Unique HIV Vaccine Elicits Strong Immune Responses

[datdude]

New Hope For HIV Vaccine: Unique HIV Vaccine Formula Elicits Strong Immune Responses
ScienceDaily (May 23, 2008) — Advanced BioScience Laboratories, Inc. (ABL) and the University of Massachusetts Medical School (UMMS) report that their unique HIV vaccine formulation was effective in eliciting strong and balanced immune responses in healthy human volunteers.  In light of these initial findings, additional assays on volunteers’ samples were done by researchers at the University of Alabama at Birmingham, independently confirming the presence of long lasting and high quality T cell responses against HIV antigens.



In this phase I clinical trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), volunteers first received three injections of a DNA vaccine which expresses protective antigens from the HIV virus, followed by two injections of a protein vaccine whose components matched those included in the DNA vaccine.  The report in Vaccine is the first scientific article in which a “DNA prime-protein boost” combination vaccination method is tested in humans for HIV vaccine development.  Scientists at ABL and UMMS and their collaborators discovered that this combination approach is highly effective in inducing strong antibody and cell-mediated immune responses in human volunteers.

“Given the challenges of developing a vaccine against HIV, scientists have long believed that a final, effective HIV vaccine will require the induction of balanced responses from both arms of human immune system.  Our results demonstrate that it is feasible to use this combination approach to achieve this objective,” said Phillip Markham, PhD, of ABL, the Principal Investigator (PI) on this vaccine development effort, performed under contract to the NIAID.

One unique design underlying this combination HIV vaccine formulation is the use of a “cocktail” of five different envelope (Env) proteins collected from HIV viruses circulating in different parts of the world. Env is a key protective antigen and the goal was to elicit broad antibody responses against a wide range of HIV viruses in order to counter the issue of frequent HIV mutations.  Indeed, the high titer antibodies found in volunteers’ sera were able to recognize each of a very diverse group of Env antigens that were included in this study.  More significantly, the majority of volunteers developed positive neutralizing antibodies against a good portion of the five HIV subtypes included in the assay.

Shan Lu, MD, PhD, professor of medicine and biochemistry & molecular pharmacology at the University of Massachusetts Medical School and the co- Principal Investigator (co-PI) of the vaccine development program, describes the finding of neutralizing antibodies in this study as “a major step forward.”

“Previously, we didn’t know where to start.  The neutralizing antibody titers in our study are still relatively low, but, these results are promising and open the door for future efforts to optimize HIV vaccine formulations in order to achieve a protective HIV vaccine,” said Dr. Lu.

The dominant approaches in the current HIV vaccine field rely on viral vector-based delivery systems, an approach that produced disappointing results in a recent efficacy trial.  Drs. Markham and Lu believe their HIV vaccine strategy will offer an alternative approach to focus on the induction of protective antibodies for HIV vaccine development, while maintaining strong cell-mediated immune responses.

 In addition to NIH, the International AIDS Vaccine Initiative (IAVI) also provided funding support to part of the study.

Researchers from Duke University Medical School also participated, as did Dr. Paul Goepfert at the University of Alabama-Birmingham.

http://www.sciencedaily.com/releases/2008/05/080522104439.htm

[J220]

I read this too in Science Daily and came over here to share it...great news!!! Best of all this is already in phase 1 trial. Even though they make the comment that these results open the door to "a protective HIV vaccine,” if it works as a preventive vaccine by creating positive neutralizing antibodies then I would speculate that at very least it can do the trick of working as a therapeutic agent to replace meds, and at best an outright cure.

[datdude]

Study confirms efficacy of unique HIV formula

Washington, May 23 : Researchers at the University of Alabama at Birmingham (UAB) have confirmed initial findings that a unique HIV vaccine formula is effective in eliciting strong and balanced immune responses.


Their study built on a previous study wherein experts at Advanced BioScience Laboratories and University of Massachusetts Medical School tested the vaccine formula on healthy human volunteers.

In the current study, published in the Journal of Virology, the UAB researchers carried out further assays on samples taken from the same volunteers who participated in the previous study.

The team says that their study confirms the presence of long lasting and high quality T cell responses against HIV antigens.

The phase I clinical trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), saw volunteers receive there injections of a DNA vaccine which expresses protective antigens from the HIV virus, followed by two injections of a protein vaccine whose components matched those included in the DNA vaccine.

A research article on the trial conducted by scientists at ABL and UMMS appeared in the journal Virology, saying that a "DNA prime-protein boost" combination vaccination method seemed to be highly effective in inducing strong antibody and cell-mediated immune responses in human volunteers.

"Given the challenges of developing a vaccine against HIV, scientists have long believed that a final, effective HIV vaccine will require the induction of balanced responses from both arms of human immune system. Our results demonstrate that it is feasible to use this combination approach to achieve this objective," said Dr. Phillip Markham of ABL, the Principal Investigator (PI) on this vaccine development effort.

One unique design underlying this combination HIV vaccine formulation is the use of a "cocktail" of five different envelope (Env) proteins, key protective antigens, collected from HIV viruses circulating in different parts of the world.

The objective behind the study was to elicit broad antibody responses against a wide range of HIV viruses in order to counter the issue of frequent HIV mutations.

Indeed, the high titer antibodies found in volunteers' sera were able to recognize each of a very diverse group of Env antigens that were included in the study.

The majority of participants developed positive neutralizing antibodies against a good portion of the five HIV subtypes included in the assay.

Dr. Shan Lu, professor of medicine and biochemistry & molecular pharmacology at the University of Massachusetts Medical School and the co- Principal Investigator (co-PI) of the vaccine development program, said that the finding of neutralizing antibodies in the study was "a major step forward."

"Previously, we didn't know where to start. The neutralizing antibody titers in our study are still relatively low, but, these results are promising and open the door for future efforts to optimize HIV vaccine formulations in order to achieve a protective HIV vaccine," said Dr. Lu.

The dominant approaches in the current HIV vaccine field rely on viral vector-based delivery systems, an approach that produced disappointing results in a recent efficacy trial.

Drs. Markham and Dr. Lu said that their HIV vaccine strategy might offer an alternative approach to focus on the induction of protective antibodies for HIV vaccine development, while maintaining strong cell-mediated immune responses.                                                                 http://www.newkerala.com/one.php?action=fullnews&id=64055

[bimazek]

good news
and somewhat similar to the opal mega vaccine

the vaccine used here was
the use of a “cocktail” of five different envelope (Env) proteins

'OPAL Therapy' was
823 peptides spanning all SIVmac proteins (Gag, Pol, Env, Nef, Vif, Tat, Rev, Vpr, Vpx) [peptides are parts of proteins]

both have Env envelope (Env) proteins

[bimazek]

What is strange to me is why have they not been trying different mixes of cocktails of hiv proteins and peptides for last 25 years, seems like first thing to do, anyone know the answer to why hiv proteins and peptides or groups of them have not been tried since the very beginning? 

[bimazek]

yet another great new therapudic vaccine testing  http://www.abnnewswire.net/press/en/52491/Bavarian.html
 important implications in a prophylactic and therapeutic vaccine for HIV.

Bavarian Nordic Enters Clinical Trials With HIV Multiantigen Vaccine

Bavarian Nordic A/S Bavarian Nordic has initiated Phase I/II clinical study with its HIV vaccine candidate: MVA-BN® HIV multiantigen.

A Phase I/II safety and immunogenicity study in 15 HIV-infected patients (CD4 counts > 350 ul/ml) has begun enrolment in the United States. The first safety data are expected by the end of 2008, while the immunogenicity data will be available during first half of 2009.

The MVA-BN® HIV multiantigen vaccine encodes eight genes from HIV, including Nef and thus represents a more advanced vaccine candidate compared to Bavarian Nordic's previous MVA-based HIV vaccine candidates, MVA HIV nef and MVA-BN® HIV polytope.  HIV multiantigen builds on these positive results and thus represents an excellent opportunity to stimulate a broad immune response to the majority of the HIV proteins that will likely have important implications in a prophylactic and therapeutic setting for HIV.

[Cosmicdancer]

Here's an article about another therapeutic vaccine that shows promise in an animal study...

http://phx.corporate-ir.net/phoenix.zhtml?c=63617&p=irol-newsArticle&ID=1163641&highlight=

Lipid Sciences' Autologous Therapeutic HIV Vaccine Study Published in""Experimental Biology and Medicine""
 
SIV-Infected Non-Human Primates Respond Well to Novel Therapeutic Treatment

Jun 9, 2008 08:31:12 (ET)

PLEASANTON, CA, Jun 09, 2008 (MARKET WIRE via COMTEX) -- Lipid Sciences, Inc. (LIPD, Trade ) announced that the results of a proof-of-concept study that demonstrated a positive therapeutic effect with the Company's proprietary autologous virus vaccine in SIV-infected non-human primates was published in an original research article entitled, "Delipidated Retroviruses as Potential Autologous Therapeutic Vaccines -- A Pilot Experiment." The article appeared in Experimental Biology and Medicine (233:732-740,2008). The abstract and article are available on the Company's website: www.lipidsciences.com under the heading Scientific Abstracts and Publications.
This pilot experiment consisted of four animals that were long-term ( > 1 year) chronically infected with Simian Immunodeficiency Virus (SIV) -- a widely-accepted model for HIV. At the initiation of the study, the animals were severely immune-compromised and experiencing typical symptoms of AIDS. Vaccination with autologous SIV, delipidated by Lipid Sciences' proprietary process, led to an average 8.6 times viral load reduction in the treated animals. The viral load change, pre- versus post-vaccination, was statistically significant (p < 0.001), indicating the strong benefit of autologous delipidated viral vaccination in lowering viral loads in chronically-infected animals. Furthermore, the vaccinated animals had a significant (p < 0.006) enhancement of survival when compared to a set of historical control animals. The animals also exhibited fewer symptoms of AIDS post-vaccination. These findings reaffirm the benefit of therapeutic vaccination, even in animals which are long-term chronically infected and severely immune-compromised. These findings have implication for the use of therapeutic vaccines in patients who are long-term chronically infected with HIV.

S. Lewis Meyer, Ph.D., President and Chief Executive Officer of Lipid Sciences, commented, "It is important to note that in a follow-up placebo-controlled study with early chronically-infected animals, the Company has further demonstrated a significant viral load reduction, pre- versus post-vaccination, in treated animals (p=0.03). These results, especially when viewed in the context of the recent, highly publicized failure of a large-scale HIV vaccine trial, clearly point the way to a new and novel avenue of HIV vaccine development. We are pursuing grant funding from a variety of governmental and private sources to move our HIV vaccine development program forward.

This pre-clinical study was conducted at the Yerkes National Primate Research Center at Emory University in Atlanta, under the direction of investigators including Dr. Aftab A. Ansari, Professor, Department of Pathology, Emory University School of Medicine; Dr. James E.K. Hildreth, Director, Center for AIDS Health Disparities Research, Meharry Medical College; and Dr. Francois Villinger, Professor, Department of Pathology, Emory University School of Medicine. Dr. Moiz Kitabwalla, Senior Manager of Viral Programs for Lipid Sciences acted as a co-investigator and as the coordinator for this study. Dr. Kitabwalla is the principal author of this article.

Lipid Sciences' Viral Immunotherapy is a broadly applicable platform technology that focuses on the removal of the lipid coatings from lipid-enveloped viruses utilizing the Company's proprietary delipidation technologies. In addition to HIV, conditions that could potentially be affected by these technologies include SARS and influenza. Lipid Sciences believes its Viral Immunotherapy platform also has applicability to a wide range of viruses impacting animal health -- a diverse market with diseases affecting both food and companion animals. In late 2006 Lipid Sciences entered into a collaborative research and license agreement with Elanco Animal Health, a division of Eli Lilly and Company, to address these animal health markets.

About Experimental Biology and Medicine (EBM): Experimental Biology and Medicine is a journal dedicated to the publication of multidisciplinary and interdisciplinary research in the biomedical sciences. Articles in EBM represent cutting edge research at the overlapping junctions of the biological, physical and engineering sciences that impact upon the health and welfare of the world's population.

Lipid Sciences, Inc. is a development-stage biotechnology company engaged in the research and development of products and processes intended to treat major medical indications, in which lipids, or fat components, play a key role. The Company's HDL Therapy platform (HDL Mimetic Peptides and HDL Selective Delipidation) aims to develop treatments to reverse atherosclerosis, a systemic disease caused by the build-up of cholesterol-filled plaques in the vascular system and, most critically, in the coronary arteries. Regression of such plaques may have a major impact on reducing the risk of acute coronary events. The Company's Viral Immunotherapy platform focuses on the removal of the lipid coatings from lipid-enveloped viruses and other lipid-containing infectious agents by applying Lipid Sciences' proprietary delipidation technologies. The Company believes that removing the virus' protective lipid coating enhances the processing and presentation of viral proteins to stimulate the body's immune system to effectively fight the disease. Conditions that could potentially be impacted by these technologies include HIV, SARS, and influenza. In addition, Lipid Sciences believes that this Viral Immunotherapy platform also has applicability to a wide range of viruses impacting animal health -- a diverse market with diseases affecting both food and companion animals.

Forward-Looking Statements: This release contains forward-looking statements concerning plans, objectives, goals, strategies, study results, anticipations, expectations, future events or performance as well as all other statements that are not statements of historical fact. The forward-looking statements contained in this release reflect our current beliefs and expectations on the date of this release. Actual results, performance or outcomes may differ materially from what is expressed in the forward-looking statements. Readers should refer to the documents filed by us with the SEC, specifically the most recent reports on Form 10-K and Form 10-Q which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements. In addition to those risk factors, other factors that could cause actual results to differ materially include the following: our inability to obtain adequate funds; our technologies not proving to be safe or effective; our inability to obtain regulatory approval of our technologies, which are only in the clinical development stage; delay or failure to complete clinical studies; our dependence on our license agreement with Aruba International B.V.; our reliance on collaborations with strategic partners and consultants; our reliance on key suppliers to provide the material necessary to conduct successful pre-clinical and clinical studies; competition in our industry, including the development of new products by others that may provide alternative or better therapies; failure to secure and enforce our intellectual property rights; risks associated with use of biological and hazardous materials; acceptance of our potential products by healthcare providers and patients; and our dependence on key personnel.

This release should be read in conjunction with the consolidated financial statements and notes thereto included in our most recent reports on Form 10-K and Form 10-Q. Copies are available through the SEC's Electronic Data Gathering Analysis and Retrieval system (EDGAR) at www.sec.gov . Lipid Sciences assumes no obligation to update the forward-looking statements included in this document.

Press releases for Lipid Sciences, Inc. are available on our website: www.lipidsciences.com . To receive the Company's press releases via email, please contact: info@lipidsciences.com.


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