According to Dr. Maria Gordon, Chief Medical Officer of Epeius, “What this means, in terms of clinical development, is that the Rexin-G product, with its advanced GMP manufacturing, bio-processing, and final formulation, meets rigorous FDA standards for obtaining a marketing license in the future; and that Epeius Biotech can now proceed with its strategic, diversified Phase 3 drug development program for pancreatic cancer, osteosarcoma and soft tissue sarcoma.”

In addition to these high-priority programs, Rexin-G has demonstrated significant anti-tumor activity in chemotherapy-resistant breast cancer, hormone-refractory prostate cancer, ovarian cancer, squamous cell carcinoma, and certain hematologic malignancies, such as large B-cell lymphoma.

Rexin-G® was granted accelerated approval for the treatment of all chemotherapy-resistant solid malignancies in the Republic of the Philippines in 2007. In the U.S.A., Rexin-G gained Orphan Drug Designation and market protections from the FDA for pancreatic cancer in 2003, followed by Orphan Drug Status for both osteosarcoma and soft tissue sarcoma in 2008. More recently, Epeius Biotechnologies completed a series of Phase 1 and Phase 2 clinical trials in the U.S., establishing the thresholds for bioactivity and dose-dependent efficacy for Rexin-G against a number of otherwise intractable cancers, as well as the product’s overall safety over extended survival times and a notable lack of either safety issues or dose-limiting toxicities.

With these development-stage accomplishments at hand, Epeius is gearing up to open a series of pivotal studies for both pancreatic cancer and sarcomas in the U.S., while continuing to advance the clinical utility and market development of Rexin-G worldwide.

With the completion of the enabling platform development and the clinical validation of its foremost oncology product, Epeius Biotechnologies continues to lead the field of genetic medicine with the development of its product pipeline, which includes Reximmune-C, a tumor-targeted gene delivery system for “personalized” cancer vaccinations, administered to stimulate a long-lasting anti-tumor immunity.

For further information about Epeius Biotechnologies, its lead products, and its clinical trials, please contact Erlinda M. Gordon, M.D., at egordon@epeiusbiotech.com .

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This latest support for the clinical advancement of Rexin-G comes from the Qualifying Therapeutic Discovery Project (QTDP) program, created as a component of the Patient Protection and Affordable Care Act of 2010 to support projects that are determined by the HSS to have significant potential (i) to develop innovative new treatments to address major unmet medical needs, (ii) to reduce long-term health care costs, (iii) to represent significant medical progress toward an eventual treatment/cure for cancer, (iv) to advance U.S. competitiveness in the fields of life science and medical technologies, and (v) to create and/or sustain well-paying jobs in the United States.

This meritorious tranche of U.S. Government support for Rexin-G, the world’s first and, so far, only targeted injectable genetic medicine for cancer that has been validated in clinical trials, represents the latest formal declaration of the potential importance, competitiveness, and overall merit of the platform of highly-advanced molecular biotechnologies and nanotechnologies embodied in this targeted injectable anticancer agent.

“We are very pleased with this formal recognition and support of our medical mission, for it represents a continuing commitment to develop the high-value products and intellectual properties of this company for the benefit of all,” said Lina Kabayan, Epeius CFO who spearheaded this latest grant submission.

From the first National Science Foundation (NSF) and NIH grants awarded to the founders of Epeius Biotechnologies, to the American Heart Association (AHA) which provided funding to support the cardiovascular targeting technologies, to the Office of Orphan Products Development (OOPD) which provided funding for the first clinical trials in the U.S., and which ultimately granted Orphan Drug Status to Rexin-G for three separate clinical indications (pancreatic cancer, soft tissue sarcoma, and osteosarcoma), to the U.S. FDA which granted Fast Track Status to Rexin-G for chemotherapy-resistant pancreatic cancer, the continuing federal support for these vital medical technologies is a testament that basic science and innovation in the service of medicine is still alive and well in America.

About Epeius Biotechnologies Corporation:
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company that is bringing the latest advancements in genetic medicine to the cancer patient with the development and commercialization of its leading oncology products and its tumor-targeted delivery systems. Rexin-G® is currently approved for the treatment of all chemotherapy-resistant solid tumors by the Philippine FDA.

Learn more about our lead products and/or our pipeline of proprietary biotechnologies at: www.epeiusbiotech.com. For recent papers, expert reviews, clinical reports in oncology and molecular therapy, see the “Publications” section.

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Based on the adaptive Phase I/II study design, which included an FDA allowance for surgical intervention to be added to the treatment protocol in cases where repeated Rexin-G infusions had served to control the cancer and halt disease progression, the report describes the use of Rexin-G as both neoadjuvant therapy (before surgery) and as adjuvant therapy (after surgery) to prevent post-surgical spread and disease recurrence. Remarkably, the excised tumor(s) showed the process of Rexin-G accumulation within the tumors, as well as the molecular mechanisms of tumor cell destruction, with an unprecedented level of histological high-definition.

The landmark paper, published in the latest issue of Oncology Reports (Open Access, 24: 829-833, 2010) demonstrates the physical accumulation of the intravenous Rexin-G nano-medicine within the metastatic tumor prior to its surgical excision.

It additionally reveals the selective accumulation of the Rexin-G nanoparticles on the surfaces of the target cells, i.e., pancreatic cancer cells and their proliferative vasculature, which is a distinctive property of the tumor-targeted nanotechnology platform. Using elegant immunohistochemistry to identify the process of active cell death (apoptosis) enforced by Rexin-G, the molecular mechanisms of precision tumor-targeting and selective cell death have never been more vividly displayed.

It bears mentioning that the pancreatic cancer patient highlighted in this histological study is currently in surgical remission, with no new lesions during Rexin-G treatment and no disease recurrence going on six months after the Rexin-G / Surgical Excision / Rexin-G treatment combination.

About Epeius Biotechnologies:

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company that is bringing the latest advancements in genetic medicine to the cancer patient with the development and commercialization of its leading oncology products and its tumor-targeted delivery systems. Rexin-G(R) is currently approved for the treatment of all chemotherapy-resistant solid tumors by the Philippine FDA.

To learn more about our lead products and/or our pipeline of proprietary biotechnologies, please visit us at http://www.epeiusbiotech.com . For recent papers, expert reviews, clinical reports in oncology and molecular therapy, etc., see the “Publications” section.

Plain text copy of press release (and media contact)

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STORY REFERENCES: To Reach, Perchance to Kill the Cancer: A Soliloquy from Epeius Nanotechnologies Opposes that ‘Sea of Troubles’, Oncology Reports, Rexin-G in chemo-resistant metastatic pancreatic cancer, targeted genetic medicine, histological study, U.S. Phase I/II clinical trials, biotech, pharma, cancer research, treatment protocol, oncology products, molecular therapy, Erlinda M. Gordon, M.D.

As the development of its lead oncology product advances in the clinic towards regulatory approval, the critical proofs-of-principle, i.e., definitive demonstrations of overall safety and single-agent efficacy in clinical trials, serve as the scientific and innovative basis for attaining additional patent protections in the emerging field of tumor-targeted biologics. Indeed, Epeius Biotechnologies has accumulated more than 150 issued/allowed/granted patents in the area of genetic medicine, including more than 40 pending applications.

Furthermore, the U.S. FDA has recently granted Orphan Drug status to Rexin-G, the company’s lead product, for three separate clinical indications based on formal evaluations of clinical safety and potential efficacy, which provides additional market protections and economic incentives pertaining to such a significant and yet unmet medical need as the treatment of chemotherapy-resistant cancers.

Exhibiting broad-spectrum anti-cancer activity against many otherwise intractable cancers, Rexin-G has demonstrated a number of first-in-class, best-in-class characteristics: (1) The tumor-targeting properties of the gene delivery platform are profound, capable of seeking-out, accumulating-in, and halting-the-progression-of widespread cancers by means of simple intravenous infusions. (2) The broad-spectrum anti-cancer activity is achieved “by design”, as the genetic payload is focused on a critical locus of cellular growth control and tumor suppression. (3) Years of progressive clinical trials have advanced the field by establishing cumulative safety (with no dose-limiting toxicities), practical pharmacological thresholds, quantitative dose-response relationships, and clinical infusion protocols which optimize patient benefits, including significant survival benefits. (4) Equally important are the advancements in biopharmaceutical science that provide for greater purities, potencies, GMP productivity, and economies-of-scale, and which translate into more-affordable treatments for cancer patients. All in all, it seems that Small, Smart, and Stealth may turn out to be a very cool hand to grasp, and to hold on to.

About Epeius Biotechnologies:

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its leading oncology products and its tumor-targeted delivery systems. Rexin-G is currently approved for the treatment of all chemotherapy-resistant solid tumors by the Philippine FDA. To learn more about our lead products and/or our pipeline of proprietary biotechnologies, please visit us at http://www.epeiusbiotech.com .

For recent papers, expert reviews, clinical reports in oncology and molecular therapy, etc., see the “Publications” section on our website.

News Source: Epeius Biotechnologies Corporation :: This press release was issued by Send2Press® and is Copyright © 2010 Neotrope® News Network – all rights reserved.

STUDY SUMMARY: The goals of the study were to evaluate the over-all safety and efficacy of intravenous infusions of Rexin-G, a tumor-targeted retrovector bearing a cytocidal anti-cyclin G1 construct, in chemo-therapy-resistant bone and soft tissue sarcoma. A Phase II “run-in” component was integrated by adaptive design by continuing treatment if the patient had Grade 1 or less toxicity. Thirty-six patients received escalating doses of Rexin-G intravenously three times a week for four weeks. Analysis of safety showed no dose-limiting toxicity and no cumulative toxicity in patients treated with Rexin-G monotherapy for up to 2 years. Analysis of efficacy revealed a dose-dependent relationship between progression-free survival/overall survival and Rexin-G dosage (p = 0.02 and 0.002 respectively) which was significant at the 5% statistical level by the log-rank test. Median survival was 11.5 months and one-year survival was 40% in the high-dose groups. These findings indicate that intravenous Rexin-G is safe and well-tolerated with no cumulative toxicity, and that Rexin-G controls tumor growth, and prolongs progression-free survival and over-all survival times in a dose-dependent manner in patients with chemotherapy resistant bone and soft tissue sarcoma.

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.

News Source: Epeius Biotechnologies Corporation :: This press release was issued by Send2Press® and is Copyright © 2010 Neotrope® News Network – all rights reserved.

STUDY SUMMARY: The goals of the Phase I/II study were to evaluate the over-all safety and efficacy of intravenous infusions of Rexin-G, a tumor-targeted retrovector bearing a cytocidal anti-cyclin G1 construct, in gemcitabine-resistant pancreas cancer. A Phase II “run in” study was integrated by adaptive design wherein additional cycles were given if the patient had Grade 1 or less toxicity. Twenty patients received escalating doses of Rexin-G intravenously three times a week for four weeks. Analysis of safety showed no dose-limiting toxicity and no cumulative toxicity in patients treated up to 18 months. Analysis of efficacy in evaluable patients revealed significant tumor responses: 100% tumor control rate (TCR) was observed at all doses tested, and 24% partial response (PR) or complete response (CR) by RECIST criteria in the high dose cohorts. A dose-dependent relationship between overall survival and Rexin-G dosage was demonstrated, which was significant at the 5% statistical level by log rank test (p = 0.03). Median survival was 9.3 months and one-year survival was 33% in the high dose groups. Remarkably, one patient exhibited a complete response with the (adaptive) repeated cycles, attaining clinical remission after 9 months of continued treatment with Rexin-G. These findings indicate that intravenous Rexin-G is safe and well-tolerated with no cumulative toxicity and that Rexin-G controls tumor growth and may prolong over-all survival in a dose-dependent manner in patients with gemcitabine-resistant pancreas cancer.

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 .

News Source: Epeius Biotechnologies Corporation :: This press release was issued by Send2Press® and is Copyright © 2010 Neotrope® News Network – all rights reserved.

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 .

News Source: Epeius Biotechnologies Corporation :: This press release was issued by Send2Press® and is Copyright © 2010 Neotrope® News Network – all rights reserved.

The second article, entitled “Noteworthy Clinical Case Studies in Cancer Gene Therapy” (Intl. J. Oncology, April, 2010) highlights important aspects of Rexin-G bio-pharmacology, as this tumor-targeted vector advances as an efficacious anti-cancer agent. What the reader will gain: These remarkable case studies, in and of themselves, reveal important aspects of the molecular pharmacology, advanced clinical protocols, refinement of patient monitoring, expanding treatment options, and strategic medical approaches to patient care that exemplify and thereby extend the established principles of pathotropic targeting and cancer gene therapy to a new generation of clinical practitioners. Take home message: Each case study, in an otherwise intractable cancer, “teaches” a vital lesson in the emerging praxis of cancer control.

Finally, the third article comes in the form of a Mini review entitled “Nanoparticles and the Immune System” (Endocrinology, Feb, 2010) co-authored by members of the FDA Center for Drug Evaluation and Research, Office of Pharmaceutical Science, and the Nanotechnology Characterization Laboratory of the National Cancer Institute. What the reader will gain: This astute review of medical nanotechnology aptly describes the concept of targeted delivery of Rexin-G followed by Reximmune-C as a two-tier complementary approach aimed at both tumor eradication and personalized cancer vaccination. That is, the first step involves the use of Rexin-G to target and control the progression of metastatic cancer, whereas the second step employs Reximmune-C to induce a localized cancer immunization. Take home message: This is a commendable and timely review of these first-in-class, best-in-class tumor-targeted anti-cancer agents, which may supersede more cumbersome approaches to personalized cancer vaccinations.

About Epeius Biotechnologies:

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its leading oncology products and its tumor-targeted delivery systems. To learn more about our recent publications and/or proprietary biotechnologies, please visit www.epeiusbiotech.com .

News Source: Epeius Biotechnologies Corporation :: This press release was issued by Send2Press® and is Copyright © 2010 Neotrope® News Network – all rights reserved.