Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
From the februari call we’ll see the results tomorrow I assume
Let me cover latter first. It was a very important strategic decision to start the new clinical trials after genetic data were collected and analyzed. We believe Anavex can be a pioneer with the inclusion of advanced genomic biomarkers into late-stage CNS precision medicine trials, including our Rett syndrome, Alzheimer's disease and Parkinson's disease trials. Using genomic biomarker-driven clinical trials and therapies are bringing great success to patients in the oncology space. We believe the CNS space is ready for this precision medicine approach. The result should allow to more precisely target patients based on specific genomic profiles that may be highly responsive to ANAVEX2-73. And hence could significantly increase probability of success in clinical trials. That is in cancer treatments involving genomic biomarkers are very good examples of the significant success, which could be accomplished with this approach.
We have just completed both RNA and whole exome DNA genome sequencing from ANAVEX2-73 treated patients, utilizing Illumina HiSeq 2500 Next Generation Sequencing technology. The analysis of this data has characterized several genomic alterations in well-characterized targets that have the potential to be used as biomarkers, which we plan to use to identify optimal patients in forthcoming clinical trials. This novel, precision-medicine approach will enable enriched clinical trial populations, more robust regulatory submissions and better characterized clinical trials designs. Full details of the genomic sequencing analysis have been submitted for presentation at a upcoming scientific meeting.
From the results call
Analysts on the Biogen earnings call pushed for more details about the Phase 2 trial, its readout and the next steps the company is planning to take with regard to developing and filing BAN2401. They didn't get many answers.
"Look, our next steps are to talk to FDA and other regulators. We'll see what they say. And I think it's too early to speculate as to whether or not we can file with this," Biogen's Chief said
Indeed
At least one recent trial has increased hopes for progress in Alzheimer's drug development. Biogen reported a Alzheimer's drug breakthrough in early July with positive clinical trial results for BAN2401, the first anti-amyloid drug to achieve statistically significant results at a later stage of Alzheimer's, 18 months. Still, Biogen’s drug is far from coming to market, with a phase three trial not expected until late 2019 or 2020. And Biogen officials stressed that the results showed the drug could slow the cognitive decline associated with Alzheimer's, but it did not stop the decline or reverse it.
Ken has to come with some explaination
Maybe they want to put some pressure on a partner.
Clinical trials keeps running and a partner could do a MAA with the Europeanen Union again ?
The Company continues to believe that the results from the GOG-0265 study are clinically meaningful and provide proof-of-concept that axalimogene filolisbac demonstrated clinical activity in metastatic cervical cancer. The withdrawal of this application does not impact the ongoing clinical trials of axalimogene filolisbac. As previously communicated, Advaxis is actively seeking a partner to support the late-stage cervical cancer program.
Someone would give it a try ?
It would be interesting to known what Biogen is doing with the Anavex drug on MS not ?
http://c.newsnow.co.uk/A/945158037?-17462:2765
Nice analyse, sceptical at the end
Anavex sets up trial of ‘triple-action’ Alzheimer’s drug
Nice article just out alzheimer news 24 7
UP 12% premarket already news coming ?
Yet another
PhIII Alzheimer’s drug goes bust — and a major setback at Eli Lilly and AstraZeneca may doom the class
Great webcast today. Just listen I think we’ll know the tier1 partner within a few weeks
Apr 2611:25
Conference pass
Empowered educated patients influencing pre-clinical development and working with industry to optimize drug discovery
Rare Disease Advocacy World
Patient groups role guiding research, disease understanding, supporting pre-clinical development and follow up experiments
Driving translational research and the influence on formulation, routes to delivery and overall clinical development
Effective partnerships between advocacy and industry to expand collaborations that can support enrollment and physician engagement
Christopher MisslingChristopher Missling,President and CEO, Anavex Life Sciences
Steven KaminskySteven Kaminsky,Chief Science Officer, International Rett Syndrome Foundatio
Is the Corporate presentation updated ?
- A study released Monday found that Alzheimer's-related deaths have more than doubled since 2000, and are only expected to rise.
Alzheimer's is the sixth-leading cause of death in the U.S., according to the Centers for Disease Control and Prevention. The report said that while other major causes of death, such as heart disease, have decreased, Alzheimer's-related deaths are only expected to increase as the disease is currently the only top 10 cause of death that cannot be prevented, cured or even slowed.
The report by the Chicago-based Alzheimer's Association estimates that 5.5 million Americans age 65 and older are now living with the disease, 220,000 of them in Illinois alone. Alzheimer's-related deaths increased nationally by 123 percent from 2000 - 2015. By 2025, the organization expects an 18 percent increase in Illinois and an increase of nearly 29 percent nationally.
The disease's increasing prevalence has a major economic impact too. The study found that the average projected cost of health and long-term care for an individual with Alzheimer's can range from $360,000 - $424,000.
Corporate presentation has been updated
April 25 - 27, 2018
Gaylord National Harbor Hotel, Oxon Hill, MD
THE 8 TH GLOBAL ORPHAN DRUG CONFERENCE AND EXPO
Strategy, Regulation and Opportunity for Pharma, Biotech and Investors in Rare Diseases
Missling speaking and Kaminsky from Rett Syndrome Foundation also
Article
AstraZeneca Delays Final Results of Failed Lung-Cancer Trial
And
EMA set to also revise guidelines of Alzheimer’s trials
Published on 28/02/18 at 04:45pm
The EMA, following on from the FDA’s lead earlier this month, has announced that it will revise its guidelines on clinical trial studies for the treatment of Alzheimer’s disease from 1 September 2018 onwards.
The move is remarkably similar to the FDA’s move, in that it will allow for clinical trials to be focused at an earlier point disease-progression point – in some cases, before clinical symptoms have become discernible.
In the press release on the updated guidance, the EMA stated: “Recent progress in understanding the pathophysiology of Alzheimer’s disease suggests that the biological changes associated with the disease start to occur as early as 10 to 20 years before clinical symptoms start to appear. Many of the experimental medicines are therefore investigated in earlier disease stages as certain treatments may be more effective at that stage than later in the illness.
“Currently available medicines for Alzheimer's disease only treat its symptoms. However, a number of therapies under development are targeting the biological mechanism of the condition to try and modify the course of the disease.”
Though there are currently still a number of therapies in the pipeline for the treatment of the disease, all of the ones that have posted results have failed, often crushingly.
MSD and Lundbeck both recently posted big failures when a lot of hopes were pinned on their treatments, alongside numerous other defeats that have filtered through early into the new year.
The most notable, and perhaps most worrying, was Pfizer’s decision to pull out of the neuroscience space entirely.
Both the FDA and the EMA’s semi-coordinated action seems designed to ensure that research in the area does not entirely lose support, particularly of big pharma.
The new guidelines will include:
Impact of new diagnostic criteria for Alzheimer’s disease, including early and even asymptomatic disease stages, on clinical trial design
Factors to be considered when selecting parameters to measure trial outcomes at the different disease stages in Alzheimer’s
Potential use of biomarkers in the various stages of medicine development
Design and analysis of efficacy and safety studies
The EMA highlighted that these guidelines had been brought about through discussions with the developers of potential medicines, in order to clarify why treatments have struggled to make it out of clinical trials and onto the market
Nice
Europe follows FDA with plans to help early Alzheimer's drugs
At the website
UPCOMING EVENTS
Barclays Global Healthcare Conference
March 13, 2018 - March 15, 2018
2018 Keystone Symposia on Cancer Immunotherapies: Combinations
March 23, 2018 - March 27, 2018
Take a look at pascal biosciences (pas.v) ?
FDA floats new rules for testing Alzheimer's drugs
Nice article
FDA opens new path for Alzheimer’s therapy as failures mount
Nice
Very nice call, 2018 will be great with cashflow already ok by end of year
Scientists toss another Alzheimer’s program into the scrap heap as PhII fails
Boehringer this time
Great e-mail, I hope we will get some answers.
I listened to the call, I think Missling was upbeat and sure about the future.
BIO CEO Investor Conference on Feb 12-13, 2018
February 12 - February 13
Dr. Christopher Missling, President and CEO of the BIO CEO "Buzz of BIO" winner, Anavex Life Sciences , will be presenting at 9:45am on Feb. 12th in the Wilder room.
New at the website
Immunotherapy: A New Strategy for the Treatment of Cervical Cancer. Interview with Dr. Christian Marth and Dr. Sharad Ghamande
Bill Gates reveals his father suffers from Alzheimer's disease - inspiring him to invest $100 million in research for fear HE will get it too
Bill Gates, 62, revealed in an interview that his father Bill Gates Sr, 92, suffers from the neurodegenerative disease Alzheimer's
The billionaire Microsoft co-founder announced in November that he is donating $100 million of his personal fortune to research
Of that, $50 million will go to the Dementia Discovery Fund for innovative research
The rest will go toward an international research registry and speeding up recruitment for clinical trials
Read more: http://www.dailymail.co.uk/health/article-5330687/Bill-Gates-reveals-father-suffers-Alzheimers.html#ixzz55gu5tVyg
Follow us: @MailOnline on Twitter | DailyMail on Facebook
It is the website now
Down again anyone ?
Website down ?
Another 8-k on distribution agreement
KANSAS CITY, Kan., and PRINCETON, N.J., March 19, 2014 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for cats, dogs and other companion animals, and Advaxis, Inc. (NASDAQ: ADXS), a biotechnology company developing the next generation of cancer immunotherapies, today announced a global licensing agreement for Advaxis' ADXS-cHER2 for the treatment of osteosarcoma in dogs and three additional cancer immunotherapy products for the treatment of three other types of cancer. Each of the four licensed products is based on Advaxis' platform immunotherapy technology, which Advaxis is developing for the treatment of human cancers on a global basis. Under the agreement, Aratana will have exclusive rights to develop and commercialize the licensed immunotherapies for pet health applications, and will focus initially on developing ADXS-cHER2 for osteosarcoma.
Under the agreement, Aratana made a one-time upfront payment to Advaxis of $1 million and an additional $1.5 million equity investment in Advaxis common stock and warrants. Aratana agreed to pay up to an additional $6 million in clinical and regulatory milestones for each of the four products, assuming approvals in both cats and dogs in both United States and the European Union. In addition, Aratana agreed to pay up to $28.5 million in commercial milestones. Upon regulatory approval and commercialization of the immunotherapies, Aratana agreed to pay Advaxis a tiered royalty ranging from mid-single digit to 10% on net sales.
ADXS-cHER2 was validated in an ongoing clinical study in 13 client-owned dogs with osteosarcoma, conducted by Dr. Nicola Mason at the University of Pennsylvania School of Veterinary Medicine and sponsored by Advaxis. In the study, dogs treated with ADXS-cHER2 immunotherapy after the standard of care (amputation and follow up chemotherapy), had a statistically significant prolonged overall survival benefit (p=0.032) compared with dogs that received standard of care without ADXS-cHER2. The median survival time for dogs that did not receive ADXS-cHER2 immunotherapy was eight months, whereas the median survival time for those dogs treated with ADXS-cHER2 has not yet been reached. The first four dogs treated with ADXS-cHER2 are alive, with each dog surviving over 21 months. The majority of treated dogs are tumor-free. There were no short- or long-term complications associated with the immunotherapy and only low-grade, transient toxicities were reported in the study.
Steven St. Peter, M.D., President and Chief Executive Officer of Aratana Therapeutics, stated, "We strive to accelerate the most innovative and promising new therapies for pets, and we are very encouraged by the results Advaxis has generated for ADXS-cHER2 in osteosarcoma, as well as the overall potential of their platform. Immuno-oncology is one of the most exciting advances in treating human cancers, so expanding our oncology portfolio of first in class, species specific antibodies to include Advaxis' immuno-oncology products is a natural fit. We are also particularly excited to work with the people at Advaxis and at The University of Pennsylvania, where many of our team have had long-standing relationships."
Daniel J. O'Connor, President and Chief Executive Officer of Advaxis, commented, "We admire Aratana's dedication to elevating cutting-edge drugs like ADXS-cHER2 to become potentially market-leading immunotherapies in this growing space. Given the Aratana team's combined decades of veterinary drug development experience and their leadership position in pet therapeutics, they are the ideal partner for maximizing the value of our cancer immunotherapies for pets. With upfront and potential near term multimillion dollar milestones from 16 potential approvals, this collaboration strengthens our financial ability to further advance our proprietary immunotherapies for the treatment of human cancers."
Maybe we will hear about upcoming announcements as said in the PR ?
Let’s make an opinion after the webcast today.
Some news about Ranzcp conference and Stephen Mcfarlane ?