Scientists find new strain of HIV


Gorillas have been found, for the first time, to be a source of HIV.
Previous research had shown the HIV-1 strain, the main source of human infections, with 33m cases worldwide, originated from a virus in chimpanzees.....

this drug seems to bring hope to drug resistant patients, as it is an entry inhibitor with the ability to block both CCR5- and CXCR4-tropic viruses.


Ibalizumab (TMB-355)

http://www.tmbinc.com/?page_id=23


Ibalizumab is a humanized monoclonal antibody (mAb) and a member of an emerging class of HIV therapies known as viral-entry inhibitors. This drug candidate is distinct from other entry inhibitors in that it binds to the CD4 molecule, the primary receptor for HIV infection, thereby interfering with the penetration of the virus into the cell. It is the first entry-blocking humanized mAb to treat HIV/AIDS.

Ibalizumab caught the attention of the scientific community in February 2003, when results from the phase-1, single-dose clinical trial showed a transient but clinically significant reduction in the patients’ viral load. Moreover, it was well tolerated with no evidence of adverse effects on CD4 T-cells of treated subjects unlike the majority of approved drugs for HIV. The U.S. FDA granted Ibalizumab fast track status in October 2003.

The phase-2a clinical trial was successfully completed in 2006, with the results showing a clean safety profile and clear antiviral activity (10-fold reduction in viral load). After the FDA revised the clinical trial guidelines in 2007, TMB devised a new phase-2b protocol which has been submitted and approved by the FDA. A 120-patient trial is well underway that will complete enrollment by 3Q 2009. TaiMed Biologics is concurrently looking into formulating a subcutaneous injection dosage form and a phase 1 human pharmacokinetics bridging study is expected to be completed in the second half of 2010. TMB intends to seek a partner for phase 3 development which is expected to begin by 2011 using multinational clinical sites including Taiwan. The company plans to file BLA for Ibalizumab to the U.S. FDA and to launch the commercial product by the end of 2013.

Phase 2a Study Design and Results

The phase 2a study is a multi-center, randomized, double-blind, placebo-controlled trial to compare safety and efficacy of two doses of Ibalizumab against placebo among 82 treatment-experienced HIV positive patients.

Ibalizumab in combination with OBR (optimized background regimen) resulted in statistically significant viral load reduction compared to placebo plus OBR. Dosing at 10 mg/kg led to a decrease in viral load was associated with a statistically significant and clinically meaningful increase in CD4+ T cells.

Ibalizumab was well tolerated with no infusion-site reactions, no serious adverse events, and no laboratory abnormalities. In addition, good patient adherence to study visits and acceptance of intravenous administration were observed.

Phase 2b Clinical Trial

A 120-patient trial Phase 2b clinical trial is currently ongoing. The primary evaluation of effectiveness will be based on the proportion of patients achieving undetectable viral loads at week 24. Secondary objectives include evaluation of changes in viral load, CD4+ cell counts, TOLVR, PK sensitivity, susceptibility and safety. We anticipate completion of the study in 1H 2010.

Researchers make potential breakthrough in search for aids vaccine

LONDON: Researchers from the International Aids Vaccine Initiative (IAVI) have found two antibodies that kill the HIV virus, which may turn out to be a significant advance in the search for a vaccine against the virus that causes AIDS.
The discovery came from research launched by IAVI in 2006, to find antibodies that neutralise a wide variety of strains of HIV circulating in the world----.

Phase III "RV 144" study in Thailand which combines AIDSVAX with Aventis Pasteur ALVAC-HIV canarypox vector, known as "vCP1521", succeeded in reducing the infection rate in trial with 31.2% effectiveness ("The results were that new infections occurred in 51 of the 8,197 given vaccine and in 74 of the 8,198 who received dummy shots").

"The Thailand Ministry of Public Health conducted the study, which used strains of HIV common in Thailand. Scientists stressed it is not clear whether the vaccine would work against other strains in the United States, Africa or elsewhere."

"The vaccine had no effect on levels of HIV in the blood of those who did become infected, providing 'one of the most important and intriguing findings' of the trial, according to Dr Fauci, giving scientists important clues in identifying whether treatment drugs actually make a difference by giving protection to the immune system."

http://www.telegraph.co.uk/health/healthnews/...n-fight-against-Aids.html
http://www.nytimes.com/2009/09/25/health/research/25aids.html?_r=1

I will avoid the 'red postings' in the future if you prefer. I noticed they are quite common here and I actually thought people appreciated them. But while we are at it: wouldn't it be more appropriate to avoid article duplication instead? You just reported the very same news I posted.