size of the 100 Cummings Center office building.
We have a Monster Pick Coming. Subscribe Right Now!
Currently trading at a $158 million market valuation CTIX has $10 million in the treasury, manageable debt and no revenues to date. The stock was the darling of the bb’s all the way to $4.93 share before the shorts took to to the woodshed decimated the share price to lows of $0.941. CTIX is the same exciting story it always has been with several drugs in advanced clinical trials sitting on drugs in development that could potentially turn the multi-billion dollar drug-resistant cancers market upside down. The Company also recently announced the FDA granted Fast Track Designation for the Company’s lead drug candidate Brilacidin-OM. We will be updating on CTIX when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with CTIX.
Merry Christmas......go Anavex,
Fletch
Merry Christmas,
Fletch
Hey XenaLives,
I trade very little now. I use both OBV and CMF to see positive $ flowing in. I might sell a little on a big spike or gap up. A little dip so far this morning.........of little concern,
Fletch
On Bigcharts I like on balance volume and money flow. That is why I was using the chaikin money flow. The Stockcharts OBV must be higher now from the way it's figured......BWDIK. BTW, you once told me you don't use charts,
Fletch
I agree......Missling is AOK by me.....and go AVXL,
Fletch