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.

About FGI-101-1A6

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.

About RHGP

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. Functional Genetics, Inc. Phone: +1.240.631.6790 Email: info@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.

• July 20, 2010 -- Diaz L, Mao H, Zhou Y, et al. American Journal of Translational Research

• April 19, 2010 -- Antimicrobial Agents and Chemotherapy, American Society for Microbiology

Gaithersburg, Maryland, USA -- Functional Genetics, Inc. today announced a grant from the Bill & Melinda Gates Foundation to pursue an innovative approach for antibody-based targeting of HIV/AIDS.  Under the terms of the agreement, Functional Genetics will investigate the use of TSG101 antibody targeting of HIV-infected cells for its potential use as a novel HIV vaccine strategy. "This grant from The Bill & Melinda Gates Foundation will greatly assist our mission of developing passive and active immunotherapeutics that target a broad-spectrum of different virus types,” said Michael Goldblatt, Chief Executive Officer of Functional Genetics. "Functional Genetics is committed to developing broad-spectrum, host-oriented therapeutics for the treatment of infectious diseases."

The initiation of this project is another step in Functional Genetics’ ongoing commitment to develop innovative broad-spectrum anti-infectives. This project will continue the development of TSG101 antibody-based, broad-spectrum therapeutics for viral disease. TSG101 was originally discovered using Functional Genetics’ RHGP discovery platform and has been shown to be hijacked in cells that have been infected with many different types of viruses, including HIV and other enveloped viruses. Functional Genetics’ approach of host-based targeting of viral disease is designed to overcome issues that have previously eluded anti-infective therapies, including acquired drug resistance and the relatively narrow spectrum of current therapies.  

About Functional Genetics, Inc.

Functional Genetics, Inc. (FGI) is a privately-held, development stage biotechnology company, headquartered in Gaithersburg, MD. We use innovative science to develop better medicines to treat or prevent infectious diseases and cancer. Our unique scientific approaches have allowed us to develop novel antiviral drugs that demonstrate beneficial activity against a broad-spectrum of different viruses, including HIV, RSV, Influenza, HBV, HCV and bio-threat pathogens, such as Ebola. For more information, visit Functional Genetics’ website at www.functional-genetics.com.

Functional Genetics, Inc.

Phone: +1.240.631.6790

Email: info@functional-genetics.com

• September 29, 2009 -- VIROLOGY JOURNAL

http://www.f1000biology.com/article/id/1160576/evaluation

• June, 2009 -- Function-First Approaches to Improve Target Identification in Cancer

“The development of broad-spectrum antivirals is our core area of focus and we are proud to introduce our work.” said Michael Kinch, Ph.D., vice president, research and development. Functional Genetics research scheduled to be presented includes:

RECRUITMENT OF THE TSG101/ESCRT-I MACHINERY IN HOST CELLS BY INFLUENZA VIRUS: IMPLICATIONS FOR BROAD SPECTRUM THERAPY as a platform presentation on May 6.

IDENTIFICATION OF A SMALL-MOLECULE ANTIVIRAL WITH BROAD-SPECTRUM APPLICATION TO MULTIPLE, LETHAL VIRUS TYPES as a platform presentation on May 7.

About Functional Genetics, Inc.
Functional Genetics, Inc. (FGI) is a privately-held, development stage biotechnology company, headquartered in Gaithersburg, MD. We use innovative science to develop better medicines to treat or prevent infectious diseases and cancer. Our unique scientific approaches have allowed us to develop novel antiviral drugs that demonstrate beneficial activity against a broad-spectrum of different viruses, including HIV, RSV, Influenza, HBV, HCV and bio-threat pathogens, such as Ebola.
For more information, visit Functional Genetics’ website at www.functional-genetics.com.

The agreement establishes the framework for Functional Genetics and Elanco to develop and potentially commercialize products using Functional Genetics’ proprietary targets and technologies. Under the agreement, Functional Genetics may receive technology access fees, regulatory milestone payments and royalties from sales.

“We are very pleased to have reached this agreement with Elanco, a leading global animal health company,” said Michael Goldblatt, president and chief executive officer of Functional Genetics. “Functional Genetics and Elanco share the vision to leverage the emerging paradigm of host-oriented therapeutics for new drug development and to utilize our core RHGP technology for target identification in other therapeutic areas. We are excited to work very closely with the Elanco team to achieve these goals.”

About Functional Genetics, Inc. Functional Genetics, Inc. (www.functional-genetics.com) uses innovative science to develop new therapeutics for infectious disease and to improve the quality and efficiency of biologics. FGI applies strategies to medically-relevant and commercially-attractive opportunities. Its products also address widespread and intractable diseases that have persistently inflicted considerable suffering and death.

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.

For further information contact: Functional Genetics, Inc. Dr. Michael Kinch (240) 631-6799 mkinch@functional-genetics.com

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=18066034

Functional Genetics, Inc. announced today that it has received an
award from the National Institute of Allergy and Infectious Diseases,
part of the National Institutes of Health, to discover new
opportunities to treat HIV, the cause of AIDS.

"This new award allows Functional Genetics to apply its innovative new
approaches to help in the fight against HIV/AIDS," said Michael
Goldblatt, Chief Executive Officer. “Functional Genetics is dedicated
to discovering new drugs that protect and treat virus infections that
cause considerable death and disease. The Company has already applied
its approaches to develop broad-spectrum therapeutics designed to
prevent or treat diseases that impact both the civilian and military
communities.”

Functional Genetics will apply its proprietary Random Homozygous Gene
Perturbation (RHGP) technology to identify host targets for drugs that
can be safely delivered to prevent or treat HIV infection. “This new
opportunity complements Functional Genetics’ pioneering efforts to
develop broad-spectrum anti-infectives based on the concept of denying
microbes the opportunity to harm patients,” added Dr. Goldblatt. The
program is designed to overcome issues that have previously eluded
anti-infective therapies, including acquired drug resistance and the
narrow application of current antivirals.

About Functional Genetics, Inc.
Functional Genetics is a privately-held biopharmaceutical company
dedicated to advancing science to combat intractable human diseases.
The company's initial therapeutic products, through its innovative
focus of Host Oriented Therapeutics, address the unmet medical need
for effective therapies to combat a broad spectrum of infectious
diseases. These new drugs are designed to circumvent microbial
resistance, which often causes therapeutic failures. Functional
Genetics has identified and is establishing medical validity of
therapeutics that target host proteins required for the propagation
and pathogenicity of disease-causing viruses including HIV, Influenza,
RSV, and diseases of bioterrorism such as Ebola. The Company is
currently moving toward clinical testing of the first of its new
generation of broad spectrum anti-viral products. The Company's has
also developed technologies that dramatically increase the efficiency
of biomedicine production. Functional Genetics is headquartered in
Gaithersburg, Maryland. For more information, visit the company's
website at http://www.functional-genetics.com.

Source: Functional Genetics, Inc.
Contact: Media: Michael Kinch at 240-631-6799.

"Safe Harbor" Statement under the Private Securities Litigation Reform
Act of 1995: Statements in this press release regarding Functional
Genetics’ business which are not historical facts are "forward-looking
statements" that involve risks and uncertainties.

###

Functional Genetics, Inc. announced today that it has received two
different awards from the United States Defense Threat Reduction
Agency for the discovery and development of therapeutics for Ebola
virus and other viral pathogens.

"These awards from DTRA will greatly assist our mission of discovering
innovative means to combat infectious disease," said Michael
Goldblatt, Chief Executive Officer of Functional Genetics. "Functional
Genetics is committed to developing broad-spectrum, host-oriented
therapeutics for the treatment of infectious diseases that impact both
the civilian and military communities."

Under the agreement, Functional Genetics will direct the development
of two distinct approaches to target virally-infected cells.
Functional Genetics has been pioneering new opportunities to develop
anti-infective therapeutics using its novel Host-Oriented Therapeutics
(HOT) strategy. Funding from DTRA will sponsor the development of two
very different, yet broad-based, therapeutics for viral disease. Both
programs are specifically designed to overcome issues that have
previously eluded anti-infective therapies, including acquired drug
resistance and the relatively narrow spectrum of current therapies.
These programs will include the development of at least one antibody
product and one small molecule inhibitor of hemorrhagic fever viruses,
including Ebola. Functional Genetics will conduct this program in
collaboration with The US Army Medical Research Institute of
Infectious Diseases (USAMRIID). The small molecule program will
utilize novel technologies pioneered by an additional subcontractor,
Evolva SA (Allschwil, Switzerland). These programs are intended to
allow Functional Genetics to advance new therapeutic opportunities for
viral infection to clinical trials. The initiation of this
collaboration is another step in Functional Genetics’ ongoing
commitment to develop innovative broad-spectrum anti-infectives.

About Functional Genetics, Inc.

Functional Genetics is a privately-held biopharmaceutcal company
dedicated to advancing science to develop novel approaches that
address intractable human diseases and means of accelerating
therapeutic options. The Company was formed to leverage its
proprietary Random Homozygous Gene Perturbation (RHGP) technology in
the creation of new therapies and enhancement of industrial
bioprocessing. The company's initial therapeutic products, through its
enabling focus of Host Oriented Therapeutics, address the unmet
medical need of developing highly effective broad spectrum therapies
for infectious diseases. These broad spectrum products are designed to
circumvent microbial resistance mechanisms that often lead to
therapeutic failures. Functional Genetics has identified and is
establishing medical validity of treatments that target host cellular
proteins required for the propagation and pathogenicity of disease-
causing viruses including HIV, Influenza, RSV, and diseases of
bioterrorism such as Ebola. The Company is currently moving toward
clinical testing of the first of its new generation of broad spectrum
anti-viral products. The Company's first industrial product is an
enhanced cell line whose individual cell productivity is significantly
superior to those of existing cell lines. Functional Genetics is
headquartered in Gaithersburg, Maryland. For more information, visit
the company's website at http://www.functional-genetics.com.

About Evolva.

Evolva evolves small molecule drugs using massively combinatorial gene
libraries that drive chemistry rich pathways. Its Watchmaker®
technology platform replicates, on an industrial basis, the ability of
nature to evolve molecules with exquisite “design”, but with the
evolution directly aimed at making functional drugs – HIV blockers,
anti-obesity compounds etc. Watchmaker® can create, optimize and
manufacture molecules that are outside the scope of the traditional
synthetic approaches of the industry. For more information see www.evolva.com

About the Defense Threat Reduction Agency (DTRA)

The Defense Threat Reduction Agency (DTRA) safeguards America and its
allies from weapons of mass destruction by providing capabilities to
reduce, eliminate, and counter the threat, and mitigate its effects.
This Department of Defense agency is located at Fort Belvoir,
Virginia, and operates field offices worldwide. For further
information see www.dtra.mil

This announcement contains, in addition to historical information,
certain forward-looking statements that involve risks and
uncertainties, in particular, related to the research and development
of a potential treatment for viral diseases. Such statements reflect
management's current views and are based on certain assumptions.
Actual results could differ materially from those currently
anticipated. There can be no assurance that such development efforts
will succeed, that such products will receive required regulatory
clearance or that, even if such regulatory clearance is received, such
products will ultimately achieve commercial success.

SOURCE: Functional Genetics, Inc.

CONTACT: Media: Michael Kinch at +1-240-631-6799.

"Safe Harbor" Statement under the Private Securities Litigation Reform
Act of 1995: Statements in this press release regarding Functional
Genetics’ business which are not historical facts are "forward-looking
statements" that involve risks and uncertainties.