Die Wunderwaffe bei Erkrankungen des 21. Jahrhunderts
Bahnbrechende Produkte revolutionieren die Behandlung von Multipler Sklerose und HIV!
Noch vor einem Jahrhundert hatte der visionäre Bakteriologe Paul Ehrlich die These, dass das körpereigene Immunsystem sich teilweise selber bekämpft. Einen anderen Begriff den Ehrlich schuf, war der der Autoimmunität, der für die körpereigene Abwehr gegen Krankheiten steht. Doch die Gemeinschaft der damaligen konnte dieser widersprüchlichen Aussage von Ehrlich nicht folgen, dass es zwei gegeneinander wirkende körpereigene Systeme gibt. Nachdem es zu einer Zahl von eigenartigen Erkrankungen von Menschen kam, wurde diese Idee noch einmal aufgegriffen. Bei diesen Erkrankungen handelt es sich Multiple Sklerose, Diabetes und rheumatöse Arthritis. Wie die Wissenschaftler bald herausfanden, liegt der Ursprung hier in den weißen Blutkörperchen (CD4+T). Normalerweise fungieren diese als so genannte Wächter im Immunsystem. Es wurde aber festgestellt, dass genau dieselben auch gegen das Immunsystem arbeiten können. Ein weiterer Punkt, bei dem Ehrlich richtig lag, waren die so genannten T-Zellen, die eine Subpopulation der CD4+T darstellen. Diese sind für das Blockieren von anormalen Verhalten des Immunsystems zuständig. Wissenschaftler weltweit sind deshalb der Überzeugung, dass das Erforschen dieser T-Zellen und das Beherrschen dieser, einen Meilenstein in der Bekämpfung der oben genannten Erkrankungen darstellen. Hinzu kommt die wirksame Bekämpfung der damals noch nicht existenten HIV Erkrankung. Daher konzentrieren sich weltweit Unternehmen auf die Erforschung von Verfahren und Produkten hierfür. Ein Unternehmen, das in diesem Bereich hervorragende Ergebnisse erzielt hat, und das ein sehr starkes Management-Team zusammengestellt hat, ist das amerikanische Unternehmen, Immune Response Corp. (WKN: 765803 / ISIN: US45252T2050).
NeuroVAX™ zielt auf die Einstellung bzw. Verlangsamung der Symptome der Multiplen Sklerose. Das Produkt basiert auf der patentgeschützten T-Zellen Rezeptor-Technologie. Während der klinischen Tests wurde bei kaum einem der Patienten Nebenwirkungen festgestellt. Hierbei wurde eine Stärkung der so genannten FOXP3+ Zellen festgestellt, die für die Schwächung der pathogenen T-Zellen verantwortlich sind. Diese wiederum sind für Multiple Sklerose verantwortlich.
Das Produkt basiert auf dem patentgeschützten REMUNE® und stellt eine Weiterentwicklung dar. Es hat in sicheren und immungenetischen Testverfahren hervorragende Ergebnisse geliefert. Es ist gegenüber REMUNE® aussichtsreicheres Produkt, das auf der Kombination von inaktiven Antigenen und dem synthetischen Rezeptor TLR-9 basiert.
One company that has a rather positive outlook, but is considerably smaller than BGEN and IMNX is Alexion Pharmaceuticals (ALXN), which has a market cap of about $935 million and relatively attractive product pipeline. ALXN is making good advances in a variety of different areas, not just MS. The company is doing research into cardiovascular care, as well as various autoimmune disorders. Its lead investigational drugs are currently in clinical trials for cardiopulmonary bypass, myocardial infarction, rheumatoid arthritis, and nephritis. But that is not all; ALXN is also investigating other autoimmune diseases, like lupus, psoriasis, and MS.
IMNR has a market cap of about $230 million. The company's lead product is REMUNE, for treating HIV, and it has teamed up the Agouron Pharmaceuticals, a division of pharmaceutical giant Warner-Lambert. As I mentioned in that article, unlike many anti-viral therapies that try to prevent the virus from replicating, REMUNE is believed to stimulate the immune system. Studies have demonstrated that REMUNE, when used in combination with anti-viral drug therapy, stimulates cytotoxic T lymphocytes (CTLs, or killer T-cells), which are the white blood cells that, according to IMNR, are capable of killing HIV-infected cells. IMNR is also doing research into various autoimmune disorders, and has investigational products in clinical trials for treating such afflictions as rheumatoid arthritis and psoriasis, in addition to MS.
Immunomedics' Humanized anti-CD20 Antibody Effective in Severe Lupus
Immunomedics, Inc. (Nasdaq: IMMU) today announced that a patient with severe resistant systemic lupus erythematosus (SLE), including the development of human antichimeric antibodies (HACA) against rituximab, responded to the Company's new humanized anti-CD20 monoclonal antibody.
"To the best of my knowledge, this is the first case of a patient with severe SLE no longer responding to the chimeric rituximab anti-CD20 antibody being responsive to an investigational humanized anti-CD20 monoclonal antibody," stated Dr. David A. Isenberg at the Centre for Rheumatology, Department of Medicine, University College in London, in a just published Letter to the Editor in the journal, Rheumatology. "This case report not only demonstrates that B-cell depletion is effective in the management of patients with severe resistant SLE, but that in the presence of host antibody against the chimeric anti-CD20 monoclonal antibody, rituximab, the humanized anti-CD20 antibody appeared to be effective," added Dr. Isenberg. Immunomedics provided its proprietary antibody on a compassionate use basis.
"We are pleased that our humanized CD20 antibody is effective in the management of severe SLE. This corroborates the thesis that SLE is a B-cell mediated disease and that B-cell targeted antibodies may be active in the treatment of this debilitating illness," commented Ivan D. Horak, M.D., Executive Vice President, Research and Development, and Chief Scientific Officer of Immunomedics.
"The CD20 antibody is the second antibody in our clinical portfolio to have demonstrated activity in lupus patients. We expect to launch two pivotal phase III trials in the first half of calendar year 2005 in patients with moderate to severe lupus with our lead B-cell targeted antibody, epratuzumab," remarked Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics.
Immunomedics is a biopharmaceutical company focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We believe that our portfolio of intellectual property, which includes approximately 90 issued patents in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies.
This release, in addition to historical information, contains forward- looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with new product development (including clinical trials outcome and regulatory requirements/actions), competitive risks to marketed products and availability of financing and other sources of capital, as well as the risks discussed in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2004. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
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
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
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.
About The Immune Response Corporation
The Immune Response Corporation (Nasdaq: IMNR) is a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis (MS). The Company’s HIV products are based on its patented whole-killed virus technology, co-invented by Company founder Dr. Jonas Salk, to stimulate HIV immune responses. REMUNE®, currently in Phase II clinical trials, is being developed as a first-line treatment for people with early-stage HIV. We have initiated development of a new immune-based therapy, IR103, which incorporates a second-generation immunostimulatory oligonucleotide adjuvant and is currently in Phase I/II clinical trials in Canada and the United Kingdom.
The Immune Response Corporation is also developing an immune-based therapy for MS, NeuroVaxTM, which is currently in Phase II clinical trials and has shown potential therapeutic value for this difficult-to-treat disease.
Please visit The Immune Response Corporation at www.imnr.com
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 REMUNE®, NeuroVaxTM 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 REMUNE®, NeuroVaxTM 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 REMUNE®, NeuroVaxTM or IR103 in preclinical trials and/or earlier clinical trials. These risks, among others, are 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, 2004, and its subsequent Quarterly Reports 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. NeuroVaxTM is a trademark of The Immune Response Corporation