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It looks like pros bought shares weeks ago and sold a bunch of them to index funds yesterday -
Even if you have the capability to plunge into this trade, you missed your chance. The pros were making their bets more than a month ago. That’s because May 31 is the cutoff date for how the Russell indices will be rebalanced. All bets were placed weeks ago. Indeed, historically speaking, trading on the reconstitution of the Russell 2000 earns most of its money in the middle of May, according to research from Credit Suisse.
http://investorplace.com/2013/06/too-late-to-trade-the-russell-2000-rebalance/
The PR on August 12, 2015 revealing the Notice of Allowance for U.S. patent application related to A2-73 stated this (bold by me)-
The allowed patent claims cover formulations and treatments that provide particular coverage relating to improved sigma receptor ligands and their use.
“This patent is a valuable addition to our IP portfolio and covers innovations we have made in our development efforts for ANAVEX 2-73 and beyond,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “We have filed numerous patent applications to cover promising compositions and therapies, including those pertaining to ANAVEX 2-73, in keeping with our commitment to a comprehensive IP protection strategy.”
Additional U.S. patent applications filed for pharmaceutical composition of matter for ANAVEX 2-73 will, if granted, provide further patent protection until at least 2035. An additional patent application on file for ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil, if granted, will provide protection for composition of matter until at least 2033.
Wouldn't it be likely that Anavex has filed an updated A2-73 patent application covering Alzheimer's based on "improved sigma receptor ligands and their use" and "innovations we have made in our development efforts for ANAVEX 2-73".
We will be seeing more patent applications in the coming months. This from IR in the beginning of May, 2016 -
Thank you for your email and interest in Anavex Life Sciences Corp. (Nasdaq: AVXL).
The latest press release issued regard a patent related to ANAVEX 2-73 was issued on August 12, 2015. You may view it here: www.anavex.com/?news=anavex-receives-notice-of-allowance-for-u-s-patent-application-related-to-anavex-2-73.
Anavex is extremely focused on the patent position of ANAVEX 2-73 and related drugs. The company is engaged in a rigorous patent filing and prosecution effort to protect Anavex in all forms, methods of use, and methods of production. Patent applications are necessarily published 18 months from filing. When published, the investor community will be free to review these patent applications. At such time, the investor community will be able to evaluate the scope of patent protection sought and granted.
Patents enjoy a minimum term of 20 years from the earliest claimed filing date. For various reasons, this term may be extended for up to five years by the Patent Office.
Please do not hesitate to contact our office if we can be of further assistance.
On behalf of Anavex Life Sciences Corp.,
Investor Relations
Toll Free (North America): 1 (866) 505-2895
Outside North America: +1 (416) 489 0092
Fax: +1 (416) 352 5239
ir@anavex.com
That was the author's share price target in August, 2015. That was before the full top line 5 week data was released in November, 2015.
From pre-split August, 2015 article -
In AD alone, AVXL has a fair value of $5 per share, after adjusting for risk. If you add the potential in Parkinson's, then the potential value of the stock is even higher. If AVXL's concept is proven in AD, it is very likely that it will be proven in Parkinson's as well.
http://seekingalpha.com/article/3444196-premarket-biotech-digest-axovant-analysis-anavex-gets-grant-pharmacyclis-imbruvica?auth_param=btpbb:1at3j0l:afa85ef47d3b60d78c9840325c93132b&uprof=45
The SEC doesn't decide when data is ready to be released by a company. The company decides that. Can you imagine the SEC telling a company that they can't analyze data before releasing it to the public. I can't.
Data is made public when a company decides that it is ready to be made public.
I see the circles (doses) now. Thank You.
http://www.anavex.com/files/2016-03-12_AAT_Anavex_Presentation_2016.pdf
Great Post!
I loved the reversals shown on this slide -
https://pbs.twimg.com/media/CTMsjZYWcAAZ6J5.jpg:large
Anavex has not given us the info on how they arrived at 14mg. It's not from preclinical data.
The slide does tell us that the doses were 3mg & 5 mg IV, and 30mg & 50 mg oral.
I think they only dosed at 3&5 IV and 30&50 oral. There has been no other dose information that I have seen.
Why would you state this -
"Hence the Part A dose dependency title as a placeholder."
When the AAIC states this -
"If you are interested in having the research you present at AAIC eligible for inclusion in AAIC news releases and news conferences, it must not be published (online or hard copy) or presented, in whole or in part, in any manner, previous to the presentation at AAIC."
A minimum dose of 14 mg ANAVEX 2-73 required to achieve a therapeutic effect and to keep MMSE score unchanged
ANAVEX 2-73 starting dose 30mg/50mg (oral) or 3mg, 5mg (IV)
ANAVEX 2-73 starting dose 30mg/50mg (oral) or 3mg, 5mg (IV) + Donepezil
http://www.anavex.com/files/Anavex_Presentation_Spring_2016.pdf
I wouldn't state this as fact -
No way Anavex presents previously disclosed info at AAIC. Premier conferences don't allow it. An example from ASCO -
CHICAGO – A presentation at the annual meeting of the American Society of Clinical Oncology by Immunomedics (IMMU) has been rejected after it was discovered the company was trying to use old and previously presented data for its triple negative breast cancer drug IMMU-132, thestreet reported this morning.
Presenting old data as new is against the rules of ASCO, thestreet’s Adam Feuerstein reported. The presentation, which can currently be found on Immunomedics’ website, was previously presented at a network meeting in April. That information was also discussed on a conference call with investors, Feuerstein said. ASCO accepted the abstract on the premise it contained new or updated information. Aditya Bardia of Harvard Medical School, the lead investigator of IMMU-132, told thestreet that she was unaware of the previous presentation of the data.
http://www.biospace.com/news_story.aspx?StoryID=421981
Breaking: ASCO removes $IMMU late-breaker IMMU-132 presentation in TNBC from #ASCO16 due to company violating abstract confidentiality. (h/t @adamfeuerstein)
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123061617&txt2find=immu
Sounds like TauRX's drug lacks dose response -
The high share price in 2008 was probably due to the Patrick Cox newsletter. The O/S was miniscule at that time.
From 2008 up until 2013, Anavex's CEOs were unable to raise funds to advance A2-73. Alzheimer's Disease drugs had a miserable history of failure and Anavex's CEOs were not well connected.
Dr. Missling became CEO in mid 2013. Anavex announced that they had raised funds at he same time.
http://www.anavex.com/?news=anavex-raises-2-6-million-in-private-placement-and-conversion-of-liabilities-enters-into-10-million-financing-commitment-and-appoints-ceo
Dr. Missling discussed the challenge of raising money here -
http://lifescienceleadermag.epubxp.com/i/547536-aug-2015/47
Anavex reported the first data from their Phase 2a trial in July, 2015. This was followed by the 1/4 RS and Nasdaq up listing. The price went up to nearly $15.
Then the hit pieces from Street Sweeper, SA, Adam F, and others tanked the price to $3.20.
The price recovered to $8 before news of an SEC subpoena and class action law suits. Anavex countered that they believed the subpoena had to do with the volatile trading and the belief that the lawsuits were without merit. Regardless, the price dropped to $3.30.
The price has recovered somewhat and now we are awaiting data again.
Very good entry point, IMO.
You are right. Anavex did not do a podium presentation last year -
bernardc Member Level Monday, 07/20/15 12:13:29 PM
Re: None
Post # of 65222
I emailed Christine why poster and not oral session. And her answer...
"The poster presentation at AAIC is a late-breaking session. A news release will be issued on Wednesday regarding the initial clinical data."
Per AAIC rules, late breaking are submitted between 4/20 and 5/4 and poster only.
Ta da!
It sounds like excellent 12 week data news to me. I have a great deal of confidence that AVXL will be awarded a late breaking oral presentation time slot in the near future!
I don't see the SEC making a determination on when data is ready to be released. Data is not like revenue, earnings, or other events that have a timeframe.
A company can analyze data until they decide it is ready to be released, IMO.
I just looked back further into posts from 6/30/15. The AAIC PR came out before WTCapital's post.
What I was trying to convey is that, apparently, AVXL was not listed as an attendee at the conference as of 6/30, the date of the PR. I couldn't find any AAIC posts before 6/30.
AAIC 2015 -
This post indicates that Anavex was not listed as a presenter before Dr. Missling announced they would present -
W&T Capital LLC Tuesday, 06/30/15 08:27:54 AM
Re: scotsand post# 5347
Post # of 64889
I'm sure the data will be good however just because they are presenting it at the AAIC has no bearing on positive or negative results. Presenting the data at a Scientific gathering is done all the time even with negative results. This is a meeting of the minds. But yea I think it will be great stuff. But where is the enrollment update?
The AAIC PR came out ~20 minutes later -
JB3729 Member Level Tuesday, 06/30/15 08:48:17 AM
Re: None
Post # of 64889
Anavex to Present Initial Clinical Data from the Phase 2a Clinical Trial of ANAVEX 2-73 at the Alzheimer’s Association International Conference (AAIC)
New York, NY – June 30, 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 the presentation of initial clinical data from the ongoing Phase 2a clinical trial of ANAVEX 2-73 during the upcoming Alzheimer’s Association International Conference® 2015 (AAIC), which takes place in Washington D.C. from July 18-23, 2015.
Poster Presentation Details
Title:
New Exploratory Alzheimer’s Drug ANAVEX 2-73 Changes in Electrophysiological Markers in Alzheimer’s Disease - First Patient Data from an ongoing Phase 2a Study in mild-to-moderate Alzheimer’s Patients
Date/Time:
Wed., July 22, 2015
9:30 a.m. - 4:15 p.m.
Location:
Walter E. Washington Convention Center, Hall E
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts, in which at least 32 mild to moderate Alzheimer’s patients will be enrolled. The first part (PART A) is a simple randomized, open-label, two-period, cross-over, adaptive trial lasting up to 36 days for each patient. The second part (PART B) is an open-label extension for an additional 26 weeks, so as to establish a longer drug effect for the patients who wish to continue on an oral daily dose.
The primary objective of the trial is to evaluate the maximum tolerated dose of ANAVEX 2-73 in these patients. Secondary trial objectives include dose response, bioavailability, exploratory cognitive efficacy using mini-mental state examination score (MMSE) and electroencephalographic (EEG) activity, including event-related potentials (EEG/ERP), as well as the relationship of ANAVEX 2-73 as an add-on therapy to donepezil, the current standard of care.
Additional information regarding the ongoing Phase 2a clinical trial is available from the U.S. National Institutes of Health (NIH) clinical trials database at www.clinicaltrials.gov.
About ANAVEX 2-73 and ANAVEX PLUS
ANAVEX 2-73 is an orally available small molecule being investigated for the treatment of Alzheimer’s disease. In addition to preclinical data indicating that ANAVEX 2-73 has the potential to prevent, halt and/or reverse the course of Alzheimer’s disease, there was a highly encouraging synergistic effect observed between ANAVEX 2-73 and donepezil (Aricept®). The combined therapeutic, called ANAVEX PLUS, produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually.
About AAIC
The Alzheimer’s Association International Conference® (AAIC) is the world’s largest forum for the dementia research community. International investigators, clinicians and care providers gather annually to share the latest study results, theories and discoveries to bring the world closer to breakthroughs in dementia science. As part of the Alzheimer’s Association’s research program, AAIC serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community.
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 central nervous system (CNS) diseases 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. 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 in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. 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. 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
SCYNEXIS, Inc. Announces Positive Results in its Proof-of-Concept Phase 2 Study of SCY-078, the First Member of a Novel Class of Glucan Synthase Inhibitors
GLOBENEWSWIRE 3:05 PM ET 6/8/2016
Symbol Last Price Change
SCYX 4.11 +0.01 (+0.24%)
QUOTES AS OF 04:00:00 PM ET 06/08/2016
Confirmation of Clinically Relevant Antifungal Activity of SCY-078 in Patients with Candida Infections
Company to Host a Conference Call Today at 5:00pm ET to Discuss Results
JERSEY CITY, N.J., June 08, 2016 (GLOBE NEWSWIRE) -- Drug development company SCYNEXIS, Inc.(SCYX) today announced top line results of its Phase 2 study of two dose regimens of oral SCY-078 versus the current standard of care, oral fluconazole, in patients with acute vulvovaginal candidiasis (VVC), also known as vaginal yeast infection.
“We are delighted with the positive results of this proof-of-concept study that was designed to provide evidence of the antifungal activity of orally administered SCY-078 in patients with Candida infections and to assess the potential clinical utility of this molecule in the VVC indication,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS(SCYX). “These results are supportive of our planned development of SCY-078 as a novel antifungal class for the treatment of VVC as well as invasive candidiasis, a serious and difficult to treat fungal infection, as the same pathogens are involved in both diseases. We look forward to providing additional updates as our clinical programs advance.”
This Phase 2 study enrolled 96 patients with moderate to severe acute VVC. Both dose regimens of SCY-078 showed similar activity, and results from the Per-Protocol (PP) population were consistent with the Intent-to-Treat (ITT) population (patients who receive at least one dose of study medication). The efficacy analysis provides compelling evidence of the antifungal effect of SCY-078 that appears comparable to fluconazole in the treatment of VVC. Results seen with fluconazole in this trial were in-line with results published in fluconazole’s label.
Intent-to-Treat (ITT) Population
Combined SCY-078
(n=64) Fluconazole
(n=32)
Clinical cure (1) 78.1 % 65.6 %
Mycological eradication (2) 70.3 % 68.8 %
Therapeutic cure (3) 56.3 % 56.3 %
Clinical cure is defined as resolution of signs and symptoms of infection without further antifungal treatment, specifically all signs and symptoms that had a score of 2 or 1 at baseline should be 0 and those with a score of 3 at baseline should be 0 or 1 at the test of cure visit, in line with FDA draft guidelines.
Mycological eradication is defined as a negative culture for baseline yeast pathogen.
Therapeutic cure is defined as patients who achieve both clinical cure and mycological eradication at test of cure visit.
There were no severe or serious adverse events in any of the three treatment groups, and there were no discontinuations. While a considerably higher rate of gastrointestinal-related adverse events (diarrhea, nausea, vomiting and abdominal pain) were reported in the SCY-078 treatment arms as compared to the fluconazole arm, all events were mild to moderate in severity and transient in nature, with the majority of the events lasting one day or less after the initiation of SCY-078 dosing. There were no clinically relevant changes noted in vital signs, physical exam findings, chemistry, or hematology parameters. With antifungal activity now established, and as part of the Company’s development plan going forward, a range of doses and treatment durations will be explored to identify the optimal therapeutic window for SCY-078 in VVC.
“New treatment options for patients with vulvovaginal candidiasis are needed, particularly for patients with recurrent episodes of VVC or those caused by azole-resistant Candida strains,” said Dr. Jack Sobel, Professor of Medicine at Wayne State University's School of Medicine. “The evidence of clinical antifungal activity of SCY-078 observed in this proof-of-concept VVC study is an important step forward in the development of this novel compound, which holds promise for addressing current unmet needs in the treatment of recurrent VVC and invasive fungal infections.”
Conference Call Details
SCYNEXIS (SCYX) will host a conference call today at 5:00pm Eastern Time to discuss the results and provide an update on the SCY-078 development program. The call can be accessed by dialing 844.309.3707 or 661.378.9467 prior to the start of the call and referencing conference ID: 27542113. The conference call will also be webcast live over the Internet and can be accessed on the “Investors” section of the SCYNEXIS(SCYX) website, www.scynexis.com.
About the Study
The Phase 2 study is a randomized, multicenter, active controlled, evaluator-blinded study of oral SCY-078 compared to oral fluconazole in adult female patients with acute vulvovaginal candidiasis (VVC). A total of 96 patients with an acute moderate to severe, symptomatic episode of VVC were randomized in a 1:1:1 ratio to receive either three daily doses or five daily doses of SCY-078 or oral fluconazole, at the labeled dose regimen of 150mg single dose. This was a pilot investigation and not powered to demonstrate a statistically significant difference in any of the parameters tested. Efficacy was evaluated based on the proportion of patients achieving clinical cure, mycological eradication and therapeutic cure (combination of both clinical cure and mycological eradication) at day 24 (+/-3) after initiation treatment, in line with draft guidelines from the FDA.
About SCY-078
SCY-078 is a glucan synthase inhibitor in Phase 2 development as an oral treatment for fungal infections caused by Candida and Aspergillus species. SCY-078 is a semi-synthetic derivative of the natural product enfumafungin—a structurally distinct class of glucan synthase inhibitors. SCY-078 combines the well-established activity of glucan synthase inhibitors (similar to echinocandins) with the flexibility of having intravenous (IV) and oral formulations (similar to azoles). By belonging to a chemical class distinct from other antifungals, SCY-078 has shown in vitro and in vivo activity against multi-drug resistant pathogens, including azole and echinocandin resistant strains. SCY-078 is currently in Phase 2 development with the oral formulations in two indications: invasive candidiasis and vulvovaginal candidiasis. The U.S. Food and Drug Administration (FDA) granted Fast Track, Qualified Infectious Disease Product (QIDP) and orphan drug designations for the oral and IV formulations of SCY-078 for the indication of invasive candidiasis (including candidemia). The FDA also granted Fast Track and QIDP designations of SCY-078 for the indication of invasive aspergillosis.
About Vulvovaginal Candidiasis
VVC, commonly known as a "yeast infection," is usually caused by Candida albicans and typical symptoms include pruritus, vaginal soreness, irritation and abnormal vaginal discharge. An estimated 75% of women will have at least one episode of VVC during their lifetime and 40%-45% will experience two or more episodes. As many as 8% of these patients suffer from recurrent VVC, defined as experiencing at least four episodes a year. Current treatments for VVC include topical antifungals and the use of prescription oral antifungals such as fluconazole, which has a therapeutic cure rate of 55% as reported in the label. There are no products currently approved for the treatment recurrent VVC.
About SCYNEXIS, Inc.(SCYX)
SCYNEXIS (SCYX) is a pharmaceutical company committed to the development and commercialization of novel anti-infectives to address significant unmet therapeutic needs. We are developing our lead product candidate, SCY-078, as an oral and IV drug for the treatment of several fungal infections, including serious and life-threatening invasive fungal infections. For more information, visit www.scynexis.com.
Forward Looking Statement
Statements contained in this press release regarding matters that are expected to occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, any statements related to subsequent development activities of SCY-078, the potential to limit adverse events in future studies and the potential benefits of SCY-078 for treatment of VVC. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, risks inherent in SCYNEXIS'(SCYX) ability to successfully develop SCY-078, including SCYNEXIS'(SCYX) ability to obtain FDA approval for SCY-078, the expected costs of studies and when they might begin or be concluded, and SCYNEXIS'(SCYX) reliance on third parties to conduct SCYNEXIS'(SCYX) clinical studies. Risks are described more fully in SCYNEXIS'(SCYX) filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS(SCYX) undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT:
Media Relations
Heather SavelleMacDougall Biomedical Communications
Tel: 781.235.3060
hsavelle@macbiocom.com
Investor Relations
Susan KimArgot Partners
Tel: 212.203.4433
susan@argotpartners.comImage: Primary Logo
Source: SCYNEXIS, Inc.(SCYX)
2016 GlobeNewswire, Inc.
A non-disclosure agreement (NDA), also known as a confidentiality agreement (CA), confidential disclosure agreement (CDA), proprietary information agreement (PIA), or secrecy agreement (SA), is a legal contract between at least two parties that outlines confidential material, knowledge, or information that the parties wish to share with one another for certain purposes, but wish to restrict access to or by third parties. It is a contract through which the parties agree not to disclose information covered by the agreement. An NDA creates a confidential relationship between the parties to protect any type of confidential and proprietary information or trade secrets. As such, an NDA protects non-public business information.
NDAs are commonly signed when two companies, individuals, or other entities (such as partnerships, societies, etc.) are considering doing business and need to understand the processes used in each other's business for the purpose of evaluating the potential business relationship. NDAs can be "mutual", meaning both parties are restricted in their use of the materials provided, or they can restrict the use of material by a single party.
It is also possible for an employee to sign an NDA or NDA-like agreement with an employer. In fact, some employment agreements will include a clause restricting employees' use and dissemination of company-owned confidential information.
https://en.wikipedia.org/wiki/Non-disclosure_agreement
No timeframes are set in stone. They have to be adjusted as events materialize.
I thought Anavex gave a good explanation here -
Pazzo1212 Thursday, 03/17/16 06:39:36 PM
Re: blu_1 post# 57177
Post # of 57652
Here's the email I received from IR yesterday:
Thank you for your email and support of Anavex Life Sciences Corp. (Nasdaq: AVXL).
In the AAT presentation (http://www.anavex.com/files/2016-03-12_AAT_Anavex_Presentation_2016.pdf), slide 24 demonstrates encouraging functional measurement of interim 12-week data, which was originally presented at CTAD.
Complete longitudinal data for the 12-week time point of PART B will be provided once this data becomes available. This is not yet available to the company. As stated in the third bullet point on slide 26 of the AAT presentation, please be assured that it will be issued once available, however we are unable to provide guidance on the timeline. The details relating to pharmacokinetics and pharmacodynamics are being fully analyzed so that there can be no doubt as to the cause-effect relationship of the 12-week efficacy data and this must be completed before it can be released.
The company is excited about the data received to date and by the request for an additional two-year extension from patients and caregivers, as announced in a press release March 10, 2016.
Please do not hesitate to contact our office if we can be of further assistance.
On behalf of Anavex Life Sciences Corp.,
Investor Relations
Toll Free (North America): 1 (866) 505-2895
Outside North America: +1 (416) 489 0092
Fax: +1 (416) 352 5239
ir@anavex.com
I think there is a very high probability that Anavex presents data at AAIC and that the data will be very good.
I'm not nearly as stressed out heading into this data release as I was last year. The data release last year was the first from the 2a trial. No efficacy in humans had been shown prior to that data release.
Last year AVXL entered AAIC as late breaking and presented. If I remember correctly, there were 4 companies with late breaking presentations.
Last year AVXL announced on 6/30 that they would present data on 7/22.
Weekly Biotech Report on upcoming FDA decision for Adamis Pharmaceuticals Corp (NASDAQ:ADMP) Epinephrine pre-filled syringe for anaphylaxis
http://marketexclusive.com/weekly-biotech-report-upcoming-fda-decision-adamis-pharmaceuticals-corp-nasdaqadmp-epinephrine-pre-filled-syringe-anaphylaxis/7392/?icd1
I see that now. I thought you were referring to blinded placebo trials.
Reasons for not blinding the Phase 2a trial -
Enough cash to run a 32 patient trial
Very expensive (dilution wise) to raise money for a larger AD trial on a drug that has yet to show efficacy
Collect A2-73 data on all 32 patients as opposed to 16 patients with the other 16 on placebo
There is no intent to gain approval on the results from this trial
There is already a ton of information available on the placebo effect in AD trials
If the efficacy data from the 2a trial is anywhere close to the computer simulation then the money spent on placebo patients at this stage of the game will be a complete waste of money
Placebo data is only important in trials where the drug is not shown to be very efficacious
A standard trial gives each patient a particular dose.
An adaptive trial can give each patient any number of doses and looks for dose response and, I'm sure, PK/PD data at each individual dose.
We were told that AVXL's oral doses would be 30 and 50. Yet, somehow it was determined that 14 was the dose that stopped progression. Who knows what all they looked for and how many different doses were given to each patient.
AVXL's adaptive clinical trial appears to be more complicated than a statistical standard trial.
From IR -
In terms of the number of participants in the Phase 2a trial, this is because of the adaptive design of the trial (versus a trial that includes patients receiving a placebo). Here is a summary of comments made by Dr. Tasos Zografidis, the Vice President Clinical Operations of Anavex, and Dr. Christopher Missling, President and CEO, in a conference call earlier this year, which provides additional insight into the reasons Anavex is using an adaptive trial design.
+++++
TZ: For background information, there are two approaches in a clinical trial. One is the placebo controlled study. Here you have to estimate the number of patients needed if you are testing a hypothesis since you need a certain power; you need a certain number of patients. However, the methodology that we are using is very different, we just measure whatever effect is there. If you measure the effect and are able to reproduce it mathematically (mathematical modeling), then you can calculate the number of patients needed so as to see the effect. By using the adaptive trial methodology with population PK modeling, we are implementing mathematical modeling along with probability density function statistical methodology. That means that the results are looked at in confidence intervals. In the first approach you first estimate the number of patients and then you "see" the effect. In the second approach you first measure the effect and then you calculate the patients needed so as to truly "see" the effect. So, these are two opposite approaches with same outcome.
CM: We want to get a signal and the adaptive clinical trial allows us to increase the dose or decrease the dose until we see a signal. The mathematical model that Tasos speaks of sufficiently allows us to measure the data from these 32 patients because we are measuring many data points in this trial, from blood samples and the various cognitive tests, which allows for sufficiently precise data to learn how the drug works in order to select the number of patients needed for a Phase 3 pivotal trial. The number could range anywhere from 100 to 300 and the goal is to figure that number out.
The key is to understand the difference between a statistical standard trial, which is based on the placebo versus active dose in a number of patients, and the adaptive trial design statistical method used. The FDA has written a very eloquent guideline which you can find on the fda.gov website (http://www.fda.gov/downloads/Drugs/Guidances/ucm201790.pdf). The FDA states that with the adaptive trial design, which we are using, you need fewer patients, you are able to do this in a shorter period of time, you are more likely to demonstrate the effect of the drug, and you are getting more information on the treatment effect as well as a better understanding of dose response information in subgroups. Lastly, you are able to identify and optimize the parameters needed for Phase 3 effects. So, this Phase 2a trial is a very important stepping stone and building block for a successful Phase 3 trial. We want to avoid the same failure that the other Alzheimer drug trials experienced, and by implementing a different, innovative trial design for ANAVEX-73 in Alzheimer’s treatment, we are leading a more efficient study than a conventional study.
Sure, there are examples of drugs that run into problems after approval. However, this is not typical.
There are also examples of drugs that work for far more indications than what was shown in their trials.
I stated that we would probably know by now if A2-73 had safety issues. I think this is a fair statement.
A2-73 clinical trial safety data -
From the second Phase 1 trial -
The Phase 1 clinical trial was a randomized, double-blind, placebo-controlled study in 22 healthy male volunteers. The participants received single, ascending oral doses of ANAVEX 2-73 ranging from 1 mg to 60 mg. The primary objective of the trial was to evaluate safety and tolerability together with pharmacokinetic parameters.
•Safety: No serious side effects were reported. There was no study discontinuation due to adverse events. No dose-limiting adverse events or lab abnormalities at doses of 1, 10, 30, 40 and 50mg were observed.
•Tolerability: Maximum tolerated dose (MTD) of ANAVEX 2-73 was defined as 55mg. Observed adverse events at doses above the MTD included dizziness and headache, which were moderate in severity and reversible. These side effects are often seen with drugs that target CNS conditions, including Alzheimer’s disease. Across all doses, there were no differences in blood pressure and resting heart rate. Analysis of electrocardiograms (ECG) did not reveal any dose-related or time-dependent changes and the QT interval did not reveal any clinically significant changes. Additionally, no sign could be detected for any dose- or time-dependent changes for any of the hematology, biochemistry, and coagulation parameters.
•Pharmacokinetics (PK): ANAVEX 2-73 was determined to be suitable for daily oral dosing based on its PK profile. PK data revealed biotransformation of ANAVEX 2-73 to its main metabolite, which also actively targets sigma-1 and muscarinic receptors like its parent drug ANAVEX 2-73. Both maximum plasma concentration (Cmax), which relates to absorption and distribution of the drug in the blood, and area under the plasma concentration-time curve (AUC), which represents the total drug exposure over time, showed dose-proportional linear increases for both ANAVEX 2-73 and its metabolite. The biological half-life (T1/2) for ANAVEX 2-73 was 8.56 hours and 28.74 hours for its metabolite.
http://www.anavex.com/?news=anavex-announces-positive-phase-1-data-for-anavex-2-73-lead-candidate-for-the-treatment-of-alzheimers
There aren't too many of us on this board that don't know that A2-73's safety profile is excellent. This statement is FUD -
Does anybody know if UNXL's touch screen technology can be used in Apple's 3D Touch screens? It appears that Android is going to come out with screens similar to 3D Touch.
I sent a question to the Company and didn't hear back.
I bought for the first time during pre-market this morning.
GLTA
AVXL will seek BTD. We just don't know when.
Closetinvestor stated this -
The detailed data AVXL is now compiling could prompt a BTD application -
Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained. Because the primary intent of Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that Breakthrough Therapy designation requests will be made after the submission of an original BLA or NDA or a supplement. FDA will respond to Breakthrough Therapy designation requests within sixty days of receipt of the request.
http://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm
Renoit7 Thursday, 11/26/15 03:10:05 PM
Re: Amatuer17 post# 40465
Post # of 63764
I contacted them regarding an application for Breakthrough Therapy Designation and the response I received this morning was:
"The company intends to pursue Breakthrough Therapy Designation and material information will be shared with all investors according to Regulation FD"
My question was if they were planning on applying for BTD and if they would be announcing their application or if they'd wait until the received a response from the FDA to disclose. So I never really got my full question answered, and I'm not even sure what the 'FD' is referring to. Anyone with an experience where BTD was given and if the company announced their application or not?
If I were making the decisions for Anavex and I had groundbreaking Alzheimer's data to report, I'd present that data in front of my peers at the world's #1 AD conference (AAIC), in July.
If I had so-so data to report, I'd PR it as soon as I had it.
What gave you the impression that Anavex is touting their drugs?
It makes little sense for an investor to criticize the Company he/she has invested in on a daily basis. There is so much that we don't know. Any investment requires a level of trust that the management is doing the right thing.
I have felt for some time that Anavex will report data at the AAIC. The AAIC is to Alzheimer's what ASCO is to oncology. I hope that Anavex plans to grab center stage at the AAIC.
I might be right or wrong. Whatever, I have invested in Anavex and will not dog them on a daily basis while they pursue their goals.
There is nothing comical about today's PR and the rat sweat comment.
Here's a doctor's take on today's PR -
Big news for the epilepsy world!
by dadofmarcmax • 45 minutes ago Flag
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Ok, so infantile spasms (new nomenclature is "epileptic spasms") mostly occurs between 4 months -7 months of age but can occur at any age and presents as sudden flexion of arms,legs with tonic posturing. The EEG shows a pattern called hypsarrythmia and the spasms show a classic slow wave followed by generalized paroxysmal fast activity with electrodecrement. It is thought to be the result of some sort of insult to the brain either structurally or related to a genetic defect.....many causes. Furthermore, spasms are thought to occur as a result of an inflammatory cascade, hence ACTH as a strong corticosteroid works (strong anti inflammatory properties). I have always stated that 2-73 works to stop neuroinflammation and with this news; we may have a new and less potentially dangerous medication than ACTH to treat spasms.
West syndrome (where spasms are seen), if not controlled early after diagnosis leads to devastating developmental consequences.
This is BIG news in the epilepsy world. Again, this is why I'm so heavily invested in AVXL; the potential to change neurology as I know it is huge! I'm glad I'm in early.