Trades below comparables with drugs in Phase II Clinical Trial
IMNR – The Immune Response Corporation
StockGuru Profile IMNR
IMNR is a company engaged in two Phase II Clinical Trials. Consideration of the diseases that have the potential to be impacted by IMNR’s clinical trials indicate this company is trading significantly below its comparables. The Spelman Report has valued this stock significantly above where it is currently trading. The Spelman Research Report on The Immune Response Corporation is available at: http://www.roiny.com/clients-irc-research.php?f=IMNR-Spelman-Research-Report.pdf This report targets IMNR at $0.059 per share.
Let’s review the potential of IMNR:
Promising clinical trials. Phase I and II trials performed for both NeuroVax™ and IR103 have shown each drugs’ good safety profile and suggest their clinical efficiency. While further clinical research is required, this preliminary data suggests a relatively high probability of success.
Both drug candidates are in Phase II trials and the current and/or oncoming stages of trials are designed to be robust and provide clear answers about the effectiveness of the drugs. Phase II trials results should be available in early 2008, and if successful, should attract significant public and private partnerships for Phase III trials. Discussions about Phase III trials partnerships are already underway.
A Phase llb NeuroVax study is underway to establish a clinical benefit of NeuroVax to support a continuation to Phase lll trials. The 200+ patient, double blind placebo controlled study will be initiated at clinical sites in Eastern Europe. The primary endpoint is the cumulative number of lesions as detected by MRI scans. The secondary endpoint is relapse rates, neurological responses, safety, MS-specific immunology and other pertinent MRI data.
In October 2006, IMNR announced that it has entered into an agreement with Accelsiors CRO & Consultancy Services, a clinical research organization (CRO) with extensive experience in conducting multiple sclerosis (MS) trials, to oversee the 200-patient Phase II trial of NeuroVax(TM). The primary objective of the study is to compare the cumulative number of new gadolinium enhancing lesions, a key marker of MS disease activity, using MRI scans at 24, 32, 40, and 48 weeks. Secondary objectives include additional MRI measurements, analysis of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.
Possession of manufacturing facilities and “know how”. The company is planning to produce over one (1) million doses of IR103 per year, with a possibility to scale up this capacity to three (3) million doses, or even higher. Considering the dosage of 1/quarter, such capacity will be able to supply between 250,000 and 750,000 patients per year. IMNR also reports that it has the manufacturing expertise to produce NeuroVax internally when it makes business sense to do so. However, at the moment NeuroVax is manufactured by third parties. The company also affirmed that it currently does not have the capacity to produce IR103 in commercial quantities.
Potential for follow-up drugs based on the same technology. The research on NeuroVax has suggested that this approach may be used to treat other diseases. Thus, IMNR has open INDs for Psoriasis and Rheumatoid Arthritis. Moreover, because the technology is shared, it might be possible for the trials of the new drugs to take less time using some results from the previous research.
REMUNE(R) is a registered trademark of The Immune Response Corporation. NeuroVax(TM) is a trademark of The Immune Response Corporation.
For further information contact:
ROI Group Associates
39 Broadway; NY, NY 10006
212.495.0744
MDodge@roiny.com
Source:
IMNR — Immune Response Corp. (The)
5931 Darwin Court
Carlsbad, CA 92008
Website: http://www.imnr.com
Phone: 760-431-7080
Forward Looking Statement and Safe Harbor: Any information regarding The Immune Response Corporation (”IMNR”) in this communication is neither an offer nor solicitation to buy or sell any securities mentioned. While we believe all sources of information to be factual and reliable, in no way do we represent or guarantee the accuracy thereof, nor the statements made herein. THE READER SHOULD VERIFY ALL CLAIMS AND DO ITS OWN DUE DILIGENCE BEFORE INVESTING IN ANY SECURITIES MENTIONED. ROI Group Associates, Inc. (”ROI”) is the investor relations counsel for IMNR and accepts compensation from the IMNR for this effort, including a monthly cash retainer and restricted stock. Under the terms of its investor relations Service Agreement, ROI has agreed not to sell any of the IMNR restricted stock received as compensation under the Service Agreement during the entire term of its engagement as IMNR’s investor relations counsel pursuant to this Service Agreement. ROI shall be under no obligation to update readers about any restrictions on its trading activities regarding IMNR.
In addition to MS, IMNR has opened Investigational New Drug Applications (IND) with the U.S. Food and Drug Administration (FDA) for clinical evaluation of TCR peptide-based immune-based therapies for RA and psoriasis. IR103 is based on their patented whole-inactivated virus technology, co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE® , our 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. IMNR is currently testing IR103 in two Phase II clinical studies as a first-line treatment for drug-naïve HIV-infected individuals not yet eligible for antiretroviral therapy according to current medical guidelines. In early 2006 IMNR made a strategic decision to accelerate the development of IR103, rather than pursue a Phase III trial with REMUNE® . All of IMNR products are still in the development stage. IMNR has never had revenues from the sale of products. IMNR was founded in 1986.
Forward Looking Statement: This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. While these statements are meant to convey to the public the company’s progress, business opportunities and growth prospects, readers are cautioned that such forward-looking statements represent management’s opinion. While management believes such representation to be true and accurate based on the information available to the company, actual results may differ materially from those described. The company’s operations and business prospects are always subject to risks and uncertainties. Important facts that may cause actual results to differ are set forth in IMNR’s periodic filings with the U.S. Securities and Exchange Commission.
Disclosure: Pentony Enterprises LLC was compensated $50,000 from ROI Group Associates Inc. for profile coverage. Pentony Enterprises LLC is not a registered investment advisers or broker/dealers. Pentony Enterprises LLC makes no recommendation that the purchase of securities of companies profiled in this web site is suitable or advisable for any person or that an investment such securities will be profitable. In general, given the nature of the companies profiled and the lack of an active trading market for their securities, investing in such securities is highly speculative and carries a high degree of risk.
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