TAMPA, Fla., April 29, 2008 — Quantum Immunologics, Inc. ("QI") announces the commencement of a Phase I/II clinical trial to assess the safety and efficacy of a novel anti-cancer vaccine/immunotherapy that will be used on patients with Stage IV advanced breast cancer. Patients accepted into the study have previously failed to respond to conventional therapy consisting of surgery, radiation and/or chemotherapy. QI has commissioned the study to be done by the original immunobiologists who developed the experimental immunotherapy. The clinical trial will be part of an FDA-authorized or effective investigator-sponsored Investigational New Drug application (IND).
This immuno-therapeutic experimental "vaccine" developed by scientists at the University of South Alabama (USA) is intended to activate the body's immune system against a cancer-specific protein to destroy the cancer cells. This immunizing protein, called the Oncofetal Antigen (OFA) or immature Laminin Receptor Protein (iLRP), is a universal cancer antigen or protein expressed in all human cancer types tested by the USA scientists thus far. Notably, this specific protein is not expressed on normal cells and tissues and thus is cancer-specific according to available assays.
Those patients with disseminated breast carcinomas and meeting the clinical trial entrance criteria will be treated under the above referenced IND at the Southern Cancer Center (SCC) in collaboration with clinicians at the Providence Cancer Center and other local oncology centers in and around Mobile, Alabama.
The investigators will collect from each patient's blood a white blood cell population called Dendritic Cells (DC). These cells are then exposed in vitro to replicated iLRP, cultured, and reintroduced into the patient via subdermal injection. The hope is that iLRP-sensitized DC will then recognize iLRP as a foreign protein or antigen on cancer cells and, when reintroduced into the body, will then, in turn, sensitize or introduce another group of immune cells known as T-killer lymphocytes, to the iLRP protein. The function of T-killer cells is to recognize foreign substances and initiate their destruction. Once these killer cells are activated against the iLRP protein on the cancer cells, it is further hoped that they will overwhelm and destroy the patients' breast cancer.
In a previous study recently undertaken in Austria, eleven advanced renal cell carcinoma patients who failed conventional therapy were treated with this type of immunotherapy. These patients developed a cytotoxic response secondary to activation of their T-killer cells against the iLRP protein using the same type of technique as in the present study. Five of the 11 patients are still alive with a median follow up of 46.7 months (range 33-54 months). The one-year survival rate was 90%; two-year survival rate – 54%; three-year survival rate – 45%. Notably though, the patients suffered no serious side effects from the therapy where most of the effects were flu-like symptoms secondary to the desired immune response. This study is designed to determine whether breast cancer patients will respond similarly and without toxicity.
This latest breast cancer study is the culmination of over 20 years of laboratory study and research of OFA with the support of the National Institutes of Health, including National Cancer Institute. The three senior immunobiologists, Drs. Joseph Coggin, Jim Rohrer and Adel Barsoum of the Department of Microbiology and Immunology at the University of South Alabama, will collaborate with the primary investigator, Dr. Paul Schwartzenberger, M.D., an SCC oncologist.
About Quantum Immunologics, Inc.
QI was formed for the sole purpose of developing, implementing and distributing new advanced levels of designer therapeutic treatments and diagnostic tools including all of the patents and intellectual properties acquired from USA by Venture Research Institute, Inc. (a southern California based private investment club) and its sister company, Investors Medical Fund, LLC. QI's mission is to foster the development and support for these and other technologies that are complementary to its current portfolio of patented intellectual properties that are focused on immune diseases and disorders. Mr. Chuck Broes, QI's CEO, states that they are currently assembling additional top scientists and professionals in the industry to carry out its mission. Mr. Broes further states that the philosophy of QI is to develop partnerships with other firms which are recognized leaders in their respective fields to implement the mission.
To learn more, visit .
Contacts:
For QI, Chuck Broes:
813-849-7885
2701 Rocky Point Dr., Ste. 325, Tampa, FL 33607
For USA/SAMSF, Dr. Paul Schwartzenberger, Chief Oncologist:
251-401-1975
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