ADVR'S ASCO PRESENTATION
Anti-cachectic effects of a novel peptide nucleic acid: Preliminary results of a phase 1/11 clinical trial.
Time: Sunday, June 06, 2004, 1:00pm-5:00pm
Presenter: James T. D'Olimpio, MD
Abstract ID: 8087
Poster Number: U8
Session: Patient Care
Sunday, June 06, 2004, 1:00pm-5:00pm
Location: Hall A (right half)
Note: The above states.....The ABSTRACT will contain the Preliminary results of HIV Israel trial. Preliminary results, as I understand it from the company's PR, will encompass 15 patients!!!!
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Forget about ADVR's ability to add
on the additional results from the 2nd round of testing of 7 patients --NOTE
the paragraph on "Late-Breaking Sessions"!!! But, that's not to say if and
when ADVR gets the INDA ready, they will, more than likely, have info on ALL
Abstract Distribution Procedures for 2004
Last Updated: March 01, 2004
Each year, ASCO reviews its abstract distribution procedures to ensure that the organization is most effectively meeting the needs of its members. After the 2003 Annual Meeting, ASCO surveyed its members to seek input on the process instituted last year, in which abstracts were first made available on site at the meeting. Based on member feedback and further deliberations, ASCO has revised its abstract distribution procedures for the 2004 meeting.
The changes to ASCO's abstract distribution procedures were
instituted in order to better serve the educational needs of the organization's 20,000 members, who use the abstract book to plan their attendance and schedule at the meeting, digest data, and make the most of the educational opportunities that the meeting provides.
This year, ASCO will distribute the 2004 Proceedings containing all non-late-breaking abstracts to its members approximately two weeks in advance of the Annual Meeting. Recipients of the book are subject to a confidentiality policy, which states that the information contained
in the abstracts may not be reported on, used for stock trading purposes, or shared prior to presentation at the meeting. As is the case every year, all abstracts are embargoed for news coverage until the studies are publicly presented at the meeting. Non-ASCO members who attend the Annual Meeting can pick up the ASCO Proceedings onsite.
An online program planner, including all session descriptions and abstract titles, will be made available six weeks in advance of the meeting. Full abstracts will be made available online to both members and the public at the conclusion of the meeting. ASCO.org's Virtual
Meeting will be posted within a week of the meeting and will feature all oral and poster presentations.
This year, ASCO will be accepting late-breaking abstracts into the Annual Meeting. The abstracts will feature the results of major Phase III trials for which final data were not available at the time of ASCO's regular abstract submission deadline. Late-breaking abstracts
will not be available prior to the meeting, but distributed to all attendees on-site in a separate publication.
JCO Annual Meeting Abstract Supplement
An updated version of the ASCO Proceedings – which will include late-breaking abstracts – will be mailed as a supplement to a July issue of the Journal of Clinical Oncology (JCO). This JCO Annual Meeting Abstracts Supplement presents the abstracts in a citable format. All
members and JCO subscribers will automatically receive this
Isn't ADVR supposed to be
presenting at an Investor's Conference on June 5?
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Who will be presenting at the
Investor's Conference? With Gallantar gone, will Bookman take the stage?
Will Hawkins attend the Dr. Jim's ASCO Abstract poster presentation in New
Orleans on the 6th, and also attend the Investor's Conference in New York on
the 5th? Busy weekend, eh???
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"where are the other 15?"
Try to follow along, Allen, if you can:
15 patients (preliminary results)
7 patients (added on for testing "after" the ASCO "sign up" in December 2003)
According to the latest SEC report --- the remaining PATIENTS HAVE NOT YET BEEN RECRUITED --- which means ADVR has not/or will not use the results (as specified in the 30-patient Protocol).
IMHO....they will file an INDA with specific data from the 1st two rounds of testing!
The abstract will state what it
stated when submitted. The poster will (or should) likely contain an update
on the numbers. This is a common practice. I'll contact the company to
request that they post the pdf of their poster on the website at least when
the conference is over. If poster is not updated then we have additional
cause for concern in my opinion.
LOL...Allen, are you PMS'ing again.
Go back and read what I wrote in my post concerning the ASCO Abstract. No where did I ever say the preliminary results on the 15 patients WAS COMPLETE AND FINAL DATA. No where did I ever say the results from 23 patients WOULD BE COMPLETE AND FINAL DATA.
What I did say (IMHO) was if Hawkins stated the INDA would be filed in June/July (assuming of course, she meant the year 2004) THEN, THERE IS NO WAY IN HECK THE RESULTS FROM "all" THE 30 PATIENTS WOULD BE USED IN THE INDA. THERE JUST ISN'T ENOUGH TIME TO "recruit and test" the remaining PATIENTS IN THE PROTOCOL.
GEEZ......try some Midol for those cramps and bloated feeling you are experiencing.
January 2004: 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,
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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Four very encouraging comments from
the firm of Wilner, D'olimipio, Guarino and Hirshman.
"We have taken the unusual step of publicizing these preliminary results, despite the small population of patients, because of the apparent strong clinical results demonstrated, even in this short course treatment protocol, by AVR118 in these very ill patients," said Eli Wilner, Chairman of the Board of ADVR. "If the continuation of the study confirms these preliminary findings, the value of AVR118 in treating body wasting in AIDS patients will merit much broader scientific analysis in a large study of AIDS patients."
"These preliminary results are very encouraging because a positive clinical effect was seen in virtually all patients following initiation of treatment with AVR118, even at the lowest dosage," said James D'Olimpio, M.D., Director of the North Shore University Hospital's Supportive Oncology and Palliative Care Service, and a member of ADVR's Scientific Advisory Board. "The study design and quality of data is worthy of a presentation at an appropriate international scientific meeting. I would encourage the investigators to prepare an abstract once the statistical analysis of the data set is completed so that these promising preliminary results can be shared with the global scientific community." Dr. D'Olimpio has done extensive research on cachexia, particularly in cancer patients.
"The preliminary results demonstrate the potential utility of AVR118 in this group of patients," said Richard A. Guarino, M.D., ADVR's clinical and regulatory advisor.
"These preliminary results in cachectic AIDS patients are encouraging, and I eagerly await possible confirmation of our preliminary results once all 30 patients have completed the trial," said Shalom Z. Hirschman, M.D., ADVR's Chief Scientist. "These results garnered midway through the clinical trial appear to validate our expectations of the clinical activity of the unique immunomodulator AVR118."
The comments were made in the Nov 10,2003 PR. AVR 118s time to show and tell. Just kidding about the firm part.
(Voluntary Disclosure: Position- Long)
In the past, it has almost always
been the case where a large positive run-up happened prior to an ADVR
That such a trading pattern has not happened has bothersome potentials for those looking and praying for PPS increases.
I am surprised that there has not even been a blip on the radar for this.
For you longs, let's hope the Israeli trials produce something more than what we are seeing here.
However, I am assuming this presentation is the data prelude to the results all expect to see out of Israel - and if this unveiling here tomorrow doesn't light a fire, there is no reason to believe the OFFICIAL trial results will do any different.
Once again, only an an agreement with a potential partner is going to move your ADVR investment portfolio along. Also, if as Hawkins says, they are going to instigate further testing - look for another financial crisis as - even with Dicke's cash - costs will rise higher than ever before.
The revolving catch 22 remains for ADVR so long as they do not have a partner.
ASCO: Big Pharma Could Hog
Matthew Herper, 06.03.04
The annual meeting of the American Society for Clinical Oncology, the biggest cancer confab of the year, starts Saturday. Investors should watch out for surprises outside of the field of closely watched biotechs that are already hogging the spotlight.
The biggest surprise of the meeting may not be how well drugs do or don't work, but who is developing them. Big drug companies may play a large role this year as those such as Pfizer (nyse: PFE - news - people ) and Novartis (nyse: NVS - news - people ) see their investments in more newfangled drugs pay off and Aventis (nyse: AVE - news - people ) and Eli Lilly (nyse: LLY - news - people ) highlight the benefits of more traditional chemotherapy.
Aventis' Taxotere and Lilly's Gemzar are both chemotherapy agents that have been on the market for years. But last month, both received approval from the Food and Drug Administration for treating new types of cancer. Taxotere was approved for prostate cancer, and Gemzar was approved for breast cancer.
Targeted cancer drugs such as Genentech's (nyse: DNA - news - people ) Avastin tend to get lots of attention, because they fulfill long-held hopes that a smart bomb approach might banish cancer without chemotherapy's side effects. But that doesn't change the reality that some chemotherapy drugs produce stunning results. To benchmark oncologists' desire to use Avastin, some Wall Street analysts are using a chemotherapy, Eloxatin from Sanofi-Synthelabo (nyse: SNY - news - people ), as their benchmark.
"It's been twenty years since famous names had their faces on the cover of Time magazine saying this would be the magic bullet," says Norman Wolmark Chairman of Oncology at Allegheny General Hospital in Pittsburgh and an investigator in a trial testing Eloxatan. "Unfortunately, in the excitement the incremental gains being made with chemotherapy are overshadowed."
Just because a cancer drug shows great results at ASCO doesn't guarantee its future. Take Millennium Pharmaceuticals (nasdaq: MLNM - news - people ), which makes the multiple myeloma drug Velcade. Analysts are watching for signs that Velcade can work in other diseases, and a trial in lung cancer could give them new information. "That's a clue to where else this drug will go," says Michael King, an analyst at Banc of America Securities. For many companies, new data will determine whether their stocks can rise despite already heady valuations. Saleswise, so far, King labels Velcade a "disappointment." Banc of America has done various types of banking for Millennium.
There is still great promise in targeted cancer drugs. "In the year 2004, chemotherapy remains a mainstay," says Susan Hellmann, president of product development at Genentech. "Lance Armstrong was cured with chemotherapy." But Hellman, who worked on the cancer drug Taxol before coming to Genentech, emphasizes that once most kinds of cancer spread to other parts of the body, tumors are still incurable. She sees targeted therapy as the best way of starting to destroy tumors with fewer side effects. She says: "I really believe there will be a day when we don't use chemotherapy.
Since last year's meeting, shares of Genentech have nearly doubled on a split-adjusted basis, and those of ImClone Systems (nasdaq: IMCL - news - people ) are up 150%. But investors may want to consider how much new data can push up these medicines. Alternatively, they might want to look for small companies that are still ignored.
But it's also worth keeping in mind that big drug companies tend to be less eager to disclose their data than small ones. Pfizer's SU11248 and Novartis' PTK-787 are both cancer pills that are just becoming visible now. If they work, that could surprise many biotech competitors.
I agree with you as you and i have
seen in the past the movement prior was always a run up... no with nothing
it could mean 1 of 2 things... there is a true silence for a golden hit and
they have squashed the corporate leak with the changing of the guard and
others. Or 2- no one really gives a #### because this is old hat as we have
seen in the past and people are truly waiting for the right set and i do
mean set of announcements 1 after the other and limelight type of PR... to
get this stock off the ground ... the best you will see is the typical day
trade to make a few pennies on the play....
that is it.....MHO
bernie and rick
for once we'll know within a week answer to many questions.....what a long strange trip it's been!
The New H.I.V. Test Offers Quicker
Results, but the Same Agony
By DAVID TULLER
June 1, 2004, NYTimes
Nothing I had done in the two years since my previous negative H.I.V. test led me to think I would come up positive this time around. But I am a 47-year-old noncelibate gay man in San Francisco. And like many of my friends, I try to get checked every now and then as a psychological reminder of the payoff I get from staying safe.
The one-week gap between getting blood drawn and receiving the results has always been harrowing. The wait guarantees a slew of restless nights, but it also focuses your mind and forces you to confront your fears and your past.
You replay your recent sex life on the video screen of your mind, pausing to examine certain moments in excruciating detail. You drive yourself nuts by concocting images of far-fetched but theoretically possible routes of infection. You stumble through the five stages of grief described by Elisabeth Kübler-Ross. When the result comes back negative, the wave of relief helps to quell, at least for a while, the chattering in your brain.
So I wondered how it would feel this time taking the new rapid H.I.V. blood test, which crams the one-week cycle into 40 or so minutes. The Food and Drug Administration approved this new test technology in November 2002, and more recently approved a test that uses saliva instead of blood.
About a third of those who take publicly financed standard H.I.V. tests fail to return for their results, according to government figures. And because many of these tests are anonymous, contacting those who are infected is not an option. Health officials hope the growing use of the rapid test will help to increase the numbers of H.I.V.-positive people who know they have the virus.
At my local health clinic, the H.I.V. test counselor - eager, earnest, spike-haired - looks about 13 but tells me he is 33. He has lost a partner to AIDS, as have I.
He has a pretty tough job. Notwithstanding the remarkable treatment advances of recent years, I would not relish having to inform frightened young men and women that they are infected with a lethal virus.
He explains that they need just a pinprick of blood from my fingertip, not the vial from my vein that the standard test requires. That is a real blessing for needlephobes like me. He also tells me that a negative result is conclusive, but that if it is positive, he will have to draw blood for a test to confirm.
He sends me next door, where a cheerful health attendant jabs my finger. When I return, he begins the usual battery of questions about my sex life.
Condoms? Always. Any broken ones? No. How many partners in the last year? Enough. Positive partners that you know of? Yes. Women? None. Sex under the influence of alcohol? Rarely.
We discuss the relative risks of a.n.a.l sex (high) and oral sex (very, very low).
I know that one answer to the epidemic for a single gay man is to avoid sex altogether. But I treasure human touch, so celibacy does not feel like a viable option to me.
I could also, I suppose, limit my contacts to H.I.V.-negative men. Straight people recommend that strategy as if it is a no-brainer. But they are not confronting a dating pool so full of potential risk. In my city, lots of the gay men I meet are H.I.V.-positive. Thanks to the current crop of medications, many have successfully kept illness at bay and continue to lead full lives.
To reject such a huge number of people out of hand feels wrong, like rejecting someone for having cancer or diabetes. That sort of discrimination, however understandable, long ago earned a name in the gay community: viral apartheid.
I certainly know men who have come up positive in recent years. Broken condoms. Slip-ups. Impulsive acts fueled by lust and drugs and a hunger for connection. I have known the pain that brought them there - the death of friends and lovers, the loneliness. I see how getting infected might bring some flicker of relief; it's done, the fight's over, you can relax now.
I have found myself so tempted, after so many years of self-restraint, to chuck it all and break the bounds.
But I'm me, so I don't. Because I know that then the tests and drugs and treatment decisions would start for real, and that they would stretch before me without end.
If you are gay, and you live in San Francisco, these anxieties fade in and out of consciousness. But the week of waiting to learn your fate always delivered them in a concentrated dose. This time around, there is little chance for them to gather intensity and power. And the relief, when it comes, feels like an anticlimax.
My 13-year-old counselor goes next door to retrieve my results. My chest tightens. He comes back in. He's grinning. "Well, it's negative, like you thought," he says.
My body sags. I smile. I pull my jacket on, stand up, thank him and pass through the waiting room, where several men sit and fidget. I am still in the clear, but it is likely that someone else will be getting bad news tonight.
mzfbc, don't be in such a rush.
Today is just accumulation, don't expect a move up. Tomorrow late afternoon,
you watch the ASK drop as MM's really don't want to be selling ADVR at .14
ahead of ASCO.
Not saying to the moon, but we'll see a good rise monday morning... looking for .18.
Traders will start buying late friday... go through this every year.
LETTER FROM THE CEO
To our Valued Shareholders:
As the new CEO of Advanced Viral Research Corp., I am delighted to be on board and am excited about the future. Although we have recently filed our 10K with the SEC, I wanted to reach out to you - our shareholders - in a more personal way. Our shareholders are the backbone of our Company and we thank you for your support.
As part of a new, open communications plan, I wanted to share some of our future plans and upcoming events with you.
Since starting in mid-February, I have been focused on major business initiatives and strategic direction. We remain dedicated to our mission of introducing AVR118 to patients and are taking all of the necessary steps to make this possible. It is my experience that a solid strategic direction is critical to the success of any company. To this end, I am developing a cogent and focused strategy with very clear objectives. It is my personal commitment, as well as that of the Company, to deliver on those objectives in a timely fashion.
As you know, drug development is a long and costly endeavor that is done under the auspices of the Food and Drug Administration (FDA) in the United States. I have spent the last two decades in drug development and know first-hand what it takes to get a product approved by the FDA for marketing. The only way forward for Advanced Viral is to remain focused on conducting high-quality clinical trials on AVR118 in the United States in accordance with FDA regulations. It is paramount that we lay a solid foundation in working with the FDA and conduct clinical trials in accordance with Good Clinical Practices. We will also be paying a great deal of attention to other, relevant operations which are equally important in drug development such as quality control, quality assurance, and manufacturing.
It is our hope that the clinical trials in Israel will help facilitate the trials in the United States; however, it is important to point out that any clinical trial is unpredictable and there can be no assurances as to start date, enrollment rate and completion date. While data cannot be disclosed on an ongoing basis due to the need for data verification and database validation, we are encouraged by the early findings in our Israeli trials and anticipate completion by the end of the second quarter this year.
We recognize that regular, clear and accurate communication is essential. We have some exciting upcoming events, which include:
Presentation at ASCO: We will be presenting a poster at The American Society of Clinical Oncology's (ASCO) 40th Annual Meeting in June of this year. ASCO is the world's leading professional organization representing physicians who treat people with cancer and we are thrilled to be invited to such a prestigious conference. As you probably are aware, any information regarding the presentation is under embargo by ASCO until the day of the presentation.
«Meet the CEO» Sessions: I anticipate setting up a road show to meet with investors personally in May in Boston, New York and Florida should there be sufficient interest from our shareholders. Please e-mail Veronica Welch at email@example.com if you are interested in attending. I look forward to meeting with as many investors as possible.
Open-house: We will host an open-house event at our corporate headquarters in Yonkers, NY in July. Please contact Maria Marino at firstname.lastname@example.org for a reservation.
Quarterly updates: We will be giving quarterly updates either by conference call or by letters such as this one.
E-Communication: We are revamping our web site to make it more user-friendly and informative. We will also introduce an e-mail system whereby investors can automatically receive press releases and updates via e-mail. An overhaul will also be done for our investor relations and media kits.
Media: We continue to speak with the national media on a daily basis regarding the benefits of AVR118. This campaign will be stepped up during the second half of the year.
On a final note, the values with which I will drive the Company are integrity and honesty. I appreciate your continued support of our company and, most of all, thank the employees for their dedication and tenacity. You can rest assured that we are working aggressively to meet all of our strategic objectives. Please continue to refer to our web site for investor updates and press releases.
Elma S. Hawkins, PhD, MBA
President and Chief Executive Officer
Note: The information contained herein contains forward-looking statements that involve risks associated with clinical development, regulatory approvals, including application to the FDA, product commercialization and other risks described from time to time in the SEC reports filed by the Company. AVR118 is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries. There is no assurance that the Company will be able to secure the financing necessary to complete the clinical trials of AVR118. The Company undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.