Pfizer (PFE) reported that maraviroc produced an undetectable level of virus in twice as many patients as an optimized regimen. Maraviroc was given as an adjunct to the optimized regimen and compared to the regimen alone. Also, in maraviroc patients, the level of CD4 cells was almost twice as high as the placebo group.
Maraviroc was given to patients with CCR5 tropic HIV, meaning that the virus attacks patients through the CCR5 receptor. Rather than fighting the presence of HIV in white blood cells, as is the mechanism of current therapies, maraviroc seeks to prevent the virus from entering cells. Data came at the 24-week mark. Maraviroc goes up in front of an FDA advisory panel in April.
Merck (MRK) reported that Isentress (raltegravir), an oral integrase inhibitor, significantly reduced viral load as opposed to an optimized background therapy. Isentress was given as an adjunct to the optimized background therapy. An integrase inhibitor interferes with the ability of the HIV virus to integrate into the genetic material of human cells.
In the Isentress group, 73% of the patients achieved a viral load of less than 400 copies/mL, against 37% in the control arm. The drug was administered to patients who had failed previous antiretroviral therapies and were resistant to at least one drug in the three classes of oral antiretrovirals. The data came at the 16-week benchmark.
Gilead (GILD) said that its new oral HIV integrase inhibitor was outperforming a boosted protease inhibitor. The data comes from 24-week data in a Phase II trial that is testing three different dosing levels of GS 9137 (elvitegravir). Both GS 9137 and the boosted protease inhibitor were given along with an optimized background regimen. The endpoint of the trial is to prove non-inferiority.
Roche (OTCQX:RHHBY) and Trimeris (TRMS) said that Fuzeon produced an undetectable level of HIV in 98% of the recipients. Fuzeon was given along with Merck’s Isentress (raltegravir), the novel investigational integrase inhibitor reported above, and an active boosted protease inhibitor. The trial defined “undetectable” at 400 copies/mL, which is less stringent than the international standard of 40 copies/mL.
Idenix Pharma (IDIX) reported positive pre-clinical data of two novel non-nucleoside reverse transcriptase inhibitors [NNRTIs] for HIV-1 infection. The two compounds, IDX899 and IDX989, demonstrated potent and selective activity in vitro. Because a NNRTI-resistant virus is emerging rapidly, the goal is to find new NNRTIs that can overcome the resistance.
Pharmion (PHRM) said European regulators accepted its filing for approval of Thalidomide Pharmion as a treatment for multiple myeloma. Pharmion licensed the ex-U.S., ex-Japan rights to the drug from Celgene (CELG).
Novavax (NVAX) licensed IP from U. Mass for a new virus-like particle technology, using paramyxoviruses to build a new VLP vaccine. Novavax said the new technology will complement the methods it used to create potential VLP vaccines for flu. Terms were not disclosed.
Idenix Pharma (IDIX) won approval in China for Sebivo (telbivudine) for chronic hepatitis B. The drug was approved in October 2006 for CHB in adult patients with evidence of viral replication and active liver disease. In the U.S., the drug is called Tyzeka. Novartis (NVS) is co-promoting the drug.
Biotech closed out a down week with another negative session. The Centient Biotech 200™ fell 44 points to 3822, a loss of 1.13%. For the week, biotech is down 232 points or almost 6%.