iTherX Pharmaceuticals to Initiate Proof of Concept Clinical Study for First-in-Class Treatment for Hepatitis C
-- ITX5061 Inhibits Ability of Virus to Enter Liver Cells --
San Diego – February 3, 2009

iTherX Pharmaceuticals Inc, a privately held biopharmaceutical company developing novel antiviral products, today announced that it will initiate a Phase 2a clinical study of ITX5061, a potential therapy targeted at inhibiting the entry of the Hepatitis C virus (HCV) into liver cells. The placebo-controlled, randomized trial is a parallel-group dose-response study of the ability of ITX5061 to reduce viral load in treatment-naive and previously treated patients with HCV infection, when ITX5061 is administered as a single agent.

"ITX5061 is an inhibitor of the entry of HCV into liver cells with a potency in the picomolar range, and is equally potent against both genotype 1 and genotype 2 viruses," said Jeffrey McKelvy, Chief Executive Officer of iTherX. "This molecule has exhibited a good safety profile in preclinical studies and in previous clinical studies involving over 250 subjects. Our Phase 2a study represents a first-in-class clinical efficacy study for a small molecule HCV entry inhibitor. We look forward to carrying out further clinical studies to demonstrate the value of ITX5061 in the treatment of this serious illness, which is poorly treated with current therapy."

"Viral entry inhibitors represent a novel and interesting new class of antiviral agents," said John McHutchison, MD, Professor of Medicine at Duke University and Chairman of iTherX Scientific and Clinical Advisory Board. "Such agents could potentially be combined with current standard of care and emerging therapies for the treatment of HCV, since viral entry is involved in both the initiation and maintenance of infection. Moreover, studying combinations of antiviral agents that work through multiple mechanisms of action can be scientifically important, as it enables us to understand the potential clinical applications from both an efficacy and safety point of view. Such combination studies are especially interesting if the compound has a novel mechanism and is highly potent, as ITX5061 is."

The Phase 2a study will enroll approximately 40 patients at three centers in Europe. Primary endpoints for the study will be efficacy as measured by reduction in viral load. Safety and pharmacokinetics will also be assessed.

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iTherX Pharmaceuticals Inc, a privately held biopharmaceutical company, today announced that it has appointed a Scientific and Clinical Advisory Board to assist the company in the development of its novel therapeutic agents for Hepatitis C. iTherX is pioneering the introduction of a novel class of antivirals called entry inhibitors. These agents prevent the first step in virus infection: fusion with and entry into the liver cell. The company has identified unique molecular targets for Hepatitis C, and is developing two distinct series of therapeutics: HepaBloc™, which targets host cell proteins involved in infection, and FusiBloc™, which targets the viral envelope. In addition, iTherX scientists have identified a novel host cell receptor required for virus entry and will begin drug development against this target.

“Members of the newly formed Advisory Board include: John McHutchison, MD (Chair) Professor of Medicine, Division of Gastroenterology and Associate Director, Duke Clinical Research Institute, Duke University; Charles Rice, PhD, Professor of Virology, Rockefeller University and Director, Center for the Study of Hepatitis C; Robert Schooley, MD, Professor and Head, Division of Infectious Diseases, UCSD School of Medicine; and, Alan Perelson,PhD, Senior Fellow, Los Alamos National Laboratory.

“"We are pleased to welcome this distinguished group to help guide us in our development of this new class of drugs to combat hepatitis C, which is the major cause of chronic liver disease, liver failure and primary liver cancer," said Jeffrey McKelvy, Chairman and CEO of iTherX. Added McKelvy: "With this Advisory Board and our own scientific leadership by Dr. Flossie Wong-Staal, Chief Scientific officer of iTherX, and an internationally recognized virologist and a pioneer in the HIV field, iTherX is uniquely positioned to be a leader in the development of antiviral therapies."

iTherX Pharmaceuticals Inc. (San Diego, CA) is a private, pharmaceutical company focused on the discovery, development and commercialization of innovative products for the oncology and antiviral marketplaces. Additional information on the Company can be found at www.itherx.com

Immusol Changes Name to iTherX, Names Jeffrey F. McKelvy President and Chief Executive Officer
San Diego – December 11, 2007

Immusol Inc, a privately held biopharmaceutical company, today announced that it has changed its name to iTherX and has appointed Jeffrey F. McKelvy as President, Chief Executive Officer and Director.
“Immusol has evolved from its initial focus on discovery research to become an integrated biopharmaceutical company. To accompany this transformation, we are bringing on board an experienced pharmaceutical executive to lead the company. Our name change also reflects our mission to bring innovative therapeutic products to the marketplace”, said Tsvi Goldenberg, founding CEO of Immusol, who will remain as Chairman. McKelvy joins from Avera Pharmaceuticals, a privately held specialty pharmaceutical company, where he had been founding CEO, and then President and Chief Technical Officer. He brings to iTherX a 20 year career of senior executive experience in both start up and global pharmaceutical companies. Previous assignments included Vice President and San Diego Site Head, Merck Research Laboratories; Executive Vice President, Chief Scientific Officer and Director, SIBIA, a publically held biopharmaceutical company; Senior Vice President, CNS Strategic Business Unit, Ciba Geigy; founding CEO Trophix Pharmaceuticals, a privately held biopharmaceutical company and Venture Head, Abbott Laboratories. In the course of these assignments, McKelvy led the registration of several marketed products, including Gabitril®, Serlect® and Tegretol Oros®.

“iTherX has an exceptionally strong scientific foundation for product development due to the leadership of Flossie Wong-Staal, a world class scientist who co-founded Immusol. Jeff McKelvy brings an outstanding record of achievement in the pharmaceutical industry, and his strong background in drug development will enable the Company to move its assets rapidly to the achievement of significant milestones”, said Frank Litvack, co-founder and Director of Immusol, and now a Director of iTherX. Dr. Wong-Staal remains as Executive Vice President, Director and Chief Scientific Officer for iTherX. Added Dr. Jeffrey McKelvy, “The Company’s pipeline is now focused on two major programs, oncology and virology, with the potential to deliver first in class agents for the treatment of solid tumors and hepatitis C respectively. Moreover, the Company has the capability to move these compounds to the Proof of Concept stage in clinical studies, and to create significant value in doing so”.

iTherX Pharmaceuticals Inc. (San Diego, CA) is a private, pharmaceutical company focused on the discovery, development and commercialization of innovative products for the oncology and antiviral marketplaces. Additional information on the Company can be found at www.itherx.com