GAITHERSBURG, MD--(Marketwire - November 04, 2011) - Functional Genetics announced that it has successfully completed a first-in-human Phase 1A clinical study of FGI-101-1A6, a fully-human, first in class, broad-spectrum antiviral antibody targeting the host protein TSG101. The localization of TSG101 on the cell surface is unique to cells infected with viruses such as HIV, influenza, and poxviruses and is independent of genetic, seasonal or drug resistance changes in the virus. This cell surface expression of TSG101 enables FGI-101-1A6 to target and eliminate only the infected cell.
The Phase 1A clinical trial was a single-center, double-blind, placebo-controlled, single-dose escalation study designed to demonstrate safety and determine pharmacokinetics of a single dose in healthy adult volunteers. A total of 48 volunteers were enrolled and randomized to 6 dose level cohorts, ranging from 0.0017 mg/kg to 10 mg/kg (36 received FGI-101-1A6, 12 received placebo). Results of this Phase 1A study indicate that FGI-101-1A6, administered as an intravenous infusion in healthy adult volunteers, was well tolerated at all doses and support continued clinical investigation of FGI-101-1A6. Additionally, FGI-101-1A6's long half life is consistent with previously reported estimates for other monoclonal antibodies.
"We are encouraged by the overall safety and PK profile of FGI-101-1A6," stated FGI chief executive officer Michael Goldblatt, Ph.D., "and are actively pursuing the ongoing clinical development of FGI-101-1A6. "We expect to initiate a Phase 2 proof-of-concept study in the near future, exploring FGI-101-1A6 in a suitable infectious disease population."
The TSG101 target is a product of the Company's proprietary Random Homozygous Gene Perturbation (RHGP) target discovery and validation platform, and is essential to the life cycle of many enveloped viruses.
FGI-101-1A6 is a fully human IgG1 antibody targeting a universally conserved epitope of TSG-101. The binding of the antibodies to the target trigger the host's immune system to eliminate the infected cells and the virus it contains. Because the TSG101 target is only present when the cell is infected with a virus, the effectiveness of FGI-101-1A6 is highly specific with no collateral impact to healthy tissues.
FGI's novel approach is based on the use of its proprietary Random Homozygous Gene Perturbation (RHGP) technology which is applicable to any disease that can be modeled. RHGP identifies host (cellular) targets which, in virus-infected cells, are functionally altered. Using animal models the Company has demonstrated that these changes in host target function provide opportunities to selectively target unrelated virus types by a single therapeutic, without harming normal cells. Host targeting also minimizes the likelihood that drug resistant variants will arise. In addition to TSG101, the Company has identified two other novel targets for which lead candidate selection is underway.
About Functional Genetics, Inc.
Functional Genetics, Inc. (FGI) is a privately-held, clinical-stage biotechnology company, headquartered in Gaithersburg, MD, that uses innovative science to develop better medicines to treat or prevent infectious diseases and cancer. The Company's unique scientific approaches have allowed it to develop novel antiviral drugs that demonstrate beneficial activity against a broad-spectrum of different viruses, including HIV, influenza, HCV and bio-threat pathogens. For more information, visit Functional Genetics' website at www.functional-genetics.com.
This news release contains forward-looking information. These statements relate to future events or future performance and reflect management's current expectations and assumptions. Such forward-looking statements reflect management's current beliefs and are based on information currently available to management of Functional Genetics, Inc. A number of factors could cause actual events, performance or results to differ materially from the events, performance and results discussed in the forward-looking statements. These forward-looking statements are made as of the date hereof and Functional Genetics, Inc. does not assume any obligation to update or revise them to reflect new events or circumstances.