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Research in therapeutic vaccine for HIV

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The Immune Response Corporation Announces Initial HIV-1 Viral

Antigen Yields Improved at Least Two-Fold Through New Manufacturing

Process

The Immune ResponseCorporation (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

ResponseCorporation 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 Lowry, Vice President of

Manufacturing Operations at The Immune ResponseCorporation. " 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.

About The Immune Response Corporation

The Immune ResponseCorporation (OTCBB: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 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, 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 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 and IR103 are in clinical development by The Immune

ResponseCorporation and are not approved by any regulatory agencies

in any country at this time. Please visit The Immune

ResponseCorporation at www.imnr.com.

http://www.freshnews.com/news/biotech-biomedical/article_32745.html?

Immune Response

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