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The Immune Response Corporation Announces That Phase II Preliminary Data Indicate Investigative HIV Immunotherapy IR103 Enhances Immune Responses in Antiretroviral Naive HIV-Infected Patients Monday June 26, 9:00 am ET Phase II Study Presented This Week at European HIV/AIDS Meeting in France
TOULON, France--(BUSINESS WIRE)--June 26, 2006--The Immune Response Corporation (OTCBB:IMNR - News) announced today that preliminary Phase II study results of its second-generation HIV immunotherapy, IR103, demonstrated a positive safety profile and enhanced immunomodulatory effects over REMUNE®, the Company's first-generation immunotherapy. IR103 is a co-formulation of REMUNE® and a novel synthetic Toll-like receptor (TLR-9) agonist adjuvant, Amplivax(TM). The results were presented at the International Symposium on HIV & Emerging Infectious Diseases (ISHEID) in Toulon, France. ADVERTISEMENT
IR103 differs from currently available antiretroviral drug therapies in that it is an immune-based therapy designed to replenish and enhance key immune cells that have been destroyed by the virus, thus allowing stimulation of an HIV-infected individual's immune system to fight the virus. According to the most recent guidelines for the use of antiretroviral agents (ARV's) in HIV-1 infected adults and adolescents issued by the U.S. Department of Health and Human Services (DHHS - May 2006), initiation of ARV's is not recommended for asymptomatic patients with CD4+ T-cell count greater than 350 cells/mm3 (CD4+ count serves as a critical marker of HIV disease progression that is used, along with viral load, to determine immunocompetence in patients with HIV infection). In these patients, there is little evidence of the benefit in initiating ARV therapy due in part to toxicity risks and adherence challenges.
"The early results for IR103 in this clinical study are encouraging," said lead investigator, Andrea Gori, MD, of the Department of Internal Medicine and Surgery at San Paolo Hospital, University of Milan. "We can now proceed to further investigate the potential advance that IR103 may provide through its unique ability to actively stimulate an HIV patient's immune system to fight the virus."
Many studies indicate that CD8 T-cells are a critical component of the immune response which can control HIV. HIV-1 infected patients typically show a defect in T-cell maturation, leading to decreased levels of the 'effector memory' cells. It has been shown that people with HIV-specific CD8 T-cells that mature fully into 'effector memory' T-cells are able to control viral load after stopping ARV treatment. This study, examining 31 ARV-naive patients returning from a previous trial of REMUNE® (randomized to receive either REMUNE® or IR103 every 12 weeks for a total of 5 injections), demonstrates a shift towards the more mature T-cell subtypes, thus increasing numbers of the 'effector memory' cells that have been described as capable of destroying HIV. Preliminary 4 and 12 week data suggest that these changes may occur more rapidly and at greater magnitude in patients receiving IR103 compared to REMUNE®. No safety issues were identified in any subjects through 12 weeks of evaluation.
The Company continues evaluating the clinical potential of IR103 to enhance immune response in patients. Another track of this Phase II study of IR103 completed the first stage of patient enrollment earlier this month and is designed to assess the safety and ability of various doses of IR103 to induce HIV-specific immunity, and also to measure changes in CD4 counts. The Company believes an immune-based therapy that stabilizes CD4 counts could be used to delay initiation of antiretroviral therapy and serve as an important advance in the treatment of HIV.
About IR103
More than 25 million people have died since human immunodeficiency virus (HIV) was first recognized in 1981 (source: UNAIDS, December 2005), and the new infection rate continues to grow at an alarming rate. Despite medical advances, the worldwide pandemic continues to claim more than 3.1 million lives each year (source: UNAIDS, December 2005). Additional safe and effective treatments are desperately needed.
IR103 is a second-generation HIV immunotherapy based on the Company's patented, whole-inactivated virus technology, which was co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE®, the Company's first generation HIV product candidate. Preclinical research and recent clinical data show that 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. This product differs from currently available antiretroviral drug therapies since it is designed to stimulate an HIV-infected individual's immune system to fight the virus.
About The Immune Response Corporation
The Immune Response Corporation (OTCBB:IMNR - News) 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 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 technology, has shown potential clinical value in the treatment of relapsing forms of multiple sclerosis (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®, the Company's first generation HIV product candidate. 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. Please visit The Immune Response Corporation at www.imnr.com.
Amplivax(TM) was developed by Idera Pharmaceuticals and has been licensed to The Immune Response Corporation.
Posts: 261 | From: NJ | Registered: May 2005
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Shares Outstanding: 254.11M Float: 141.28M Average Volume (3 month)3: 5,182,220 Average Volume (10 day)3: 32,736,900
% Held by Insiders4: 42.30% % Held by Institutions4: 4.70%
Formed a Harami today I am loving this stock for the long haul and I think that you will make great $$$ over the short term as well
Posts: 1104 | Registered: Dec 2005
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I'm not saying that it can't go down anymore but IMO is is forming a W and that is a plus. With the harami today we need tomorrow to confirm the reversal. I am in with 30k shares as of today so obviously I like the possibility of this taking off soon. This stock is on the blue light special I just don't know how long the special will last.
Posts: 1104 | Registered: Dec 2005
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my concern are the hiv drugs,, seems to be alot of delys and setbacks with all there products in the pipeline,,,,,?
Posts: 261 | From: NJ | Registered: May 2005
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Of course there could be delays but financing behind the company is getting better.
Carlsbad, CA -- May 9, 2006 -- The Immune Response Corporation (OTCBB:IMNR.OB) announced that it has issued notice to terminate its Standby Equity Distribution Agreement (SEDA), equity line of credit arrangement, with Cornell Capital Partners, LP.
“The termination of the SEDA is an important milestone in our long-term financing strategy,” said Michael Green, Chief Operating and Chief Financial Officer of The Immune Response Corporation. “The private placement financing campaign we completed this spring will fund a significant portion of our operations for the next two years. Many of the investors in our private placement have invested in the Company before, and have reaffirmed their belief in our research and long-term prospects by participating in this latest round. Their support allows us to focus on rigorous clinical testing of our most promising immune-based therapies for MS and HIV, which are both in Phase II trials supervised by distinguished scientific and clinical experts. Results from earlier trials have been very encouraging and give us cause to be excited about future possibilities for the Company.”
Posts: 1104 | Registered: Dec 2005
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On the 20th of june Kevin Reilly and Alan S Rosenthal purchased 1,875,000 shares each at a price of .02. On the 15th of june David P Hochman purchased 500,000 share at a price of .02
All are directors of the company
Do you think they know there stock is undervalued?
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The Immune Response Corporation's Manufacturing Facility, located in King of Prussia, Pennsylvania, is a 50,000 square GMP facility that conforms with the FDA's requirements for Good Manufacturing Practices (GMP) and is equipped for all aspects of the production of REMUNE®.
The facility contains two Bio-Safety Level 3 (BSL-3) manufacturing suites that are required for the production of viral agents such as the Human Immunodeficiency Virus (HIV). One of these suites contains all of the equipment and support systems required for the large-scale cell culture production of HIV, including multiple 250 liter fermenters. The second suite contains the equipment and systems required for the inactivation and purification of the HIV immunogen. The facility also contains a fully equipped Class 100 Formulation and Filling suite for the preparation of final dosage forms. Temperature-controlled warehousing for storage of production materials and final product, Quality Control testing laboratories, and a Process Development lab are also contained within the facility. A fully validated Water-For-Injection system, clean-air systems and all the associated utilities and support systems required for pharmaceutical production are part of this facility.
The facility has been in operation since 1995, supporting several large clinical trials. In 1999, a major construction project was initiated, which will result in an increased capacity for commercial-scale production of REMUNE®. It is projected that approximately one million doses per year can be manufactured.
Posts: 261 | From: NJ | Registered: May 2005
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The Immune Response Corporation (OTCBB: IMNR) announced Tuesday that equity research firm, IncreMental Advantage, had initiated coverage on the company with an Accumulate rating and a price target of 9 cents per share.
Posts: 404 | From: Germany | Registered: Jan 2006
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IncreMental Advantage Initiates Coverage of The Immune Response Corporation with Price Target of $0.09 Per Share, Accumulate Rating Monday July 24, 9:25 am ET
CARLSBAD, Calif.--(BUSINESS WIRE)--July 24, 2006--The Immune Response Corporation (OTCBB: IMNR - News) announced today that IncreMental Advantage, an equity research firm, has initiated coverage on the Company with an Accumulate rating, and a price target of $0.09 per share. The Immune Response Corporation's product pipeline has two clinical stage therapeutics in Phase II development, NeuroVax(TM) for multiple sclerosis (MS), and IR103 for HIV/AIDS. The report was issued by IncreMental's highly experienced biotechnology analyst, Robert LeBoyer, who has more than 14 years of Wall Street experience. ADVERTISEMENT
IncreMental Advantage noted in the report that, "The current market capitalization is only $13.1 million. It is unusual to find such a company with two novel products in Phase II clinical trials."
"We believe the Company's clinical programs and valuation justify a market capitalization of $200 million to $225 million. If we divide market valuation by the total number of shares outstanding at this time (current), the valuation is $0.31 to $0.38 per share. Dividing market capitalization by fully diluted shares outstanding gives a valuation of $0.08 to $0.09 per share ... When the current stock price is compared with the potential from the company's products, its equity seems almost like a non-expiring option on the trials. We believe these factors make IMNR an undervalued stock," concluded LeBoyer in his report.
For additional information, please email ROI Group Associates at imnr*roiny.com or call Mike Dodge at 212-495-0744.
IncreMental Advantage is an equity research and think tank that publishes research on companies and breaking developments on issues ranging from advertising to water utilities. IncreMental's research is highly regarded among institutional and individual investors from all over the world. Their research and events are dedicated to helping senior executives and institutional investors achieve IncreMental Advantages in their fields of expertise.
Posts: 404 | From: Germany | Registered: Jan 2006
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