Ohr Pharmaceutical Inc. (OTCBB: OHRP) is developing OHR/AVR118 for treatment of cachexia based on technology acquired earlier this year from Advanced Viral Research Corp. OHR/AVR118 has shown excellent therapeutic efficacy and safety in human clinical trials in over 100 patients with applications for cachexia in Cancer and AIDS patients, as well as Rheumatoid Arthritis. OHR/AVR118 is a unique immunomodulator that affects the synthesis of chemokines and cytokines. Its main action is anti-inflammatory through the inhibition and modulation of cellular pro-inflammatory chemokine and cytokine synthesis, especially tumor necrosis factor-alpha (TNF-alpha). Moreover, the drug acts to maintain immune homeostasis. It prevents the very destructive and toxic cytokine showers that result from certain viral infections such as influenza and many cancers, including the chemotherapeutic drugs and radiotherapy given to shrink tumors. As would be expected based on its molecular immunomodulating properties and mechanism of action, Ohr118 has also shown efficacy in the treatment of the important auto-immune disease Rheumatoid Arthritis.

In an early Phase 2 open-label, dose-escalation trial of 32 cachecic patients suffering with AIDS or cancer, OHR/AVR118 was administered subcutaneously at doses of 0.4 to 4 ml/day for 28 days (6 days/week). 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, with the higher dosing cohorts exhibiting an average positive weight gain. Patients in the highest dosing cohort increased their average weight by 2.2 pounds over four weeks of treatment and this effect continued through the following four weeks at which point the average weight had increased by 2.6 pounds over baseline. All patients in this cohort also showed an increase in fat percentage which was sustained after treatment discontinuation in all patients. All patients reported an increase in daily activity and 80 percent of the patients reported decreased fatigue. Spontaneous patient comments reflect widespread dose-related improvements in Quality of Life (QOL). OHR/AVR118 showed a very favorable safety profile with no major adverse effects in the trial, building upon its strong safety profile in other human and animal studies.

An earlier randomized double blind clinical study enrolled 43 cachecic HIV-infected adults naive to anti-retroviral therapy. A total of 21 patients received OHR/AVR118, and 22 patients received a placebo. Dosing was two 1ml subcutaneous injections daily on the first 14 days, followed by one daily 1ml dose on days 22-28, 36-42 and 50-56. The follow up period lasted until day 120. At the end of the follow up period, there was a statistically significant increase in CD4 positive cell counts (p=.014) in the OHR/AVR118 treated patients. The treated patients experienced a mean weight increase (p=.003) while the placebo group experienced a mean weight loss. No toxic effects were observed in any of the patients who received OHR/AVR118. There was a trend towards higher CD8 cell counts, lower viral loads and fewer opportunistic infections in the OHR/AVR118 treated group.

Recognizing the tremendous potential for OHR/AVR118 to become the standard of care for Cancer and AIDS patients suffering from Cachexia, Ohr is dedicated to continue the development of OHR/AVR118. Currently, OHR/AVR118 is in an open-label late Phase 2 trial being conducted at McGill University for the treatment of Cachexia in Cancer patients.

Source
Ohr Pharmaceutical, Inc.

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