GlobeImmune (Louisville) announced encouraging results from the higher dose cohorts of the randomized, placebo-controlled Phase Ib trial evaluating safety, immunogenicity and efficacy of GI-5005 in patients with chronic hepatitis C infection. The data yielded a favorable safety profile with the dose escalation to the highest planned dose without dose limiting toxicity; strong trends for a dose dependent response; viral load reductions in treated patients; viral load reductions were achieved with only 12 weeks of GI-5005 monotherapy with no concurrent anti-viral therapy; biologic-immune activity by converting patients from an immune response profile associated with chronic infection to one similar to patients who clear the virus naturally during the acute phase; and, no placebo patients had near log10 reductions of viral load or demonstrated an immune response.
The mechanism of action for GI-5005 (i.e. immune elimination of infected hepatic cells) may work synergistically in combination with the current or emerging standard of care, which directly inhibits viral replication, to more effectively eradicate hepatitis C virus from the liver. Additionally, this mechanism of action may offer an option for interferon-intolerant or interferon-contraindicated patients as a long term monotherapy.
A randomized Phase II study evaluating GI-5005 plus standard of care (pegylated interferon plus ribavirin versus pegylated interferon plus ribavirin alone) is being initiated in 4Q07 at 50 centers in the US, EU, and India. Long-term GI-5005 salvage therapy will also be examined in this trial in patients who fail to achieve an early virologic response or do not tolerate treatment in the pegylated interferon/ribavirin arm.
The recent $41.2MM Series C close should carry this trial through to its primary endpoints along with clinical advances in GI-4000 in the oncology program for respectable pancreatic cancer. Great news from GlobeImmune indeed and we are anticipating more great news as the Phase II trials progress!