Institute History – 1993 to 2009

In the early years of the AIDS pandemic, patients afflicted with HIV-associated neuropathic pain sought Dr. Michael J. Scolaro’s help in the pain management clinic at St. Vincent Medical Center, Los Angeles. Concerned by their overwhelming medical needs – and growing numbers – Dr. Scolaro changed the focus of his practice from neuropsychiatry to the treatment of patients with HIV infection. In 1986, before the introduction of AZT, he received the first FDA physician-sponsored combined antiviral and immune- modulator HIV protocol, consisting of a combination of two agents ( Ribavirin---an antiviral drug, currently approved for Hepatitis C infection produced by Viratek, and Thymopentin TP5, a synthetic thymic immune hormone produced by Johnson and Johnson's Ortho division).

In 1993, Dr. Scolaro founded the Anti-Viral Research Institute as a non-profit research foundation initially dedicated to exploring the potential for immunoliposomal targeting of cells infected with HIV. With a team of collaborators in clinical medicine and research science, the foundation expanded its interest to include studying and treating the multiple infectious diseases, medical complications, and cancers associated with immune suppression. In 1996, to reflect the Institute’s expanded vision and mission, the Board changed its name to Let There Be Hope Medical Research Institute.

The focus of liposome-targeted research for the Institute began earlier, when Drs. Sean Sullivan, Director of Research, and Michael Scolaro began their collaboration in the late 1980s. At that time, Dr. Sullivan, a scientist with Vestar with a long history of research in liposome targeting technology, and Dr. Scolaro collaborated in an early study on the use of Liposomal- encased Daunorubicin in Kaposi’s Sarcoma in AIDS patients.

Soon afterwards, they teamed with Dr. Robert Gieseler in a laboratory investigation on the inhibition of HIV-1 proliferation with liposome-encapsulated antisense and sense to a vital gene encoded in HIV DNA. With Peyman Javaherbin, M.S., as the Institute’s laboratory director and several post-doctoral fellows from the U. of Goettingen, Germany, including Dr. Thomas Gabryziak, M.D., PhD, and Dr. Joerg Ruppert, PhD, as well as a team of scientists from Vestar, they completed their first major work on inhibition of HIV viral replication by immunoliposomal targeting of infected CD4 cells, published in 1992.

This study provided the ground work for the Institute’s subsequent development of nanocarriers to target immune cells intracellularly with high site-specificity and affinity for Hepatitis C and HIV infected reservoir cells, and its current interest in cutting-edge immune therapies in a variety of cancers.

Throughout the 1990s, the Institute’s clinical research studies were managed by Research Assistant, Ms. Bil-Quis Al-Farouk, R.N. In 2000, Dr. Robert Gieseler, PhD. was appointed Chief Scientist and Immunologist, bringing a team of outstanding research associates, including molecular biologist Guido Marquitan, M.S. Ph.D., and Research Associates Michael Hahn, B.A. and Tanja Wader, M.S. In 2002, as pre-clinical research activities in targeting cells of the immune system was advancing, Dr. Rodney J.Y. Ho, Ph.D., and Sonya Snedecor, Ph.D., joined the team as consultants scientists.

In addition to the many individual donors and active Board Members funding the Institute’s research, we have been generously supported by private foundations and corporations. Since its beginnings, LTBH has received more than $2 million in donations, all of which has been used exclusively for research activities, scientist salaries, research laboratory rent, equipment, supplies, and administrative overhead. Officers, administrative staff, and members of the Board are not compensated and have donated their time and tireless efforts with generosity and compassion for our goals and our patients.

In 2007, the Board of Directors changed its focus from in-house laboratory research to out-sourced pre-clinical and clinical studies, utilizing our patented nanocarrier targeting technology. All laboratory and basic science R&D is currently outsourced to international academic and research institutions as well as biotechnology companies with whom we have established collaborative research relationships over the past decade, and whose interests are synergistic with our clinical therapeutic goals in infectious diseases, cancer, and autoimmunity.

With continued progress in the development and refinement of its core targeting technologies, LTBH has now expanded its clinical goals to enhancing vaccine efficacy for various endemic infectious and autoimmune diseases, as well as innovative immune modulator approaches for chemotherapy resistant cancers in human and veterinary medicine.

Institute Achievements

Beginning in the early 1990s, our team of scientists and consultants conducted Research studies at the LTBH laboratories, culminating in 2004 and 2005 with two U.S. and International patents directed at site-specific intracellular targeting of key immune cells, as well as evolutionarily conserved families of cells.

With regard to our initial interest in the manner by which the HIV and Hepatitis C viruses establish long-term reservoirs that evade eradication by current gold-standard antiviral therapies, we directed our studies at the development of a nanocarrier, encapsulating a plant-derived antiviral compound, to specifically target immune cell-surface receptors identical to those used by viruses for gaining cell entry. The nanocarrier has been embedded with a sugar molecule on its surface, similar to the non-mutating viral envelope carbohydrates required for attachment to immune reservoir cells. The nanosphere thus gains cellular entry by the same pathway employed by the virus, thereby entering the identical intracellular compartments where long-term dormant infectious viruses reside. Within these compartments, the nanocarrier releases its antiviral contents which attaches and binds to the dormant virus surface carbohydrates, resulting in viral death and an agglutinated complex which is then recognized by intracellular enzymes and subjected to proteolysis without harm to the cell itself. Thus, this technology offers the potential for complete elimination of the viral reservoirs of HIV and Hepatitis C.

An extraordinary benefit of this technology is the promise it now holds for the similar mode of elimination and control of a host of other chronic viral and bacterial diseases including Ebola Virus and resistant strains of Tuberculosis. Because of the similar carbohydrate molecular mechanism of cell entry required by each of these different pathogens (which can never mutate), we have essentially discovered their "Achilles Heel".

Because our targeting methodology offers potential therapeutic immune modulation of key immune cells as well as evolutionarily conserved families of cells, in 2009 the proprietary technology was licensed by LTBH to Rodos BioTarget, GmbH a biotechnology company in Hannover, Germany to fund and spearhead the preclinical and clinical development of treatments for Hepatitis C, HIV, cancer immune modulator therapies, allergy, autoimmune diseases, and vaccine enhancement for endemic infectious diseases such as Malaria and Leishmaniasis. Since then Rodos BioTarget received a non-exclusive license from the PHS/NIH to evaluate the clinical and commercial potential of one of their proprietary novel antivirals which has been encapsulated into our nanocarrier for targeted delivery to HIV and HCV reservoir cells.

LTBH currently is engaged in developing a targeted immune modulator treatment for chemotherapy/radiation resistant cancers for veterinary and human application.

(See Current Collaborative Projects)