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Press Release Source: Advanced Viral Research Corp.

ADVR Presented Results of its AVR118 Phase 1/2 Clinical Program at ASCO
Sunday June 6, 2:00 pm ET

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.

 


 

By: Chrisdez
06 Jun 2004, 02:42 PM EDT
Msg. 156021 of 156250
(This msg. is a reply to 156020 by kevtod.)
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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.

 
By: allen_only
06 Jun 2004, 02:54 PM EDT
Msg. 156024 of 156249
(This msg. is a reply to 156018 by aven2002.)
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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.

Allen
 
By: allen_only
06 Jun 2004, 02:56 PM EDT
Msg. 156026 of 156250
(This msg. is a reply to 156020 by kevtod.)
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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
 
By: rarboston
06 Jun 2004, 03:17 PM EDT
Msg. 156033 of 156250
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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?
 
By: mzfbc
06 Jun 2004, 04:07 PM EDT
Msg. 156059 of 156250
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iS IT NOT TRUE THAT WHEN A DRUG IS 30% SUCCSESSFUL
THEY CALL IT A BLOCKBUSTER DRUG?
 
By: oracle_angel
06 Jun 2004, 04:19 PM EDT
Msg. 156061 of 156250
(This msg. is a reply to 156059 by mzfbc.)
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mzfbc, did you like the BUYING after 2.30 friday?

A couple mil hiting the ask before close.

Enjoy the ride up!
 
By: Ourobouros
06 Jun 2004, 05:23 PM EDT
Msg. 156070 of 156250
(This msg. is a reply to 156017 by shaggydogs.)
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Once again, ask, Phase 1/2 under WHOSE auspices??

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."
- - - - -
 
By: Ourobouros
06 Jun 2004, 05:31 PM EDT
Msg. 156076 of 156250
(This msg. is a reply to 156040 by kevtod.)
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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!
 
By: Ourobouros
06 Jun 2004, 05:32 PM EDT
Msg. 156078 of 156249
(This msg. is a reply to 156043 by aven2002.)
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Aven, "DO NOT FATS STORE ENERGY AND FUELS FOR THE BODY!!Then FATS ARE FIRST,MUSCLE's COME FROM THE FATS,SECONDARY!!"

You don't have a clue, do you?

 
By: allen_only
06 Jun 2004, 06:09 PM EDT
Msg. 156096 of 156250
(This msg. is a reply to 156095 by lovingitall0.)
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lov, I hope ADVR soars tomorrow and several here sell and move on.

You ARE the board--you keep doing what you do
 
By: hanbury0
06 Jun 2004, 07:17 PM EDT
Msg. 156114 of 156250
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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.

 
By: lovingitall0
06 Jun 2004, 07:54 PM EDT
Msg. 156116 of 156250
(This msg. is a reply to 156115 by firehirshman.)
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"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!

Luv
 
By: Ourobouros
06 Jun 2004, 08:10 PM EDT
Msg. 156117 of 156250
(This msg. is a reply to 156087 by kevtod.)
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"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 frame."

----------------

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)

 
By: Ourobouros
06 Jun 2004, 08:25 PM EDT
Msg. 156118 of 156250
(This msg. is a reply to 156104 by SPARKR.)
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Would you care to tell me WHAT "Phase 1/2" as described by ANY legitimate testing agency that falls under/within.

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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View Replies
 
By: Ourobouros
06 Jun 2004, 08:28 PM EDT
Msg. 156119 of 156250
(This msg. is a reply to 156115 by firehirshman.)
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"100% efficacy !!!"

Towards what???

Without double blind testing, these results are basically anecdotal.
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By: firehirshman
06 Jun 2004, 09:07 PM EDT
Msg. 156120 of 156249
(This msg. is a reply to 156119 by Ourobouros.)
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Ouro: Wait. Watch the news. MORE TO COME !
 
By: SPARKR
06 Jun 2004, 09:23 PM EDT
Msg. 156123 of 156249
(This msg. is a reply to 156117 by Ourobouros.)
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Ourobouros

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 ?

SPARKR
 
By: Chrisdez
06 Jun 2004, 09:36 PM EDT
Msg. 156126 of 156250
(This msg. is a reply to 156023 by kevtod.)
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good point, however, first things first for anorexics.


 
By: SPARKR
06 Jun 2004, 10:00 PM EDT
Msg. 156128 of 156250
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FROM : LETTER FROM THE CEO

April 2004

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 mariag@adviral.com 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.

LOL

SPARKR