AVR118: Spreading the word....Exposure
(This one would have been interesting if we could have read it: "China Chamber of Commerce of Medicines and Health Products, Importers and Exporters"......hmmmmmmmmmm....)
An Interview with Eli Wilner, Chairman, and James T. D'Olimpio, M.D.,
Member, Scientific Advisory Board, and Spokesperson at Large, Advanced
Viral Research Corp., Yonkers, New York
A Life-Changing Drug?
EDITORS NOTE: A past Bryant Fellow of the Metropolitan Museum of Art, Eli Wilner holds a B.A. from Brandeis University and an M.A. from Hunter College.
Dr. James D'Olimpio, who is triple board certified in internal medicine, medical oncology, and hospice/palliative medicine, is also director of supportive oncology and the Palliative Care/Cancer Pain Service at North Shore University Hospital in Manhasset, New York, as well as an assistant professor at New York University's medical school.
COMPANY BRIEF: Headquartered in metropolitan New York, Advanced Viral Research Corp. (Nasdaq: ADVR;
www.adviral.com) is a biopharmaceutical firm dedicated to improving people's lives by developing and bringing to market new effective therapies for viral and other diseases. Its primary involvement at present is its peptide-nucleic acid AVR118, now in clinical trials in Israel for the treatment of cachexia, or body wasting, in patients with AIDS.
You've reported quite a remarkable breakthrough in the battle against AIDS. Please elaborate.
D'Olimpio: The group we've assembled is basically trying to improve the quality of life of patients suffering from HIV disease. Now, there are many elements to that, the most important being the experience that patients endure while they're receiving treatment. Treatments are much more successful than they used to be, but a significant number of patients still suffer the ill effects of treatments along with the effects of the disease. Cancer patients suffer in similar ways from toxic therapies.
As it stands now, our company has developed the platform of a very sophisticated technology - a series of proteins put
together in what's called a peptide-nucleic acid complex. The clinical manifestation of this particular complex is in modulating the immune system. When the patients with HIV disease we've been working with in Israel started to take our Product R, or AVR118, in clinical trials, the preliminary results were such that every patient experienced a positive clinical benefit.
Now, a positive clinical benefit is sometimes difficult to describe. What it means is that each patient told his doctor he was feeling better. That's the bottom line. They feel as if the treatment they're receiving for HIV disease is actually helping them. They're feeling as if their quality of life has improved to the extent that they'll continue with treatment.
In addition, our study was designed to measure weight loss. Patients with HIV disease receiving hard therapy - chemotherapy, really - frequently experience weight loss from both the treatment and the disease itself. But when AVR118 was given to the patients, every one either gained weight or stabilized his existing weight. So, the actual thickness of their muscles and fat tissue was measured, their quality of life was measured, and both improved.
When this happened, we were somewhat stunned. I sit on the scientific advisory board of Advanced Viral Research
along with some quite important people in the field, and we certainly were surprised that every patient responded, firstly. And secondly, they responded without any serious adverse events. In other words, there was no toxicity to this study.
Had we been conducting our trials in the United States instead of Israel, the FDA would have required us to increase the dosage of the drug 10 times to prove no significant change in toxicity or any adverse events. We did this successfully, and, what is more, patients on the 10-fold dosage felt even better. That is, the higher the dosage, the more striking the results. Now, we're putting this data together in a statistical format, so we can present it to the scientific and medical communities for appropriate scrutiny and peer review.
When will AVR118 be available in the United States?
D'Olimpio: Fortunately, the Israeli government was willing to use the exact same process that we would have used for FDA approval. Thus, we believe we'll have a significant clinical basis for proceeding on a fast track to get this drug approved in the United States.
And what will this mean for your company?
Wilner: At the moment our company has a market cap of over $100 million. Once the drug goes through Phase II trials in America and shows promising results, there will be an increase in our valuation. And a really large increase in valuation should occur after a Phase III trial, which should be in about three years. By 2007 or 2008, AVR118 should be on the market, as long as it keeps proving its efficacy and safety.
If AVR118 is as successful as you feel, a large pharmaceutical firm should want to acquire it.
Wilner: We're in discussions right now with several companies about licensing segments of our drug, and because it addresses so many disease states, we'll most likely partner with several.
There are actually other aspects of our drug that potential investors should consider. Several specialists have told me that it's the easiest drug to manufacture they've ever seen. It's also extremely inexpensive to produce, and it has a very long shelf life - more than two years thus far at room temperature, which is very good for developing
countries without widespread refrigeration. Plus, it has protection under a very strong patent, issued in March 2003 for 17 years.
My friends, my family, and I have more than $4 million in this company, and we're extremely excited about its prospects.
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VOLUME 27, NUMBER 1 - LEADERS MAGAZINE, INC.
One contribution: FDA’s Fast Track Initiative Cut Total Drug Development
Time by Three Years, According to Tufts CSDD
Tufts Center for the Study of Drug Development
11/13/2003, Site Last Updated: 1/16/2004
BOSTON – Nov. 13, 2003 – The U.S. Food and Drug Administration’s (FDA) fast track program to speed new drugs to market has shaved nearly three years off the time usually required to develop a new drug and win approval, according to a recently completed analysis by the Tufts Center for the Study of Drug Development.
The study found that clinical development time for fast track drugs approved between 1998 and 2003 was, on average, 2 to 2.5 years shorter than for non-fast track drugs.
“The fast track program has had a significant public health impact by speeding access to new drugs, particularly those that treat AIDS, breast cancer, leukemia, and other diseases that afflict millions of patients and result in the loss of tens of thousands of lives every year in the U.S.,” said Tufts Center Associate Director Christopher-Paul Milne.
The Tufts Center examined implementation of the fast track program since it took effect in late 1997. The fast track program aims to expedite development and approval of drugs that address unmet medical needs for serious or life-threatening conditions.
“The fast track program has clearly made a difference,” Milne said. “By 1997, the FDA’s five-year-old accelerated approval regulations had resulted in about 20 approvals; within its first five years the fast track program led to 200 fast track product development designations and another two dozen approvals.”
In addition to generating more designations and approvals, the fast track program is being used for development programs focusing on a growing number of disease indications.
According to Milne, fast track designations for products aimed at treating diseases other than cancer and HIV/AIDS grew from more than 30 in 2001 to more than 50 in 2003.
Other key findings from the Tufts Center analysis:
Although average approval time for fast track biologicals was shorter than that for priority or standard biologicals, longer average clinical development time resulted in a slightly longer total development time for fast track biologicals.
Nearly 10% of fast track designations in 2003 were for diabetes and obesity, reflecting the FDA’s recent emphasis on conditions that contribute significantly to health care costs and that would benefit from innovative treatments.
As more AIDS and AIDS-related medicines became available during the late 1990s, the share of AIDS fast track designations fell by more than half between 2001 and 2003.
About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. The Tufts Center, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums on related topics.
Contact Email: firstname.lastname@example.org
I have complete faith in the management at the FDA....
"The study found that clinical development time for fast track drugs approved between 1998 and 2003 was, on average, 2 to 2.5 years shorter than for non-fast track drugs."
Which means, (for those of us who can add, subtract & multiply), that for some drugs it was actually 1 year shorter, and for others, 5 years shorter.....
The info is all there at the FDA, it just takes a FOI application to get to it....
Yes, kevin, I have faith also. Been there, done that:
Fast Track Designation Request Performance Report
All Requests Received
(March 1, 1998 through December 31, 2003
Fast Track Designated Products Approved since 1998
Through September 30, 2003
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Clearly you haven't been there or done that....
The dates in the FDA chart you referenced are all the NDA approval dates, and are meaningless to the thought provoking questions posed by yank. You could be truly helpful if you would kindly go and find the dates on which each of those pharmaceutical products were granted fast-track status. The FDA has previoulsy informed me that it would require an FOI application.....
Here, I will hold your hand....
Sent: Monday, April 28, 2003 9:36 PM
Subject: FDA Comments
This page gives the NDA Approval Date. Is there a record of the date that the Fast Track designation was granted for each drug ???
From: "CDER DRUGINFO"
Date: 30 Apr 10:37 (PDT)
Subject: RE: FDA Comments
--------------------------------------------------------------------------------The dates are not available on the web site. You can make a Freedom of Information (FOI) request for them. The procedure for making an FOI request is found in the, "Handbook for requesting information...." on the FOI web site, http://www.fda.gov/cder/foi
Proposed Rule Amendments, Penny Stock
(Voluntary Disclosure: Position- Long)
While looking at a very short, and a concise analysis over the past say 25 days ADVR might well be ready to break to the upside from here. Much has to do with the need for shares by investors of course. Could be looking better than before and ready to support this appreciation level to kick it up a notch.
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