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.

University of Alberta graduate student Jennifer Heys wants to make her message clear: there needs to be more education in Ugandan communities about contraception.

Heys’ research, on HIV-positive individuals and their desire to bear more children, was read by experts from all over the world who gathered last week at the International Conference on Family Planning in Kampala, Uganda.

Heys, who studied at the School of Public Health, spent six months interviewing 421 people who lived in rural and semi-urban communities in Uganda. Of that group 199 were HIV positive.

Heys’ study was to find out if there was a difference between HIV-positive and HIV-negative individuals in regard to their desire to have more children. She found that those who were HIV positive were more likely to want to stop having children.

“The odds of wanting to stop child bearing were 6.25 times greater compared to those who were HIV negative.”

While she was encouraged by these results, Heys says the problem is a lack of education about contraception as most of the people she spoke with were not using what is called “dual protection.” This is done by using two contraceptives, like condoms and Depo-Provera, a hormone injection that prevents pregnancy and needs to be administered every three months.

Heys says of the 421 people, only eight were using two contraceptives and many others relied only on condoms. Heys says this is problematic because, while condoms are important for reducing HIV transmission, she found that when used alone, the condoms were often used incorrectly and, therefore, not a highly effective method of contraception. Some of the interview subjects were not using any contraception at all.

Heys believes the root of the problem is a lack of knowledge about dual protection. She also says there are a lot of misconceptions.

“Some people thought condoms or oral contraceptives could cause cancer. They also had this idea that if you took pills, oral contraceptives, you wouldn’t be able to work in your field as you would be very weak and very tired.”

Heys’ research was published this month in a special supplement of the journal, AIDS.

Source: Carmen Leibel

University of Alberta

The decreased risk of HIV infection in circumcised men cannot be explained
by a reduction in sores from conditions such as herpes, according to
research published in PLoS Medicine.

In further analyses of data from 2 clinical trials including more than
5,000 men in rural Uganda, which had shown that circumcision reduced the
risk
of HIV infection in men by about 60%, Ron Gray of the Johns Hopkins
Bloomberg School of Public Health and colleagues investigated factors
associated
with that reduction in risk. Specifically, they investigated whether
infection with HSV-2, the virus that causes genital herpes, and whether
genital
ulcers of any cause, could account for the lower rates of HIV infection in
the circumcised study participants.

The researchers found that reduction in symptomatic genital ulcer disease
accounted for only about 10% of the protective effect associated with
circumcision, and did not find any consistent role for HSV-2 in
counteracting protection. These results indicate that most of the
reduction in HIV
acquisition provided by male circumcision may be explained by the removal
of vulnerable foreskin tissue containing HIV target cells. They also
suggest
that circumcision reduces genital ulcer disease primarily by reducing the
rate of ulceration due to causes other than herpes, including sores caused
by mild trauma during intercourse.

Funding:
The trials were funded by the US National Institutes of Health
(#U1AI51171), the Bill & Melinda Gates Foundation (#22006.02), and the
Fogarty
International Center (#5D43TW001508 and #D43TW00015). This study was also
supported by the Intramural Research Program of the National Institute of
Allergy and Infectious Diseases, NIH. The funders had no role in study
design, data collection and analysis, decision to publish or preparation
of
this manuscript.

Competing Interests:
The authors have declared that no competing interests exist.

Citation:
“Effects of Genital Ulcer Disease and Herpes Simplex Virus Type 2 on the Efficacy of Male Circumcision for HIV Prevention: Analyses from the Rakai Trials.”
Gray RH, Serwadda D, Tobian AAR, Chen MZ, Makumbi F, et al. (2009)
PLoS Med 6(11): e1000187. doi:10.1371/journal.pmed.1000187

Source
PLoS Medicine