Send2Press Newswire

FDA Grants Epeius Biotechnologies' Rexin-G A Third Orphan Drug Designation, This Time for the Treatment of Soft Tissue Sarcomas

Tue, 08 Jul 2008 18:01:25 GMT

SAN MARINO, Calif., July 8 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced that Rexin-G has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of all soft tissue sarcomas. This latest approval is the third clinical indication for which Rexin-G has been formally recognized by the FDA in the United States. This latest approval for Rexin-G validates the company's remarkable strategy of addressing a global unmet medical need by caring for one individual patient, one particular type of tumor, one otherwise intractable cancer at a time.

The clinical development of Rexin-G worldwide has been equally remarkable. Beginning with the most serious and life-threatening forms of pancreatic cancer, Rexin-G has demonstrated unprecedented single-agent efficacy in metastatic cancers of the colon, breast, skin, lung, and bone in a progressive program of expanded access that continues to achieve historic milestones. Eschewing any trappings of personal accomplishment, Epeius gives credit to the dedication and efforts of the many pioneering oncologists, the progressive medical institutions, and the conscientious regulatory agencies who have all served to guide Rexin-G, with its elegant tumor-targeting nanotechnologies, to the bedside. Most recently, Rexin-G has been approved in the Philippines for the treatment of all solid tumors that are refractory to standard chemotherapies.

In addition to developing the first and so far only tumor-targeted genetic medicine that has been validated in the clinic, Epeius Biotechnologies has assumed the daunting responsibilities of advancing these enabling platform technologies safely and effectively through an arduous array of regulatory hurdles and medical proofs-of-principle that are required for a radically new medicine. Initial Phase I safety studies established the general safety of Rexin-G, followed by Phase I/II efficacy studies where optimal clinical protocols were established for each particular type of tumor.

The importance of these progressive dose-escalation studies-which clearly establish safety before escalating to more potent tumoricidal dose levels-is of primary concern in the development of a new genetic medicine like Rexin-G. Moreover, the establishment of a functional dose-response relationship is of fundamental significance, not only in terms of basic pharmacology, but in establishing the physiological mechanisms-of-action that are of major importance in determining the predictability of a new anti-cancer agent and ultimately in gaining full regulatory approval for Rexin-G in the United States.

Based on the scientific and medicinal merits of Rexin-G, as well as the rarity, seriousness, and lack of effective therapies for metastatic cancers, the granting of a third Orphan Drug Designation by the FDA at this time is both encouraging and confirmatory. Orphan Drug Designation provides important economic incentives and powerful market protections that encourage the development of innovative products in the cancer field. U.S. Orphan Drug Designation provides seven years of market exclusivity for Rexin-G, a reduction in fees and taxes, and additional regulatory support for ongoing R&D initiatives.

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 proprietary targeted delivery systems. To learn more about our pipeline of biotechnologies and products that are currently available for licensing and clinical development, please visit our website, www.epeiusbiotech.com.

For more information about Rexin-G, on-going clinical trials in the USA and abroad, please contact Dr. Erlinda M. Gordon at egordon@epeiusbiotech.com.

Copyright © 2008 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Epeius Biotechnologies Corporation, biopharmaceutical company

Epeius Biotechnologies Leads with Keynote Address on the Advent of Pathotropic Medicine for Cancer at the Global Pharma RandD Summit Conference in Boston

Thu, 18 Oct 2007 22:13:00 GMT

SAN MARINO, Calif. and BOSTON, Mass. - Oct. 18 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced that Dr. Frederick L. Hall, President and CEO of Epeius Biotechnologies Inc., has accepted an invitation to give the lead keynote address on "The Advent of Pathotropic Medicine for Cancer" at the Global Pharma R&D Summit 2007 to be held in Boston MA. On October 22, 2007 at 8:00 a.m., Dr. Hall will present the scientific principles, the clinical validation, and global development status of the company's innovative pathotropic (disease-seeking)-targeting technology embodied in its lead product, Rexin-G, the first pathotropically targeted genetic medicine developed for the treatment of advanced-stage and metastatic cancer.

The Global Pharma R&D Summit 2007 (www.globalpharmasummit.com), which will be held at the Boston Marriott Hotel, Newton MA 02466 USA, on October 22-23, 2007, showcases cutting-edge biotechnology and pharmaceutical companies that are developing superior technologies and products in healthcare and healthcare related areas, and offers a forum to meet with suppliers, service providers, opinion leaders, and representatives from other leading pharmaceutical and biotechnology companies worldwide. The Keynote Address provides an opportunity for Epeius to update the industry in regard to its recent clinical developments and global partnering initiatives to expedite the international development of Rexin-G, which is currently in clinical trials in Europe, Japan, and ASEAN member countries, as well as the United States.

The focus on Epeius Biotechnologies during National Breast Cancer Awareness Month, is apropos-for the company has just opened an Advanced Phase I/II trial for chemo-resistant breast cancer in San Marino and Santa Monica California. Rexin-G, has received Orphan Drug Status from the FDA based on unprecedented demonstrations of single-agent efficacy in treating pancreatic cancer. Subsequently, the company has gained federal support and private agency support to continue their landmark clinical trials in the United States using intravenous Rexin-G for breast cancer that afflicts one of 4 women and sarcoma that afflicts teenagers and young adults. These Phase I/II clinical trials with adaptive trial designs will facilitate the development of Rexin-G for breast cancer, sarcoma and pancreatic cancer in the United States.

In addition to leading the advancement of bioscience and medicine from "the bench to the bedside" in a manner that is unprecedented in modern times, Dr. Hall and the senior management team of Epeius Biotechnologies continues to raise the bar for the biopharmaceutical industry in terms of corporate productivity, R&D efficiency, and significant drug development. Having (i) gained exclusive licensing rights for all of the tumor targeting and molecular-genetic technologies embodied in Rexin-G, (ii) conducted international clinical trials that validated the lead product, (iii) advanced the yield of biopharmaceutical GMP through a series of major technological innovations, (iv) attained both Orphan Drug Status and Expanded Access Designation through various regulatory authorities, (v) generated the company's first million dollars in revenues through product sales, and (vi) initiated a bold corporate outreach program that facilitated the development of strategic alliances and corporate partnering, Dr. Hall's invited Keynote Address at the Global Pharma R&D Summit will be a tough act to follow.

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 proprietary targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer therapeutic genes, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, to advanced biopharmaceutical manufacturing and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide. Rapid advances in clinical drug development provide Epeius with a unique opportunity for early revenues from the exportation and sale of its lead product to the Philippines and reciprocating Southeast Asian countries-thus demonstrating the high growth potential of a small biotechnology company while maintaining the lowered risk profile of a biopharmaceutical company with a high-value, late-stage product.

To learn more about Rexin-G and Epeius' pipeline of proprietary compounds currently available for partnership or clinical trials, please visit us at www.epeiusbiotech.com.

Copyright © 2007 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Epeius Biotechnologies Corporation, Global Pharma Summit Conference

California Biotechnology Company Takes Aim at Pancreatic Cancer With an Advanced Phase I/II Clinical Trial Using Rexin-G(TM), a Targeted Injectable Gene Delivery System

Tue, 10 Jul 2007 14:00:00 GMT

SAN MARINO, Calif. - July 10 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation announced today that an advanced Phase I/II clinical trial using intravenous Rexin-G(TM) for pancreatic cancer that is refractory to standard chemotherapy will open in the summer of 2007 in Los Angeles, California. Rexin-G is the world's first tumor-targeted injectable gene delivery system that is designed to seek out and destroy both primary tumors and metastatic cancers that have spread throughout the body.

Recently, the FDA granted Orphan Drug Status for Rexin-G for the treatment of pancreatic cancer while the Philippine BFAD granted Expanded Access Use of Rexin-G for the treatment of all chemo-resistant solid tumors.

According to Erlinda M. Gordon, M.D., Medical Director of Epeius, the upcoming clinical trial incorporates a Phase II component that will evaluate the efficacy of Rexin-G using an adaptive trial design. Each treatment cycle will be six weeks: four weeks of treatment and two weeks of rest. Unlike a standard Phase I protocol, eligible patients may have repeat cycles after the safety data and objective tumor response/s are recorded. Continued Rexin-G treatment will enable the targeted nanomedicine to catch up with tumor growth, halt disease progression, and reduce tumor burden with a new dosing paradigm (called "the Calculus of Parity") described by Gordon et al. (Int'l J Oncol, Vol. 29, pp. 1053-1064, 2006). The treatment strategy is to achieve tumor control as quickly as safely possible. The goal of the adaptive trial design is to confirm the overall safety of Rexin-G and to determine the optimal dosing regimen for Rexin-G that would document the significant clinical benefits required to support a Phase II registration protocol.

The clinical trial using Rexin-G for pancreatic cancer is the third of three advanced Phase I/II protocols that will be conducted by Sant P. Chawla, M.D., in the Epeius Clinical Research Unit in San Marino, CA, and in the Sarcoma Oncology Center in Santa Monica, CA. Two other trials for sarcoma and breast cancer have been approved by the FDA. Dr. Sant P. Chawla, who trained at the University of Texas M.D. Anderson Cancer Center, is a renowned expert in sarcoma, and has agreed to serve as principal investigator for all three clinical trials.

For further information concerning these clinical trials, please contact Dr. Gordon at egordon@epeiusbiotech.com.

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 proprietary targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer therapeutic genes, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, advanced biopharmaceutical manufacturing and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide.

Rapid advances in clinical drug development provide Epeius with a unique opportunity for early revenues from the exportation and sale of its lead product to the Philippines and reciprocating Southeast Asian countries-thus demonstrating the high growth potential of a small biotechnology company while maintaining the lowered risk profile of a biopharmaceutical company with a high-value, late-stage product.

To learn more about Rexin-G and Epeius' pipeline of proprietary compounds currently available for partnership or clinical trials, please visit us at www.epeiusbiotech.com.

Copyright © 2007 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Epeius Biotechnologies, cancer research

Osmetech Licenses Self-Assembling Monolayer (SAM) Technology to Minerva Biotechnologies Corporation

Mon, 18 Jun 2007 23:36:00 GMT

PASADENA, Calif. - June 18 (SEND2PRESS NEWSWIRE) -- Osmetech plc (LSE, AIM; OMH) today announced that it has granted a non-exclusive research license to Waltham, Massachusetts, US-based Minerva Biotechnologies Corporation ("Minerva") for use of Osmetech's self-assembling monolayer (SAM) technology in conjunction with Minerva's proprietary nanoparticle technology.

Osmetech, a fast developing, international molecular diagnostics business with operations in Boston and Pasadena, USA serves the high growth, near patient testing market and holds exclusive rights to the technology, which it exclusively licensed from Harvard University in 1997, and for which Minerva's founder and Chief Scientific Officer, Cynthia Bamdad, Ph.D., was the lead inventor. Financial details were not disclosed.

SAM technology is finding increasing merit in array and sensor technologies, particularly in electrochemical biosensing, where it is used to minimize background signal, provide for uniform functionalized attachment of molecules to surfaces and reduce nonspecific aggregation events. Minerva plans to use SAMs in tandem with its proprietary nanoparticle technology for signal enhancement, drug design, drug screening, and functional proteomics. Osmetech, by contrast, uses the technology in conjunction with nucleic acid analyte diagnostics. Late last year Osmetech licensed the same technology to Illinois-based Ohmx Corporation for use in non-nucleic acid analyte detection schemes, and is currently in dialog with a number of other companies that have also expressed interest, according to Edward Kreusser, Osmetech's VP of Intellectual Property and Legal Affairs.

"SAM use is by no means limited to electrochemical detection and is just one complementary piece of a much broader intellectual property position held in that field by Osmetech. In addition to the Harvard SAM IP, Osmetech also holds exclusive rights to very valuable biosensing patents owned by California Institute of Technology (Caltech), University of North Carolina, CMS and Concordia University, as well as a host of nonexclusive patent rights to a variety of related IP," says Kreusser.

James White, CEO of Osmetech said, "When Osmetech acquired Clinical Micro Sensors, Inc. (CMS) from Motorola, it came with a patent portfolio that had over $25 million spent on it and has over 145 granted patents worldwide with many more pending. This is another good example of our ability to maximize our economic return by actively out-licensing our significant intellectual property portfolio into non-diagnostic areas. We look forward to announcing other partnerships in the near future."

About Osmetech
Osmetech plc (www.osmetech.com) is an AIM-listed public company on the London Stock Exchange. The company is a fast developing, international molecular diagnostics business with operations in Boston and Pasadena in the US, serving the high growth, near patient testing market targeting small to medium sized hospitals. Osmetech has launched eSensor(R), an FDA cleared electrochemistry-based array system, for cystic fibrosis carrier detection and plan to launch a number of pharmacogenomic assays utilizing the same proprietary technology.

About Minerva Biotechnologies Corporation
Minerva Biotechnologies Corp. has developed a nanoparticle product line called Nano Vision. The first product is Nano Specs which are user-friendly nanoparticles that are functionalized to instantly capture and present any affinity tagged molecule. Minerva has proprietary nanoparticle applications in drug screening, disease diagnosis, and high throughput proteomics.

Copyright © 2007 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Osmetech plc, Minerva Biotechnologies Corp

Mark Whitacre, Ph.D. Joins Management Team at Cypress Systems, Inc.

Wed, 13 Jun 2007 14:15:00 GMT

Company Launches Related Website at MarkWhitacre.com

FRESNO, Calif. - June 13 (SEND2PRESS NEWSWIRE) -- Cypress Systems, Inc, a Fresno CA based biotechnology company, announced that it has hired Mark Whitacre, Ph.D. Dr. Whitacre joined the executive management team effective January 1, 2007 as COO & President, Technology and Business Development, following the opening of a new office in Pensacola, Florida in December, 2006.

The company's CEO & President, Paul A. Willis, states that "By hiring Dr. Whitacre, we have taken a significant step in the effort to expand the selenium based cancer prevention research, develop next generation products, and seek new technologies to expand our existing product offerings. Dr. Whitacre's research and top management business experience fully aligns with the future direction of the company and the continued expansion into fermentation for biotechnology and life science applications."

*(Photo Caption: Mark Whitacre Ph.D.)

In an effort to provide greater detail related to Mark Whitacre's extensive education, research accomplishments, management experience, professional career, and his current work with Cypress, the company has recently launched a new website at www.markwhitacre.com.

Mark E. Whitacre's extensive education includes B.S. and Master's degrees from Ohio State University and a Ph.D. in Nutritional Biochemistry from Cornell University where Mark's Ph.D. thesis adviser was a renowned selenium researcher, Dr. G.F. Combs, Jr. Mark continued his studies after Cornell earning multiple advanced degrees which are listed on the new website.

As stated by Paul A. Willis, "Dr. Whitacre's earlier research at Cornell University related to the biochemical role of selenium in the prevention of diseases combined with his extensive management experience in the area of biotechnology and microbial fermentation, makes him an outstanding addition to our management team and strengthens our efforts to grow the company's technology and business base. The new website provides additional information specifically related to Mark's background and it also builds onto our existing website at cypsystems.com."

The company's flagship branded ingredient, SelenoExcell High Selenium Yeast, has been selected as the sole intervention agent in a series of cancer prevention and health related trials. SelenoExcell is supported by a Clinical Trial Agreement (CTA) with the Cancer Prevention Division of the National Cancer Institute (NCI). Recently, SelenoExcell received independent GRAS (Generally Recognized As Safe) evaluation to be used in several food categories. The evaluation was based on scientific procedures and the safety assessment criteria established by the U.S. Food and Drug Administration (FDA). The company believes that Dr. Whitacre will bring extensive science and management experience to these key human nutrition research and market areas, as well as it's complete line of yeast-based animal nutrition products.

Dr. Whitacre is best known publicly for his role as the whistleblower in the price fixing case involving the Archer Daniels Midland (ADM) Company. Mark was a former President of the ADM BioProducts Division. The ADM case is well documented in hundreds of articles and was the subject of two books. One of the authors, James B. Lieber, a lawyer who wrote the book titled, "Rats in the Grain," has been very active - along with Paul Willis and Dean Paisley (former FBI Supervisor over the ADM case) - in a serious attempt to obtain Presidential Clemency or a Pardon for Dr. Whitacre. Furthermore, the numerous supporters of Mark Whitacre are still very active today with this endeavor.

"We are fully aware of the details of this case and Dr. Whitacre's specific involvement. We consider ourselves to be among a growing list of supporters, which include current and former FBI agents, former U.S. and Canadian prosecutors, several prominent law firms, and numerous other professionals. We desire, like others, to move forward from this point and build a positive contribution in several health-related research areas. Mark Whitacre will be a valued asset in that ongoing effort," said Paul A. Willis.

More information: www.cypsystems.com.

Copyright © 2007 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, cancer prevention research, Cypress Systems Inc

Epeius Biotechnologies to Present the Advent of Tumor Targeting Technology and the Clinical Development of its Lead Anti-Cancer Agent, Rexin-G(TM), at Upcoming Bioventure, Nanotechnology and Nanomedicine Conferences

Tue, 15 May 2007 14:00:00 GMT

SAN MARINO, Calif. - May 15 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced that Dr. Frederick L. Hall, President and CEO of Epeius Biotechnologies, has accepted an invitation to speak during the 9th annual C21 BioVentures Conference. On May 23 at 11:15 am, Dr. Hall will present the scientific principles, clinical validation, and global development status of the company's innovative tumor-targeting technology embodied in its lead product, Rexin-G, the first targeted genetic medicine developed to treat metastatic cancer.

Dr. Hall has also accepted an invitation to provide a practical overview of the company's proprietary targeting technology and the application of this highly advanced biotechnology in the development of new products for cancer therapy at the upcoming 2nd International Congress of Nanobiotechnology & Nanomedicine, NanoBio2007.

The C21 BioVentures Conference, which will be held in Monterey Bay, Calif. May 22-24, 2007, showcases cutting-edge private biotechnology and pharmaceutical companies that are developing superior technologies and products in healthcare and healthcare related areas, and offers them a forum to reach top venture capitalists and key decision makers from leading pharmaceutical and biotechnology companies worldwide. The pronounced visibility that C21 offers will provide an opportunity for Epeius to discuss global partnering initiatives and the company's plans to expedite the international development of Rexin-G.

The NanoBio2007 Conference will be held in San Francisco, Calif. June 18- 21, 2007 and will highlight innovative scientific R & D in nanotechnology, as well as business and investment opportunities in the emerging Nanomedicine industry. Epeius, with its best-of-breed targeting technology, and its lead product incontrovertibly validated in the clinic, is well positioned to leverage the positive attributes of both genetic medicine and applied nanotechnology while also offering a novel, safe, and effective medical technology platform with which to engineer a wide variety of anti-cancer agents, targeted cancer vaccines, and cancer diagnostic/imaging products.

The powerful anti-cancer agent Rexin-G, the first tumor targeted genetic medicine developed by Epeius Biotechnologies, has received Orphan Drug Status from the FDA based on unprecedented demonstrations of single-agent efficacy in treating pancreatic cancer.

Subsequently, the company has gained federal support to continue their landmark clinical trials in the US using intravenous infusions of Rexin-G for treating this intractable metastatic cancer. Further, Rexin-G has gained Expanded Access status in the Philippines for treating all solid tumors that are resistant to chemotherapy - other focus areas include metastatic breast cancer, bone and soft tissue sacoma, lung cancer, colon cancer, skin cancer, and malignant melanoma.

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 proprietary targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer therapeutic genes, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, to advanced biopharmaceutical manufacturing and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide.

Rapid advances in clinical drug development provide Epeius with a unique opportunity for early revenues from the exportation and sale of its lead product to the Philippines and reciprocating Southeast Asian countries-thus demonstrating the high growth potential of a small biotechnology company while maintaining the lowered risk profile of a biopharmaceutical company with a high-value, late-stage product.

To learn more about Rexin-G and Epeius' pipeline of proprietary compounds currently available for partnership or clinical trials, please visit us at epeiusbiotech.com.

Copyright © 2007 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Nanomedicine Conference, Epeius Biotechnologies RexinG

Rexin-G(TM), The World's First Tumor-Targeted Gene Therapy Vector, Stymies Metastatic Cancer

Mon, 06 Nov 2006 13:36:00 GMT

SAN MARINO, Calif. and MANILA, Philippines - Nov. 6 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies today announced the publication of clinical data from studies conducted at the University of the Philippines, Asian Hospital and Medical Center, Makati Medical Center, Manila, Philippines and Lutheran Medical Center, New York, USA, revealing the safety and single agent efficacy of Rexin-G(TM) for the treatment of a broad spectrum of chemotherapy-resistant cancers.

The milestone article, appearing in this month's issue of the International Journal of Oncology, reports on 3 clinical studies involving patients with various chemo-resistant tumor types who received Rexin-G in Phase I/II and expanded access protocols. In the first study, progressive tumor reduction and/or necrosis were noted in 83% (n = 6) of patients with advanced or metastatic pancreatic cancer, while in the second study, an objective tumor response was observed in 64% (n = 11) of patients with metastatic breast, colon, uterine, muscle and vocal cord cancer, as well as malignant melanoma.

Median survival after Rexin-G treatment was 10 months in the first study, and greater than six months in the second study. In the third study, wherein an innovative mathematically calculated optimal dose of Rexin-G (designated "Calculus of Parity") was given to three patients, tumor reduction and/or necrosis were achieved in 100% of patients. Based on these studies, the following conclusions were reached: (i) the functionality of the targeted gene delivery system is profound, (ii) the genetic construct exhibits broad spectrum activity in many resistant tumor types, and (iii) the targeted genetic medicine is exceptionally safe.

The lack of systemic toxicity, taken together with the reduction of tumor burden and the enhanced quality-of-life experienced by patients receiving Rexin-G infusions, constitute meaningful clinical benefits that underscore the need for the expedited development of Rexin-G for pancreatic cancer and, potentially, for all solid tumors.

In a statement to the press, Dr. Frederick L. Hall, President and CEO of Epeius, stated "Whereas logistics had previously stymied the delivery of genetic medicine to target lesions within the human body, intravenous infusions of Rexin-G has stymied intractable cancers without collateral damage to normal organs."

The results, compiled in these pioneering studies, had convinced the US FDA to grant Rexin-G orphan drug status for pancreatic cancer, and subsequently, to provide federal support to continue clinical trials using Rexin-G in the United States. Further, based on these studies, the Philippine Bureau of Food and Drugs recently granted Rexin-G accelerated marketing approval for the treatment of all chemotherapy-resistant tumor types.

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 proprietary targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer-gene therapy, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, to advanced GMP and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide.

To learn more about Rexin-G and Epeius' pipeline of proprietary therapeutics currently available for partnership, please visit us at www.epeiusbiotech.com.

Copyright © 2006 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Epeius Biotechnologies Corporation, Targeted Gene Therapy Vector

Epeius Biotechnologies Affirms Leadership Role in The Development of Genetic Medicine

Wed, 11 Oct 2006 16:18:00 GMT

Accepts Invitations to Speak At Two Prestigious Industry Conferences

SAN MARINO, Calif. - Oct. 11, 2006 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced that Dr. Frederick Hall, President and CEO of Epeius Biotechnologies, has accepted an invitation to speak at the upcoming Global Pharmaceutical Research & Development Summit held on Oct. 24 at 4:10 p.m. (PT) in Anaheim, Calif. Dr. Hall will present the current status of global development and the broad pharmaceutical indications for the company's innovative targeting technology platform that has enabled Epeius to develop Rexin-G(TM), the world's first tumor-targeted gene therapy system that actually works in humans. Rexin-G was recently approved for the treatment of all solid tumors in the Philippines and is currently in clinical trials at several medical centers in the U.S., Manila, and Japan.

In addition, Dr. Erlinda Maria Gordon, Vice President of Operations and Medical Affairs, will be chairing a session on genetic medicine at the upcoming Oncology Leaders Forum on Oct. 31 at 12:50 p.m. (PT) at the Torrey Pines Hilton Hotel, in La Jolla Calif. Dr. Gordon's session will discuss the impact of targeted gene delivery systems, specifically Rexin-G, on the treatment of chemo-resistant cancer types, which comprise about 80 percent of the cancer population.

The Global Pharmaceutical Research & Development Summit, which will be held on Oct. 23-25, is attended by the world's leading drug research and development professionals and features invited speakers from cutting edge biotechnology companies, top executives from the FDA and the World Health Organization (WHO), leading academic researchers and decision makers in large pharmaceutical companies. The Oncology Leaders Forum, held on Oct. 30-Nov. 1, is an annual meeting for the industry leaders driving the development, approval, and launch of novel cancer therapies of all classes. Both conferences offer the opportunity for industry leaders to discuss with Epeius executives potential partnering opportunities for the expedited development of their lead product, Rexin-G, and for the development of new products in the fields of oncology and cardiovascular disease.

Rexin-G has received Orphan Drug Status based on unprecedented demonstrations of single-agent efficacy in pancreatic cancer. Subsequently, the company gained federal support to continue their landmark clinical trials using intravenous infusions of Rexin-G for treating metastatic cancer. Further, Rexin-G has gained accelerated marketing approval in the Philippines for treating all solid tumors that are resistant to chemotherapy.

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 proprietary targeted delivery systems. Credited with innovations ranging from oncogene discovery, to designer-gene therapy, to pathotropic (disease-seeking) targeting, to high-performance vector engineering, to advanced GMP and bioprocess development, Epeius Biotechnologies is well positioned to "launch" its enabling platform technologies for the benefit of cancer patients worldwide.

Rapid advances in clinical drug development provide Epeius with a unique opportunity for early revenues from the exportation and sale of its lead product to the Philippines and reciprocating Southeast Asian countries-thus demonstrating the high growth potential of a small biotechnology company while maintaining the lowered risk profile of a biopharmaceutical company with a high-value, late-stage product.

To learn more about Rexin-G(TM) and Epeius' pipeline of proprietary compounds currently available for partnership, please visit us at www.epeiusbiotech.com.

Copyright © 2006 Send2Press® Newswire, a unit of Neotrope®
TAGS: Send2Press Newswire, Epeius Biotechnologies, biopharmaceutical company

Reaction Biology Corp. Awarded NIH SBIR Grant for Kinase Radioisotope Microarray Screening Development

Tue, 20 Jun 2006 15:15:00 GMT

MALVERN, PA - June 20 (SEND2PRESS NEWSWIRE) -- Reaction Biology Corporation ("RBC") today announced that it has been awarded an SBIR grant from the National Cancer Institute to create a new kinase profiling and high throughput screening method using radioisotopes and microarrays. The $940,000 grant will be used to migrate the current well-plate radioisotope methods onto RBC's DiscoveryDot(TM) nanoliter screening platform.

Protein kinase dysfunction is a key factor in cancer, inflammation and diabetes. Screening and profiling kinase inhibitors has been a major research and development effort in the pharmaceutical industry. While screening kinase activity with radioisotope detection is considered by many in the drug-discovery industry to be the "gold standard" of kinase assays, use of the format is limited by expense and the difficulty of radioactive disposal.

The DiscoveryDot(TM) platform uses only a fraction of the reagents compared to well plate methods. "Due to our nano-scale format, the amount of radioisotope used in the process should be minimal," said RBC Chief Technology Officer Haiching Ma, Ph.D. "This should lead to far fewer disposal and handling problems, and reduced cost overall."

About Reaction Biology Corporation

Reaction Biology, based in Malvern, Pa., provides high throughput screening services to the biotechnology and pharmaceutical industries. The company uses a patent-pending combination of technologies to perform screening at the nanoliter scale, while preserving quality, speed and simplicity. Combining genomics microarray printing technology and picoliter aerosol deposition, RBC has commercialized a novel technology that drives HTS to new levels of simplicity and efficiency.

More information: http://www.reactionbiology.com

Key Organics Ltd and Reaction Biology Corporation Announce New Library Screening Format

Thu, 01 Jun 2006 05:12:00 GMT

CORNWALL, UK and MALVERN, PA - June 1 (SEND2PRESS NEWSWIRE) -- Key Organics Ltd ("Key") and Reaction Biology Corporation ("RBC") today announced that they have teamed up to provide a new library screening format to customers. Beginning this summer, the entire Key Bionet library of 37,500 diverse drug-like compounds will be offered for "rental" screening on RBC's DiscoveryDot(TM) platform. For the first time, customers will be able to screen the Key library without having to purchase it outright.

"While we have many large pharma clients who wish to purchase compounds directly, we see an unmet need in smaller pharma and biotech companies that want to screen one or more of their targets without investing in a library purchase," said Colin Piper, Business Development Manager for Key. "RBC's platform gave us an economical way to reach these potential customers. Now researchers who do not have a budget for library purchases can still afford library screening."

The Key library will be screened locally at RBC's lab facilities in Malvern PA. RBC will reformat the library to its microarray-based platform. "Our nanoliter-scale screening process means that we can we offer lower costs to customers, while our partnership with Key provides a clear path to additional chemistry expansion," said Tom Festa, National Sales Manager for RBC.

About Reaction Biology Corporation

Reaction Biology, based in Malvern, Pa., provides high throughput screening services to the biotechnology and pharmaceutical industries. The company uses a patent-pending combination of technologies to perform screening at the nanoliter scale, while preserving quality, speed and simplicity.

Combining genomics microarray printing technology and picoliter aerosol deposition, RBC has commercialized a novel technology that drives HTS to new levels of simplicity and efficiency. http://www.reactionbiology.com

About Key Organics Ltd.

Key Organics Limited was formed in 1986 to supply schemes of novel, benzenoid and heterocyclic chemistry to its customers under confidentially agreements. During Key's growth over the last 20 years, custom and contract synthesis and lead optimisation programmes for clients worldwide have become an increasingly important part of its business.

The Company is based at its own well-equipped multi-lab site in Camelford, Cornwall, UK. Key Organics employs Graduate and Ph.D. chemists, including medicinal chemists, with experience in a wide range of chemical techniques and technologies. Key Organics is able to supply mg to kg quantities of compounds to a high specification. http://www.keyorganics.ltd.uk

Epeius Biotechnologies Establishes Corporate Headquarters in San Marino, California - Facilities Include a Clinical Research Unit Dedicated to Evaluating New Genetic Medicine for Cancer

Tue, 04 Apr 2006 18:08:00 GMT

SAN MARINO, CA - April 4 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation (www.epeiusbiotech.com) announced today the establishment of its main corporate headquarters in San Marino, California. The specialty pharmaceutical company has been granted Orphan Drug Status by the FDA for its lead product Rexin-G(TM), an innovative anti-cancer agent that seeks out and destroys metastatic disease. Rexin-G(TM) has been tested in a wide variety of cancer types, including pancreatic cancer, breast cancer, colon cancer, uterine cancer, laryngeal cancer, smooth muscle cancer (leiomyosarcoma) and skin cancer (malignant melanoma).

Rexin-G(TM) is currently in clinical trials for metastatic pancreatic cancer at Mayo Clinic, Rochester, Minnesota, USA and is available for all solid tumors through an expanded access program in Manila, Philippines. The new headquarters in San Marino is located on the prestigious Huntington Drive and will integrate corporate offices, medical laboratories, and a Clinical Research Unit in appealing garden setting.

*(Photo Caption: Artist rendering of proposed renovated San Marino headquarters.)

Founded in the year 2000 by an inspired physician and an intrepid biophysicist at the University of Southern California, Epeius Biotechnologies consolidates a decade of biomedical research that began with gene discovery at Childrens Hospital Los Angeles, was translated into medical delivery at the USC Keck School of Medicine, progressed to clinical development at the USC Norris Comprehensive Cancer Center, and conducted landmark clinical trials as a freestanding biopharmaceutical company.

In a statement to the press, Dr. Erlinda Maria Gordon, M.D., founder and Chairman of the Board stated: "In the years to come, we hope and expect that the scientific and clinical accomplishments of Epeius Biotechnologies Corporation will become a source of pride and joy for the entire San Marino community."

For more information about Epeius Biotechnologies Corporation visit: http://www.epeiusbiotech.com

Reaction Biology Corp. Awarded Phase II SBIR Grant for Drug Discovery

Tue, 09 Aug 2005 10:56:00 GMT

MALVERN, PA - August 9 (SEND2PRESS NEWSWIRE) -- Reaction Biology Corporation ("RBC") today announced that it has been awarded a Phase II SBIR grant from the National Institutes of Health to apply its new DiscoveryDot(TM) High Throughput Screening technology for drug discovery.

The $750,000 grant originates from the National Institute of Dental and Craniofacial Research and funds the use of RBC's DiscoveryDot(TM) microarray technology for high throughput screening of caspases and other proteases. The DiscoveryDot(TM) technology is capable of screening up to 6,600 individual reactions on a 1-by-3 inch glass slide. The one nanoliter reaction volume used by RBC represents one ten thousandth the volume of conventional screening systems, and can potentially save millions of dollars on large scale screening campaigns through reagent savings, process costs, and labor reduction.

Caspases play pivotal roles in regulating cell apoptosis and represent targets of significant interest in craniofacial medicine and other areas. RBC's ability to print large chemical compound libraries in hundreds of replicate copies for caspase and protease screening can accelerate early stage lead identification at a fraction of the cost of conventional technology.

About Reaction Biology Corporation

Reaction Biology, based in Malvern, Pa., provides high throughput screening services to the biotechnology and pharmaceutical industries. The company uses a patent-pending combination of technologies to perform screening at the nanoliter scale, while preserving quality, speed and simplicity. Combining genomics microarray printing technology and picoliter aerosol deposition, RBC has commercialized a novel technology that drives HTS to new levels of simplicity and efficiency.

More information: www.reactionbiology.com

Clinical Trial For Pancreatic Cancer Opens at Mayo Clinic Using Tumor-Targeted Gene Therapy Vector

Fri, 15 Jul 2005 12:03:00 GMT

LOS ANGELES, Calif. - July 15 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation (www.epeiusbiotech.com), announced today that a Phase I clinical trial has opened at Mayo Clinic Cancer Center, Rochester, Minnesota to test the safety of Rexin-G(TM), the first tumor-targeted gene therapy vector to gain Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. The clinical protocol has passed the rigorous reviews of the FDA, the NIH/Recombinant Advisory Committee, and the Institutional Review Board of Mayo Clinic.

A maximum of 24 eligible patients will be entered into the study. Interested persons may call Mayo Clinic Cancer Center at Tel. No.: 507-538-7623 to determine eligibility and potential participation in the study.

ABOUT THE REXIN-G CLINICAL TRIAL:
This is a dose-seeking study that will test the safety of increasing doses of Rexin-G(TM), given intravenously, in patients with advanced or metastatic pancreatic cancer who have failed standard chemotherapy. Rexin-G(TM) is a tumor-targeted gene therapy vector that contains a "killer" gene that blocks the action of the human cyclin G1 gene. Cyclin G1 is a cell cycle control element that plays an important role in cancer cell growth. When injected into a vein, the Rexin-G(TM) vector seeks out and accumulates in cancerous tumors, therefore, increasing the concentration of the drug in the cancerous tumors and not in normal neighboring organs.

ABOUT EPEIUS:
Epeius Biotechnologies Corporation is a privately held biopharmaceutical company that was formed to develop and commercialize the first truly effective Targeted Gene Delivery System (TDS) that can be injected directly into a vein to deliver genetic medicine preferentially to cancerous tumors that have spread throughout the body (metastatic cancer).

Recently, Epeius was granted the approval to provide "Expanded Access to Rexin-G(TM)" by the Philippine Bureau of Food and Drugs for pancreatic and breast cancer. This means that Rexin-G(TM) is now available on a limited commercial basis for the treatment of pancreatic and breast cancer in Manila, Philippines.

More information: www.epeiusbiotech.com.

Rexin-G is a trademark of Epeius Biotechnologies Corporation

Reaction Biology Corporation Awarded NIH Kinase Grant

Tue, 21 Jun 2005 10:21:00 GMT

MALVERN, PA - June 21 (SEND2PRESS NEWSWIRE) -- Reaction Biology Corporation ("RBC" - www.reactionbiology.com) today announced that it has been awarded a Phase I SBIR grant from the National Institutes of Health to develop its new microarray kinase screening technology for testing compounds in nanoliter reactions.

The grant funds the use of RBC's DiscoveryDot(tm) microarray technology for high throughput screening of kinases. The DiscoveryDot(tm) technology is capable of screening up to 6600 individual reactions on a 1-by-3 inch glass slide. Its one nanoliter reaction volume is one ten thousandth the volume of conventional screening systems, and can potentially save millions of dollars on large scale screening campaigns through reagent savings, labor reduction, and multiple compound library printing.

Protein kinases play pivotal roles in signal transduction and represent one of the most studied targets in the pharmaceutical and biotechnology industry, particularly with respect to cancer or inflammation therapy. The ability to print large chemical libraries in hundreds of replicate sets for kinase and phosphatase screening can drive chemical-proteomic research, environmental toxicology, hit discovery and prioritization, and lead selection. RBC plans to expand its assay range across the human kinome using the DiscoveryDot(tm) assay.

About Reaction Biology Corporation

Reaction Biology, based in Malvern, Pa., provides high throughput screening services to the biotechnology and pharmaceutical industry. The company uses a patent-pending combination of technologies to perform screening at the nanoliter scale, while preserving quality, speed and simplicity. Combining genomics microarray printing technology and picoliter aerosol deposition, RBC has commercialized a novel technology that drives HTS to new levels of simplicity and efficiency.

More information: www.reactionbiology.com

Phase I Clinical Trial for Advanced Colon and Pancreatic Cancer Opens in New York Using Rexin-G, the World's First Tumor-Targeted Gene Delivery Vector

Tue, 05 Apr 2005 12:52:00 GMT

LOS ANGELES, Calif. -- (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation (www.epeiusbiotech.com) announced today that a Phase I clinical trial has opened in New York to test the safety and efficacy of Rexin-G, the leading tumor-targeted gene delivery system (vector) developed for the treatment of metastatic colon and pancreatic cancer.

In 2003, Rexin-G gained FDA approval as an Orphan Drug based on clinical demonstrations of the medical utility of Rexin-G as an effective treatment for pancreatic cancer.

Six out of six initial patients with advanced pancreatic cancer responded favorably to Rexin-G, as evidenced by significant shrinkage and/or disappearance of metastatic tumor nodules, or stabilization of disease, relief from pain, weight gain and extension of over-all survival time, without experiencing the side effects generally associated with standard chemotherapy. Clinical trials of Rexin-G have now been expanded to include patients with colorectal cancer that has spread to the liver.

Epeius Biotechnologies Corporation recently secured exclusive licensing rights to its Pathotropic (disease-seeking) targeting platform, including the FDA-approved Targeted Delivery System (TDS) that enables its lead product, Rexin-G, to seek and destroy metastatic tumors. Following the success of "compassionate use" clinical trials using Rexin-G for metastatic pancreatic cancer, Epeius Biotechnologies has completed the transition from an academic start-up to a specialty pharmaceutical company, and has gained the financial support needed to expand the scope of its landmark clinical trials in the United States.

In a statement to the press, Dr. Frederick Hall, President and CEO of Epeius said that, "We are now in an excellent position to complete our mission: to develop our business plan in an exemplary manner, and to commercialize our high-value lead product for the benefit of cancer patients worldwide."

About Epeius

Epeius Biotechnologies Corporation is a privately held biopharmaceutical company that was formed to develop and commercialize the first truly effective Targeted Delivery System (TDS) that can be injected directly into a vein to deliver genetic medicine preferentially to cancerous tumors that have spread throughout the body (metastatic cancer), without eliciting systemic side effects or organ damage.

More information: www.epeiusbiotech.com.