http://www.epeiusbiotech.com/
Rexin-G® - Tumor-Targeted Injectable Genetic Medicine
About Rexin-G®
Scientists at Epeius Biotechnologies have developed the high-technologies that can deliver a new class of powerful biological agents directly to tumors that have spread throughout the body (metastatic cancer). The lead product, Rexin-G, is a sophisticated gene delivery vehicle (or vector); a tumor-targeted nanoparticle that is programmed to deliver a tumor-killing designer gene precisely where it is needed most. Rexin-G has been validated in international clinical trials, where it is shown be highly active against a broad spectrum of chemo-resistant tumor types, causing tumor shrinkage in patients suffering from metastatic cancer, without causing dose-limiting toxicity or organ damage.
Technically, Rexin-G is a matrix-targeted nanoparticle that seeks out the biochemical hallmarks of pathology (pathotropic targeting), accumulates to high levels in tumors, and delivers a cytocidal (lethal) gene construct: a dominant-negative construct of the human Cyclin-G1 gene, a pivotal cell cycle control element. The capsule containing the therapeutic dnG1 gene is based on a murine retroviral core, which is devoid of viral genes and has been rendered certifiably replication incompetent—that is, it capable of delivering a therapeutic gene once, and only once. The integral tumor-targeting function is indeed profound, in that it is capable of penetrating primary and metastatic cancers, as well as cancers within the lymphatic system, with high efficiency, within a matter of hours, which represents the half-life of the active anti-cancer agent.
Cancer patient beating the odds
By Dan Abendschein, Staff Writer
Posted: 05/13/2009 08:25:05 PM PDT
Last summer, Ruth Oliver was prepared to tell her friends and family goodbye and live out in peace the seven months her doctor had estimated she had left.
Today, she says she feels healthier than she did before she was diagnosed with pancreatic cancer, thanks to a local medical research team that has come up with a new treatement.
"They've extended my life and given me a better quality of life," said Oliver, a 73-year-old North Carolina native who is now living in Southern California to receive treatment.
The drug, called Rexin-G, was developed by a San Marino-based firm. It is now going through the clinical trial phase and has not yet been approved by the Federal Drug Administration.
The treatment, which is administered by intravenous drip three times a week, is designed to minimize tumors that chemotherapy cannot destroy.
Oliver has several such tumors: she may never be rid of them, but so far, the drug has helped keep them under control.
A career mortgage broker in the Durham area, Oliver was generally healthy until one Saturday in 2006 she found herself extremely itchy - a maddening symptom that bothered her to the point of going to the emergency room. Her doctors diagnosed her with pancreatic cancer.
She had surgery for her tumors and then had several bouts of chemotherapy and raditation treatements which left her exhausted, but still not rid of cancer.
"I could hardly lift my foot off the floor and walk, I was so tired," said Oliver. Last summer, her doctor in Durham noted that the latest chemo session still had not rid her of tumors, and that she would not live for more than six to seven months. But he suggested she investigate new cancer treatments being developed.
Oliver did extensive Internet research, and finally came across Epeius Biotechnologies, the San Marino firm that developed Rexin-G. She gets her treatment at a Santa Monica clinic, and is now living in Marina Del Rey.
The drug is part of a new kind of medical treatment called gene therapy. The Rexin-G treatment involves a specially-designed gene that interacts with cancerous cells.
Dr. Maria Gordon, the co-founder of Epeius who helped develop the drug, describes it as a "guided missle."
"It knows where to go," said Gordon. "It targets the cancer cells and gives them a self-destruct order."
The drug, she said, tells the cancer cells to stop reproducing, stopping their growth and their influence on the body.
The gene in the drug is designed to move into areas where there are cancerous cells, and to avoid areas where there aren't any.
It could be used by patients with all kinds of cancer , said Gordon.
The drug has testing status from the FDA, and Oliver is one of the patients undergoing clinical trials to see if it is effective.
Living in California has been an adjustment for Oliver, but she has visited the area before and is enjoying the weather, and the chance to live somewhere new.
Her apartment is within walking distance of the beach, something Oliver takes advantage of. "I'm just glad to have a chance to live in such a beautiful area," said Oliver, of her new home in Southern California.
dan.abendschein@sgvn.com
(626) 962-8811, Ext. 4451
Drugs and Pharmaceuticals News
PRESS RELEASE:
Tumor-Targeted Nanoparticle-based Gene Delivery Provides Evidence of Therapeutic Vaccination in Patients with Metastatic Cancer (ASCO 2010)
Mon, 24 May 2010, 13:06:41 EDT
SAN MARINO, Calif. (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation (
www.epeiusbiotech.com) today announces the clinical results of the study entitled "A Phase I/II Study of Intravenous Rexin-G and Reximmune-C for Cancer Immunotherapy: The GeneVieve Protocol" at the ASCO Annual Meeting on June 6, 2010. The presentation will be made by Dr. Jorge G. Ignacio, Chairman of the Cancer Institute and Bioethics Committee-Philippine General Hospital, and Principal Investigator of the study.
SUMMARY: Rexin-G and Reximmune-C are tumor-targeted retrovectors bearing a cytocidal anti-cyclin G1 construct and a controllable GM-CSF expression construct, respectively. The working hypothesis underlying this two-tier complementary approach to tumor eradication and cancer vaccination is that a personalized vaccination of a patient against his or her own specific cancer can be achieved by combining (1) a targeted vector bearing a tumoricidal payload, i.e. Rexin-G, with (2) a targeted vector bearing a potent immuno-stimulatory (GM-CSF) gene, i.e. Reximmune-C. In this model, Rexin-G is first administered to control tumor growth and expose neoantigens within the tumor microenvironment, followed by defined pulses of Reximmune-C, intended to recruit the patient's immune cells into these lesions, thereby prompting immunologic activation, recognition of tumor neoantigens, and induction of a beneficial antitumor immunity. The initial results of a Phase I/II dose escalation study showed that, in addition to the expected tumoricidal effects of Rexin-G, histopathologic examination of biopsied tumors from patients with a diversity of cancer types revealed targeted nanoparticle delivery, GM-CSF transgene expression, and localized immune responses within the lesions. Importantly, no circulating GM-CSF protein was detected and no dose limiting toxicity was observed throughout the treatment period. Moreover, there appears to be a significant survival benefit which suggests that this two-tier approach has considerable merit as a therapeutic vaccine.
About Epeius Biotechnologies:
Epeius Biotechnologies Corporation (
www.epeiusbiotech.com) is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its lead products, Rexin-G and Reximmune-C, and its high-performance gene delivery systems. To learn more about these agents and/or ongoing clinical trials, please contact Dr. Erlinda M. Gordon at egordon @ epeiusbiotech.com .
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