Expansion of Phase II/Immune Response Corp. (the Remune people)

[Jake72]

Apparently the folks behind Remune are developing with their second-generation (whatever happened to the first generation, huh?) therapeutic candidate.  It's going into an expansion of Phase II, but none of the trials are scheduled for the US.

The website is www.imnr.com

 June 19, 2006

The Immune Response Corporation Completes First Stage of Enrollment and Receives Approval for Expansion of Phase II Trial for Investigative HIV Immunotherapy IR103

Carlsbad, California – June 19, 2006 – The Immune Response Corporation (OTCBB: IMNR.OB) announced today the completion of the first stage of enrollment of drug-naïve HIV patients in a Phase II clinical study being conducted in Italy. The study, which has enrolled a total of 31 returning patients from a previous trial and 54 new patients, will examine IR103, a second generation immunotherapy, as a first-line treatment for drug-naïve HIV-infected individuals not yet recommended for antiretroviral therapy according to current medical guidelines. In addition, approval has been obtained for expansion of the study to include an additional 50 patients, and enrollment of the additional patients has begun. Ultimately over 200 drug-naïve patients will be enrolled in two parallel studies with sites in Italy, France, Canada and the UK.

The study, which includes a rollover patient population from a previous clinical study of the Company’s first generation immunotherapy, REMUNE®, is designed to assess the safety and ability of various doses of IR103 to induce HIV-specific immunity. The trial will also measure changes in CD4+ counts, a critical marker of HIV disease progression that is used, along with viral load, to determine when a patient should begin antiretroviral therapy. 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.

“We are very encouraged by the rapid recruitment of patients in Italy in the IR103 study,” said Georgia Theofan, Ph.D., Vice President of Clinical Development of The Immune Response Corporation. “We are looking forward to the expansion and enrollment of additional patients in Europe as we continue generating data on our second generation immune-based therapy for HIV in this important patient population.”

For more information about enrolling in this trial please contact The Immune Response Corporation at 760-431-7080 in the United States.

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.

[blondbeauty]

I thought remune was a complete failure.

[Jake72]

So did I, but apparently it and its successor are still being studied in trials, so much so that just last year the NIH selected Remune for a five-year clinical trial:

March 29, 2005

The Immune Response Corporation Announces That REMUNE®  Has Been Selected For A New HIV Clinical Trial Sponsored by The U.S. National Institutes of Health

Carlsbad, California – March 29, 2005 -- The Immune Response Corporation (Nasdaq: IMNR), a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis, announced today that the Company’s lead HIV product candidate, REMUNE® (gp120-depleted HIV-1 immunogen), will be included in a clinical trial funded by the U.S. National Institutes of Health (NIH). The NIH trial is designed to study antiretroviral therapy (ART) alone versus ART with a therapeutic HIV immunization, REMUNE®, in recently HIV-infected people. The study is expected to provide important information about the development of HIV disease and the protective role the immune system may play against HIV disease.

“We are excited that REMUNE® has been chosen for this important study which is designed to observe the effects of therapy in early stages of the disease. REMUNE® is the only immune-based therapy to be studied in this trial,” said John N. Bonfiglio, Ph.D., President and Chief Executive Officer of The Immune Response Corporation. “We are pleased that previous demonstrations of the ability of REMUNE® to induce strong new immune responses have led to its inclusion in this trial.”

The Immune Response Corporation’s REMUNE® is an immune-based therapy in development to treat individuals infected by the human immunodeficiency virus (HIV). REMUNE® is different from currently available antiretroviral drug therapies since it is designed to stimulate an HIV-infected individual’s immune system to attack HIV. The Company believes that results of previous clinical trials demonstrate that REMUNE® boosts HIV-specific immune responses and has the potential to slow the progression of HIV infection when used alone or in conjunction with antiretroviral therapy. Furthermore, the Company believes that REMUNE® stimulates the production of specific immune system modulators (cytokines and chemokines) that naturally protect components of the immune system from HIV infection.

“While we have previously studied REMUNE® in both ART-naïve HIV-infected patients and in HIV patients on ART, we believe REMUNE® may also be able to boost HIV-specific immune responses in patients with early stage HIV infection,” said Georgia Theofan, Ph.D., Vice President of Clinical Development at The Immune Response Corporation. “Our own clinical program is expanding to include additional studies in ART-naïve patients with both REMUNE® and IR103, our newest HIV product candidate.”

REMUNE® is in Phase II clinical trial development by The Immune Response Corporation and is not approved by any regulatory agencies in any country at this time.

About the NIH HIV Study

The U.S. National Institutes of Health (NIH) has funded a five-year randomized, controlled clinical trial investigating antiretroviral therapy (ART) alone versus ART with a therapeutic HIV immunization (REMUNE®), both including monitored treatment interruptions, in acute and recently HIV-infected subjects. The study will ultimately enroll 92 patients who will receive currently marketed ART drugs for the first 48 weeks of the study followed by administration of REMUNE® or placebo every 12 weeks for an additional 36 weeks. Patients will also undergo structured treatment interruptions following immunization, and will be followed for a minimum of three years. All patients will be followed with multiple immunologic tests in vitro. The trial will be conducted at NYU Medical Center and the University of Montreal/McGill University AIDS program.

http://www.imnr.com/news/2005/2005MAR29.htm

[ZCorker]

  I think one of us should contact them and find out if their latest vaccine is any different that the previous one that failed.  I do recall reading that in 2001, 3 women doctors at UCLA had taken the Remune Vaccine and modified it in such a way that they were able to protect the outer shell.  They had discovered this by reviewing more than ten years of vaccine trial records.

  What they found out was that by protecting the outer shell, the vaccine acted very differently in the body and caused the body to produce a very large amount of Gamma Interferon.  This is considered beneficial.  I haven't heard from them since and this might be a good time for one of us to contact them and report back on it.  If my memory is correct, one of the names of the doctors was Dr. Gervitz.  The article about the three women may have been written in POz.  I can't recall off the top of my head.  I would have to do some digging to see if I can find it.  I found the article in a tabloid at my doctors office while waiting for the doctor to come in.

   The question now is whether or not the latest Remune represents the new findings that were discovered by these 3 women UCLA researchers?

[Jake72]

And speaking of Remune, here's the latest press release, which deals with the manufacturing side of things (check out www.imnr.com):


 June 27, 2005

The Immune Response Corporation Announces Initial HIV-1 Viral Antigen Yields Improved at Least Two-Fold Through New Manufacturing Process
Medium Optimization Process Presented This Week at The Vaccine Technology Conference

Carlsbad, California – June 27, 2006 – The Immune Response Corporation (OTCBB: IMNR) announced today the development of a serum-free, chemically defined cell culture medium for the production of HIV-1 from HUT-78 cells, a human T-cell lymphoma cell line. A poster on the medium optimization process is being presented this week at the Vaccine Technology conference in Puerto Vallarta, Mexico. This conference is being held June 25th-30th, and is a biopharmaceutical development and manufacturing event with a special emphasis on HIV vaccine candidates and other global vaccines. The development of this medium is an important step in the development of a vaccine utilizing whole-inactivated HIV to stimulate the human immune system against the virus. The Immune Response Corporation is currently evaluating this approach for a therapeutic vaccine in clinical trials of its second-generation HIV immunotherapy IR103. This technology will also be utilized toward the development of a preventive vaccine candidate.

The purpose of a therapeutic vaccine for HIV is to bolster the immune system to more effectively mount a sustained attack against HIV-infected cells. This may be accomplished by allowing the body to create and maintain a memory of the core proteins making up the virus by exposing it to an inactivated form of HIV that could not infect or destroy the immune cells. In order to create this vaccine candidate, cells chronically infected with the virus require growth and expansion in large quantities. The resulting whole virus contained in the clarified production medium is then inactivated and further purified through a scientifically robust and strictly regulated process.

The Company has collaborated with Irvine Scientific, a leading medical device/biotechnology company located in Santa Ana, CA, to develop a chemically defined, serum-free cell culture medium for the production process that eliminates all animal-derived components, improves viral yield, and is designed to provide consistently high cell growth through to full-scale production, while maintaining the performance of the final vaccine product as an immunological stimulant against HIV.

“The progress reported at this conference represents a significant advance for the Company,” said Peter Lowry, Vice President of Manufacturing Operations at The Immune Response Corporation. “This new serum-free medium greatly enhances our ongoing efforts toward an efficient, economically viable, and reproducible manufacturing process that will allow us to produce safe and consistent whole-inactivated viral vaccines in large quantities.”

Through a process of screening and optimization, the Company demonstrated that the human T-cell lymphoma cell line HUT-78 (chronically infected with HIV-1) can be grown and reliably passaged in a chemically-defined cell culture medium, with cell densities exceeding two million cells/ml. In addition, initial HIV-1 viral antigen yields were improved at least two-fold over the serum supplemented medium originally used.

The Company believes that, in parallel with the continuation of the IR103 Phase II clinical program, this new medium represents a valuable step in the development of an economically sound and transferable manufacturing process for the vaccine in the future.

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 for the estimated 40 million adults and children living with HIV as of 2005.

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.

[J220]

Overall a step in a good direction. They'll get there someday.

[blondbeauty]

Someone, somewhere, somehow...

[dario]

good news ...