CARLSBAD, Calif., Nov. 14 /PRNewswire-FirstCall/ -- The Immune Response Corporation (BULLETIN BOARD: IMNR) announced today that the Company has reached an agreement with class counsel to settle the consolidated federal securities law class action litigation filed against the Company in 2001, as well as the related California state-court derivative lawsuit, without admitting to any wrongdoing, fault or liability. The settlements also include Company directors and officers who were named in the lawsuits.
The class action settlement, for approximately $9.6 million, will have no effect on the Company's operations, cash flow or financial position, as it is within insurance limits. The settlement is conditioned on notice to the class members and court approval. The preliminary settlement approval hearing is scheduled to occur on December 4, 2006.
The shareholder derivative complaint was filed on July 5, 2005 against certain of the Company's current and former officers and directors. The Company was also named as a nominal defendant in the complaint.
The $0.25 million settlement for the California state-court derivative lawsuit would also be funded entirely by the Company's insurers. As anticipated by an agreement in principle for the settlement, the Company will also agree to adopt certain corporate governance requirements. The definitive state-court settlement agreement is conditioned on court approval and must be filed with the court by November 20, 2006. The settlement hearing is scheduled to occur on November 27, 2006.
About The Immune Response Corporation
The Immune Response Corporation (BULLETIN BOARD: IMNR) is an immuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases. The Company's lead immune-based therapeutic product candidates are NeuroVax(TM) for the treatment of multiple sclerosis (MS) and IR103 for the treatment of HIV infection. Both of these therapies are in Phase II clinical development and are designed to stimulate pathogen-specific immune responses aimed at slowing or halting the rate of disease progression.
NeuroVax(TM), which is based on the Company's patented T-cell receptor (TCR) peptide vaccine technology, has shown potential clinical value in the treatment of relapsing forms of MS. NeuroVax(TM) has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all patients treated and appears to work by enhancing levels of FOXP3+ Treg cells that are able to down regulate the activity of pathogenic T-cells that cause MS. Increasing scientific findings have associated diminished levels of FOXP3+ Treg cell responses with the pathogenesis and progression of MS and other autoimmune diseases such as rheumatoid arthritis (RA), psoriasis and Crohn's disease. In addition to MS, the Company has open Investigational New Drug Applications (IND) with the FDA for clinical evaluation of TCR peptide-based immune-based therapies for RA and psoriasis.
IR103 is based on the Company's patented, whole-inactivated virus technology, co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of Remune(R), the Company's first generation HIV product candidate. The federal class action litigation was based on the Company's reporting of results from one of those clinical studies of Remune(R). IR103 is a more potent formulation that combines its whole-inactivated antigen with a synthetic Toll-like receptor (TLR-9) agonist to create enhanced HIV-specific immune responses. The Company is currently testing IR103 in two Phase II clinical studies as a first-line treatment for drug-naive HIV-infected individuals not yet eligible for antiretroviral therapy according to current medical guidelines.
NeuroVax(TM) and IR103 are in clinical development by The Immune Response Corporation and are not approved by any regulatory agencies in any country at this time.
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