ADVR Presented Results of its AVR118 Phase 1/2 Clinical
Program at ASCO
All Patients with Anorexia at Entry Regained Appetite
YONKERS, N.Y., June 6 /PRNewswire-FirstCall/ -- Advanced Viral Research Corp. (OTC Bulletin Board: ADVR - News) announced today that the company presented interim results of its Phase 1/2 clinical program with its flagship product, AVR118, at The American Society of Clinical Oncology's (ASCO) 40th Annual Meeting in New Orleans, LA.
The presentation "Anti-Cachectic Effects of a Novel Peptide Nucleic Acid Complex: Preliminary Results of a Phase1/2 Clinical Trial," given by James T. D'Olimpio M.D, showed the results of Phase 1/2 clinical trials conducted in Israel. A total of 25 cachectic patients (patients with cancer cachexia or AIDS wasting) were enrolled in the trials. Ten patients with advanced AIDS and two patients with advanced pancreatic cancer received AVR118 subcutaneously at a dose of 0.4 ml/day for 28 days (6 days/week). Eight AIDS patients received a dose of 2.0 ml/day and five patients received 4.0 ml/day at the same schedule.
All patients were followed for 28 days after treatment was completed. Total weight, body mass index (BMI), fat percentage, strength, calf and arm circumference, and skin fold were measured for all AIDS patients. Spontaneous patient comments regarding quality of life (QOL) parameters, including improvement in mood, appetite, alertness, activities of daily living (ADLs), malaise, myalgia and power/energy were recorded. Adverse events were monitored.
All dose groups showed an increase in weight, strength and fat percentage, with more significant improvements in the two higher dose levels. All patients with anorexia at entry became anorexia-free after three weeks of therapy. Spontaneous patient comments reflect widespread, dose-related improvements in Quality of Life (QOL). AVR118 continues to show a favorable safety profile.
"This trial was designed as a dose-escalation study and we are pleasantly surprised to see such strong data given the relatively short treatment period," said Dr. Elma Hawkins, President and CEO of Advanced Viral Research Corp. "We are very encouraged by the results, most importantly with the resolution of anorexia in all study participants."
Results Reported - AIDS: 0.4 ml dose * All patients were anorexia-free after three weeks of treatment. (One patient did not have anorexia at baseline). * Half of the patients reported increased daily activity. 2 ml dose * All patients were anorexia-free after three weeks of treatment. * At the end of four weeks of treatment the average weight of patients increased by over a pound. * All patients had an increase of fat percentage after treatment and this was sustained in the majority of patients. * Approximately half of the patients reported an improvement in their mood and increased daily activities. 4 ml dose * All patients were anorexia free after three weeks of treatment. It is important to note that 50 percent of patients had Grade Two anorexia at baseline. * Patients in this cohort increased their average weight by 2.2 pounds over four weeks of treatment. This effect continued through the following four weeks at which point the average weight had increased by 2.6 pounds over baseline. * All patients showed an increase in fat percentage which was sustained after treatment discontinuation in all patients. * 100 percent of patients reported an increase in daily activity. * 80 percent of patients reported decreased fatigue. Results Reported - Pancreatic Cancer: * Both patients had improved weight (4% increase) * Improved fat percentage (20% increase) * Improved strength (5 % increase)
ADVR's AVR118 represents a biopolymer that possesses novel immunomodulator activity. This peptide-nucleic acid complex, which to date has demonstrated a very favorable safety profile, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. AVR118 is in clinical trials in Israel for the treatment of cachexia (body wasting) in patients with AIDS.
For further information regarding Advanced Viral Research Corp., please visit our website at http://www.adviral.com. Advanced Viral Research Corp., based in Yonkers, New York, is a biopharmaceutical firm dedicated to improving patients' lives by researching, developing and bringing to market new and effective therapies for viral and other diseases.
Note: This news release 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 (Product R) 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 continue and/or complete the clinical trials of AVR118 or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company or that if completed, clinical trials performed outside the United States will assist the Company in obtaining FDA or other regulatory approval. 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.
Contact: Ronnie Welch or Kelly Cinelli CWR & Partners 508/222-4802
Source: Advanced Viral Research Corp.
Pleased to see progress from 15 to
25 reported. Can only hope James D. is using his corporate card to wine and
dine his colleagues at the meeting. I expect it to gap up.
The may be a blockbuster hidden
here...Take note of the
PANCREATIC PATIENTS --PEOPLE THAT IS HUGE
Holy cow !
I want to know more about this.
yes but its still too early -advr
NEEDS TO CONDUCT A LARGE STUDY,
THE PANCREATIC IS AWESOME
I NEVER EVER EVEN THOUGHT ABOUT THIS INDICATION
Not to burst the inflated bubbles
here, but since there was no placebo....wouldn't all patients gain weight
due to other variables in there treatment? Nutritional counselling?
nutritional supplements? HIV and/or cancer meds working? Placebo effect?
iS IT NOT TRUE THAT WHEN A DRUG IS
THEY CALL IT A BLOCKBUSTER DRUG?
mzfbc, did you like the BUYING
after 2.30 friday?
A couple mil hiting the ask before close.
Enjoy the ride up!
Once again, ask, Phase 1/2 under
Without mentioning this, the company releases PRs that are misleading.
The way it is phrased it implies and makes one believe this is under the guideline of the United States FDA - which I believe it is NOT!!!
To me, this is exactly what is wrong with this company...they print only half the truth - and only the part they want people to see.
Of course in small print we see::
"Note: This news release 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 (Product R) 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 continue and/or complete the clinical trials of AVR118 or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company or that if completed, clinical trials performed outside the United States will assist the Company in obtaining FDA or other regulatory approval. 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."
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To me these results are
considerably less than stellar.
If these results do not attract a partner, we are in the same old same old ship we set sail on!
Get real folks!
Aven, "DO NOT FATS STORE ENERGY AND
FUELS FOR THE BODY!!Then FATS ARE FIRST,MUSCLE's COME FROM THE
You don't have a clue, do you?
lov, I hope ADVR soars tomorrow and
several here sell and move on.
You ARE the board--you keep doing what you do
The exposure ADVR gets at The
American Society of Clinical Oncology's (ASCO) 40th Annual Meeting in New
Orleans will definitely gain new investors and I hope several bio-tech
companies like what they herd. This is very exciting news.
"Spontaneous patient comments
reflect widespread, dose-related improvements in Quality of Life (QOL).
AVR118 continues to show a favorable safety profile."
We're looking goooooood!
"From all appearences, the Israeli
Phase I/II trials are completed. Now, we will wait for the results to be
fully tabulated & extrapolated to the extent possible to produce statistical
significance.....Perhaps to be completed by the September - December time
In addition, this release of the ASCO presentation pretty much trumps any news news from any further test results from Israel in terms of further price spikes.
Now the boat ADVR shareholders are in is one in which ALL pending news anticipated has been played out. Soon as this possible PPS spike in the next few days has ended, we should expect a declining PPS with no new anticipatory events.
In this case, watch for many to bail at the spike rise - if there is one.
This is a sorry state right now for ADVR.
They better have really important news AND SOON!!
(Voluntary Disclosure: ST Rating- Strong Sell; LT Rating- Strong Sell)
Would you care to tell me WHAT
"Phase 1/2" as described by ANY legitimate testing agency that falls
Basically when someone talks about Phase I, II, or III in terms of drug testing, it is almost always assumed they are talking about the Phase testing under the US FDA.
This referral to "Phase 1/2" leaves me totally clueless under whose auspices the testing was done and what the phase represent. There is no double blinded studies, no placebo effect taken into account, no accounting as to what other drugs and remedies were being applied during the administration of AVR118. For all we know they had an angelic nurse giving the doses and it was her loving touch that caused them to feel better.
These tests in Israel - mostly because they are NOT remarkable - fall into the anecdotal variety...and ADVR once again has yet to have ANY responsible and meaningful test results that ANY scientist can bank on.
Let alone a partner.
I'm sorry that what I see is different than what you see.
But answer me this one single question - what does "Phase 1/2" refer to in their PR??
(As an addendum, had ADVR gone ahead and continued the PHASE II testing that WAS approved by the US FDA and had today's PR said that PHSE II testing was complete and the results were good - you WOULD see a huge market bounce - this PR is fluff)
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"100% efficacy !!!"
Without double blind testing, these results are basically anecdotal.
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Ouro: Wait. Watch the news. MORE TO
Again , statements you make are false and condradict the written words contained in the Company's PR today .
Please substantiate your statement : "From all appearences, the Israeli Phase I/II trials are completed" .
Today's PR clearly says "preliminary results" of a Phase 1/2 clinical trial being conducted in Israel .
READ THE PR CAREFULLY....IT'S ALL THERE FOR YOU.
The Company has clearly represented the results in today's PR to be "INTERIM RESULTS" .
IMO , the inference "interim results" has : is that further testing results will follow the interim results until completion of the Phase 1/2 clinical trial which will yield "final results" of all on-going testing in Israel in either the 2Q or 3Q as already stated by mgmt.
As far as : " all pending news anticipated has been played out " ,
Hawkins has already stated her goal for an IND submission and to use the Israeli Phase 1/2 clinical trial results to present to the FDA .
Today's results are and should be CLIMACTIC.
Isn't AVR118 the Company's flagship drug ?
As an investor , this news is positive NEWS !
No "real" investor would downplay today's NEWS !
Is this really "a sorry state right now for ADVR" Ourobouros ? Or is this NEWS really bad timing for YOU if you miss the ADVR UPTOWN TRAIN ?
good point, however, first things
first for anorexics.
FROM : LETTER FROM THE CEO
To our Valued Shareholders:
Upcoming events include:
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.
(SECOND HALF OF THE YEAR EXPOSURE: "POST-ASCO" AND "POST-ISRAELI-TRIAL-RESULTS" FOR WHICH, IMO, HAWKINS IS RIGHT-ON!!! GO HAWKINS!!! GO ADVR!!!)
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. (I WILL ATTEND)
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.