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ADVR Presented Final Results of its Phase I/II Clinical Trial of AVR118 in Patients with AIDS at the 2005 Annual Assembly of the AAHPM and HPNA.


YONKERS, N.Y. -- Advanced Viral Research Corp. (OTC Bulletin Board: ADVR ADVR - Association of Directors of Volunteer Resources (Canada)) announced today that the Company presented final results of its Phase I/II clinical trial of AVR118 in patients with AIDS at the 2005 Annual Assembly of the American Academy of Hospice and Palliative Medicine (AAHPM AAHPM - American Academy of Hospice and Palliative Medicine) and Hospice and Palliative Nurses Association (HPNA) in New Orleans, LA.

The presentation "Efficacious Reversal of AIDS Related Anorexia/Cachexia
cachexia hypophysiopri´va  the train of symptoms resulting from total deprivation of pituitary function, including loss of sexual function, bradycardia, hypothermia, and coma.
malarial cachexia  the physical signs resulting from antecedent attacks of severe malaria, including anemia, sallow skin, yellow sclera, splenomegaly, hepatomegaly, and, in children, retardation of growth and puberty.
 Syndrome: Final Results of a Phase I/II Study Using a Novel Peptide-Nucleic Acid Complex" given by James T. D'Olimpio, M.D. on Saturday, January 22nd, 2005, showed the results of a Phase I/II clinical trial conducted in Israel at the Kaplan Medical Center. A total of 30 cachectic cachectic /ca·chec·tic/ (kah-kek´tik) pertaining to or characterized by cachexia.

ca·chec·tic (k-kk
 patients with AIDS wasting were enrolled in the trial. Three groups of 10 patients each received AVR118 subcutaneously at a dose of 0.4, 2.0 or 4.0 ml/day for 28 days (six days/week).

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 thickness were measured for all patients. Spontaneous patient comments regarding quality of life parameters, including improvement in mood, appetite, alertness, activities of daily living, malaise, myalgia
epidemic myalgia  see under pleurodynia.


my·al·gia (m-lj
 and power/energy were recorded. Adverse events were monitored.

All dose groups showed an improvement in weight, strength, BMI, and calf circumference, with more significant improvements in the two higher dose levels. The patients at the highest dose appeared to have the most benefit. Twenty-nine of the 30 patients had anorexia before beginning treatment with AVR118. Anorexia resolved in a dose-related fashion, with all patients at the highest dose becoming anorexia-free after three weeks of treatment. Benefit appeared to continue beyond the end of dosing, with all patients being free from anorexia four weeks after receiving the last dose of AVR118.

Spontaneous patient comments were recorded and reflect widespread, dose-related improvements in quality of life. Many patients reported improvement in mood, decreased fatigue, and increase in activity level. More benefits were reported by patients on the highest dose level than at the lower two dose levels.

AVR118 continues to show a favorable safety profile. Adverse events reported did not appear to be drug related, and there did not appear to be any relationship between the dose level and the appearance of any adverse event.

"We are extremely encouraged that AVR118 continues to demonstrate evidence of unique patient benefits. Drug approval requires evidence of clinical benefit, and we are excited to note that all patients reported improvement or resolution of one or more AIDS-related complaints," said Dr. Elma Hawkins, President and CEO of Advanced Viral Research Corp. "The study data also show a favorable safety profile and no apparent drug-related adverse events."

Results Reported - AIDS:

0.4 ml dose

--Nine patients were anorexia-free after four weeks of treatment.

--Half of the patients reported increased daily activity; 40% reported improvement in mood.

2.0 ml dose

--All patients were anorexia-free after four weeks of treatment.

--All patients had an increase of fat percentage after treatment and this was sustained in the majority of patients.

--Forty percent of the patients reported an improvement in their mood and increased daily activities.

4.0 ml dose

--All patients were anorexia-free after three weeks of treatment. It is important to note that two patients had more severe degrees of anorexia prior to beginning therapy with AVR118 which resolved.

--Patients in this cohort increased their average weight by over 2.2 pounds over four weeks of treatment.

--All patients showed an increase in body fat.

--Sixty percent of patients reported an improvement in mood and increase in daily activity.

--Eighty percent of patients reported decreased fatigue and 70% reported improvement in energy.

"At this meeting, we presented the remarkable efficacy and safety profile demonstrated by AVR118 in this clinical trial," said Dr. D'Olimpio, who presented the paper. "We stressed that patients spontaneously reported evidence of efficacy at all dose levels during the trial, including at the 0.4 ml dose. These reports included improved mood, less fatigue, and the ability to perform more activities of daily living, and represent a significant change in the patients' quality of life. We received a great deal of enthusiasm from other physicians at the meeting."

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 those which occur in patients with rheumatoid arthritis.

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. For further information regarding Advanced Viral Research Corp., please visit our website at www.adviral.com.

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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Publication:Business Wire
Geographic Code:1USA
Date:Jan 24, 2005
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