-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, NSdS//MfkkLt3hLsiW1frjfwe/5m1ay5XNc9zaSNbZDoLtEHuzJQ7gPWGvacaR6d AqLNAQ3kJtjdzOtvG7R53A== 0001299933-07-000939.txt : 20070215 0001299933-07-000939.hdr.sgml : 20070215 20070215172109 ACCESSION NUMBER: 0001299933-07-000939 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070209 ITEM INFORMATION: Unregistered Sales of Equity Securities ITEM INFORMATION: Other Events FILED AS OF DATE: 20070215 DATE AS OF CHANGE: 20070215 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMMUNE RESPONSE CORP CENTRAL INDEX KEY: 0000817785 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 330255679 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-18006 FILM NUMBER: 07628477 BUSINESS ADDRESS: STREET 1: 5931 DARWIN COURT CITY: CARLSBAD STATE: CA ZIP: 92008 BUSINESS PHONE: 7604317080 MAIL ADDRESS: STREET 1: 5931 DARWIN COURT CITY: CARLSBAD STATE: CA ZIP: 92008 8-K 1 htm_18235.htm LIVE FILING The Immune Response Corporation (Form: 8-K)  

 


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

     
Date of Report (Date of Earliest Event Reported):   February 9, 2007

The Immune Response Corporation
__________________________________________
(Exact name of registrant as specified in its charter)

     
Delaware 000-18006 33-0255679
_____________________
(State or other jurisdiction
_____________
(Commission
______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
5931 Darwin Court, Carlsbad, California   92008
_________________________________
(Address of principal executive offices)
  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   (760) 431-7080

Not Applicable
______________________________________________
Former name or former address, if changed since last report

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[  ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[  ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[  ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[  ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 3.02 Unregistered Sales of Equity Securities.

As previously reported, in March 2006 we closed a private placement of secured convertible notes and warrants to accredited investors. The notes had an aggregate original principal amount of $8,000,000. The conversion price of the notes is (giving effect to our December 2006 1-for-100 reverse stock split) $2.00 per share. The noteholders also received warrants entitling them to (giving effect to our December 2006 1-for-100 reverse stock split) purchase 12,000,000 shares of our common stock at $2.00 per share. The warrants are divided into two tranches, each consisting of warrants to (giving effect to our December 2006 1-for-100 reverse stock split) purchase 6,000,000 shares. The unexercised warrants from the first tranche expired on August 7, 2006.

On February 9, 2007 one noteholder converted $20,000 of outstanding principal balance plus accrued interest of $1,507 into 10,754 shares of common stock pursuant to the terms of the notes at $2.00 per share.

The 10,754 note conversion shares were issued to the accredited investor noteholder pursuant to the Securities Act Section 3(a)(9) registration exemption.

After the February 9, 2007 note conversion, the aggregate outstanding principal balance of the notes is $5,417,500.





Item 8.01 Other Events.

On February 15, 2007 we issued the attached press release announcing preliminary Phase II study results.






SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

         
    The Immune Response Corporation
          
February 15, 2007   By:   /s/ Michael K. Green
       
        Name: Michael K. Green
        Title: Chief Operating Officer and Chief Financial Officer


Exhibit Index


     
Exhibit No.   Description

 
99
  2-15-07 Press Release
EX-99 2 exhibit1.htm EX-99 EX-99

FOR IMMEDIATE RELEASE

THE IMMUNE RESPONSE CORPORATION’S INTERIM PHASE II DATA SUGGEST BOTH REMUNE AND IR103 STABILIZE
CD4+ CELL COUNTS
IN DRUG-NAïVE HIV PATIENTS

— Vaccines’ Ability to Strengthen Key Elements of the Immune System Holds Promise For New
Approach to HIV Treatment —

CARLSBAD, California, February 15, 2007 — The Immune Response Corporation (OTCBB: IMRP) today announced preliminary Phase II study results suggesting that both Remune® and IR103, its first and second generation HIV vaccine candidates, stabilize CD4+ T-cell counts compared with placebo in HIV patients who have not started antiretroviral (ARV) therapy. The 36-week data are from a year-long multi-center safety and immunogenicity study expected to conclude in 2008.

CD4+ T-cells, also known as helper T-cells, are key elements of the immune system and are specifically attacked and killed by the HIV virus. CD4+ count is a critical marker of HIV disease progression that is used in clinical decision-making. Unlike currently available drugs that attack the virus, Remune® and IR103 are designed to stimulate the body’s own immune system to better fight the virus by boosting T-cell activity.

“What is important and encouraging here is that the stabilization of CD4+ counts mirrors what we observed in an earlier 28-week study, presented last year at the Conference on Retroviruses and Opportunistic Infections, and suggests that this effect is reproducible and can be sustained for at least 36 weeks,” said Dr. Joseph O’Neill, President and CEO of The Immune Response Corporation. “IRC is committed to rigorous science and we look forward to the full 52-week trial results to help inform our future planning.”

The goal of The Immune Response Corporation’s research program is to deliver important clinical advances for patients suffering from devastating diseases. The Company’s investigational vaccines for HIV and multiple sclerosis are highly targeted, potentially less toxic medicines that seek to harness the body’s own defenses to control and prevent disease. This approach may prove valuable in the discovery of novel immune-based therapies for a host of autoimmune and infectious diseases.

The concept of an immune based treatment for HIV, pioneered by Remune®, has attracted the interest of researchers, physicians, and patients around the world. Immune Responses’ approach, which uses a whole-inactivated virus, may offer particular advantages in that it exposes the immune system to all of the core HIV proteins. “These data lend credence to the hypothesis that exposing HIV infected patients to an inactivated form of HIV, together with an appropriate adjuvant, could stimulate HIV specific immune responses and thereby prevent or retard further decline in immune function,” said Dr. Peter Salk, a member of the Company’s Scientific Advisory Board. “Should this approach to HIV treatment ultimately demonstrate clinical benefit it would be of great importance in the global fight against the HIV/AIDS pandemic”

About the Study
The trial (IR103-112) is a randomized, double-blind, multi-center safety study being conducted in Italy. The objective of the study is to examine the safety and the ability of Remune® and various doses of IR103 to generate HIV-specific immune responses in antiretroviral-naïve HIV infected subjects compared to placebo.

Patients in this interim analysis received either Remune® (n=10), IR103 0.1 mg (n=11), IR103 0.5 mg (n=11), IR1031.0 mg (n=11), or saline (n=12) every 12 weeks via intramuscular injection. CD4+ cell counts were measured at baseline and at weeks 4, 12, 24 and 36. While the data will not be statistically analyzed until completion of the trial, the data show a trend toward stabilization of CD4+ count in the immunized patients as compared to placebo at weeks 24 and 36.

No substantive difference in effect on CD4+ count was seen between Remune® and IR103 and no impact on viral load was detected at this point in the trial as compared to placebo.

Immunologic results from this initial cohort of 55 patients will be analyzed when they complete 52 weeks in the study. These data are expected to be submitted for presentation at a medical congress in mid 2007.

About The Immune Response Corporation
The Immune Response Corporation (OTCBB: IMRP, formerly 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™ for the treatment of multiple sclerosis (MS) and Remune® and IR103 for the treatment of HIV infection. These therapies are in Phase II clinical development and are designed to stimulate disease pathogen-specific immune responses aimed at slowing or halting the rate of disease progression.

NeuroVax™, 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™ 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.

Remune® and IR103 are 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 second-generation formulation that combines its whole-inactivated antigen with a synthetic Toll-like receptor (TLR-9) agonist designed to create enhanced HIV-specific immune responses. The Company is currently testing Remune® and 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.

NeuroVax™, Remune® 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 for additional information.

This news release contains forward-looking statements. Forward-looking statements are often signaled by forms of words such as should, could, will, might, plan, projection, forecast, expect, guidance, potential and developing. Actual results could vary materially from those expected due to a variety of risk factors, including whether the Company will continue as a going concern and successfully raise proceeds from financing activities sufficient to fund operations and additional clinical trials of NeuroVax™, Remune® or IR103, the uncertainty of successful completion of any such clinical trials, the fact that the Company has not succeeded in commercializing any drug, the risk that NeuroVax™, Remune® or IR103 might not prove to be effective as either a therapeutic or preventive vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of NeuroVax™, Remune® or IR103 in preclinical trials and/or earlier clinical trials. A more extensive set of risks is set forth in The Immune Response Corporation’s SEC filings including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2005, and its subsequent Quarterly Reports filed on Form 10-Q. The Company undertakes no obligation to update the results of these forward-looking statements to reflect events or circumstances after today or to reflect the occurrence of unanticipated events.

Remune® is a registered trademark of The Immune Response Corporation. NeuroVax™ is a trademark of The Immune Response Corporation.

         
MEDIA CONTACT:
  INVESTOR CONTACTS:   COMPANY CONTACT:
 
       
Rachel Kessler
Chamberlain
Communications Group Inc.
(212) 389-9155
  Robert Giordano
ROI Associates
(212) 495-0201
  Michael K. Green, COO
The Immune Response
Corporation
(760) 431-7080
 
       
rkessler@chamberlainpr.com
  rgiordano@roiny.com   info@imnr.com
 
       
 
       
 
  Gene Marbach
Makovsky & Company
(212) 508-9645
 


 
       
 
  gmarbach@makovsky.com  
 
     

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