Rexin-G Controls Tumor Growth And Improves Survival In Chemotherapy-Resistant Sarcoma And Osteosarcoma: Phase I/II And Phase II Studies, ASCO 2009
19 May 2009
Epeius Biotechnologies announced the results of two related studies using Rexin-G, a tumor-targeted anti-cancer agent designed to seek-out and destroy metastatic cancers that have spread throughout the body. While Rexin-G is currently approved for the treatment of all solid tumors in the Republic of the Philippines, Epeius Biotech is conducting a series of advanced Phase I/II studies and a Phase II confirmatory trial in the U.S. The Phase I/II study evaluating the safety and efficacy of Rexin-G in chemotherapy-resistant metastatic bone and soft tissue sarcomas (ASCO Annual Meeting 2009, #10513) demonstrated that Rexin-G was well-tolerated with no dose-limiting toxicity. Moreover, Rexin-G exhibited dose-dependent efficacy in terms of tumor control rates, progression-free survival, and overall survival, thus validating both the efficiency of the tumor-targeting technology and the pharmacological mechanisms of action.
The efficacy and safety of Rexin-G was further confirmed in a Phase II study for chemotherapy-resistant osteosarcoma. Again, in the absence of dose-limiting toxicity, Rexin-G was demonstrated to control tumor growth, prolong progression-free survival, and improve overall survival in osteosarcoma patients who have failed known therapies. It is important to note that these outstanding results, were achieved when Rexin-G was administered as monotherapy-unlike many other so-called targeted biologics where one or more toxic agents are used in combination in order to achieve even marginal results. Based on a critical analysis of its performance in the clinic, the U.S. FDA recently granted Rexin-G Orphan Drug Status for both soft tissue sarcoma and osteosarcoma. The results of these studies will be presented by Dr. Sant P. Chawla, Sarcoma Oncology Center, Santa Monica, CA, and discussed by Dr. Katherine Janeway, Dana-Farber Cancer Institute, Boston, MA on Saturday, May 30, 2009 at 5:00 p.m. EST/EDT.
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 high-performance gene delivery systems that are embodied in Rexin-G and Reximmune-C, a tumor-targeted cancer vaccine.
Source: Epeius Biotechnologies Article URL:
http://www.medicalnewstoday.com/articles/150482.php
Main News Category: Bones / Orthopaedics
Also Appears In: Cancer / Oncology, Pharma Industry / Biotech Industry, Clinical Trials / Drug Trials,
Epeius Biotechnologies' Rexin-G Receives FDA Fast Track Designation for the Treatment of Pancreatic Cancer
Edited by Debra Tone
Wed, 17 Jun 2009, 06:00:17 EDT
SAN MARINO, Calif., June 17 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies (
www.epeiusbiotech.com) announced today that its lead product,
Rexin-G®, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for use as a second-line treatment for advanced or metastatic pancreatic cancer. The FDA Fast Track program, like Priority Review and Accelerated Approval, was implemented to facilitate the development and expedite the review of potentially important new drugs.
The Fast Track Product designation, in particular, is granted following a critical evaluation of the "seriousness" or life-threatening nature of the unmet medical need, namely pancreatic cancer, and the potential of Rexin-G and its progressive clinical development to address this unmet need.
"This is an excellent affirmation of all that we have worked for," says Dr. Erlinda Maria Gordon, Medical Director of Epeius Biotechnologies, "and an important validation of our medical mission." Indeed, Rexin-G is the
first in an entirely new class of targeted anti-cancer agents, with a sophistication that goes well beyond a simplistic antibody. Rexin-G is the flagship of tumor-targeted genetic medicine: "smart," "stealth," "selective" and "potent" nano-medicine that not only seeks out and accumulates in cancerous lesions that have spread throughout the body, but delivers a tumor-killing designer gene where it is needed most, selectively destroying tumor cells and their attendant blood supply, while sparing normal cells and healthy tissues.
As presented at the 2009 ASCO G.I. Symposium, "Rexin-G Shrinks Metastatic Tumors and Triples Survival Time in Chemotherapy-Resistant Pancreatic Cancer," documenting survival benefits, without toxicity, as monotherapy, when all else fails.
The FDA's timely decision to grant Rexin-G Fast Track Product Designation is not only validating in terms of the potential of this Investigational New Drug to meet an unmet medical need, but it reflects on the design and integrity of the clinical development program of Epeius Biotechnologies. "It took years of sustained effort, but our decision to firmly establish the overall safety of repeated infusions of Rexin-G in early-stage clinical trials, before we moved on to progressively higher doses, has served us well," said Dr. Gordon. "For it was in determining the actual needs of our patients, in concordance with ongoing FDA guidance, that eventually achieved the control of tumor growth and metastasis," she added.
Remarkably, the adaptive designs of the strategic dose-escalation studies not only served to confirm the overall safety of Rexin-G and the lack of either systemic or dose-limiting toxicity, but it served to establish the critical thresholds of bioactivity and the dose-response relationships in several intractable cancers, which confirms and reveals the physiological mechanisms-of-action. These quantitative aspects of applied pharmacology are of paramount importance in establishing the clinical utility of a major new class of biological agents. Moreover, the progressive and adaptive trial designs helped to create and refine the clinical protocols for future medical praxis.
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 high-performance gene delivery systems that are embodied in Rexin-G and Reximmune-C, a tumor-targeted cancer vaccine.
To learn more about ongoing clinical trials, please contact Dr. Erlinda M. Gordon at
egordon@epeiusbiotech.com, or visit:
www.epeiusbiotech.com.
Clinical Studies Validate Cancer Gene Delivery Platform: Landmark Publication Confirms Rexin-G Effectively Targets Metastatic Cancers
23 Jun 2009
Epeius Biotechnologies stuns the medical and scientific communities with a dramatic demonstration of single-agent efficacy with its lead product, Rexin-G, for metastatic cancer. The landmark article (accessible online as of June 16, 2009 in Molecular Therapy, the Official Journal of The American Society of Gene Therapy, documents the results of two related studies using Rexin-G, a tumor-targeted anti-cancer agent designed to seek-out and destroy metastatic cancers that have spread throughout the body, while sparing normal cells and healthy tissues and organs. Following the FDA's designation of Rexin-G as an Orphan Drug for the treatment of soft tissue sarcoma and osteosarcoma in 2008, the results of these two independent studies represent a major step toward gaining Accelerated Approval of Rexin-G for osteosarcoma in the United States.
"It took several years of painstaking safety studies, followed by gradual, progressive dose escalations, to the point where tumor control was consistently demonstrated, said Dr. Erlinda M. Gordon, Medical Director of Epeius Biotechnologies. Yet the progressive development strategy has finally paid off with real dividends: (1) By establishing the overall safety of the tumor-targeted gene delivery platform first and foremost, (2) By establishing critical pharmacological thresholds of bioactivity and dose-dependent efficacy for a new class of biological anti-cancer agents in otherwise intractable cancers, and (3) By validating the potential of Rexin-G to control metastatic cancer with single-agent efficacy, whereas other targeted therapies must be used in combination with one or more toxic agents in order to achieve even marginal results. The dividends for the cancer patient can now be measured in terms of overall survival, which is considered to be the gold standard in terms of evaluating efficacy.
About Epeius Biotechnologies
Rexin-G is commercially available for the treatment of all solid tumors in the Republic of the Philippines, and has "fast track status" as a treatment for pancreatic cancer in the United States. Epeius Biotechnologies Corporation is a privately held biopharmaceutical company dedicated to the advancement of genetic medicine with the development and commercialization of its high-performance gene delivery systems.
Sources: Epeius Biotech
Article URL:
http://www.medicalnewstoday.com/articles
/154894.php
Clinical Remissions in Three Otherwise Intractable Cancers Signal the Progress of Targeted Genetic Medicine
Mon, 12 Oct 2009, 13:49:28 EDT
Tumor-targeted REXIN-G Quells Metastatic Osteosarcoma, Prostate Cancer, and Pancreas Cancer as Stand-alone Therapy.
SAN MARINO, Calif., Oct. 12 (SEND2PRESS NEWSWIRE) -- Epeius Biotechnologies Corporation today announced more stunning results of its pioneering clinical studies of Rexin-G®, the world's first and, so far only, tumor-targeted genetic medicine to be validated in the clinic. Administered as stand-alone therapy in late-stage cases of chemotherapy-resistant cancer, Rexin-G has once again accomplished what standard cancer treatments and even much-touted biologics have failed to do: that is, to bring forth the benefits of remission in otherwise intractable metastatic cancers.
Three recent cases of Stage IV metastatic cancer, namely (i) osteosarcoma, (ii) prostate cancer, and (iii) pancreas cancer, demonstrated that Rexin-G treatments alone led to clinical remission of disease in each of these poor prognosis patients.
Even more remarkable, perhaps, are the profiles of the latter two patients, which signal the advent of Rexin-G as the vanguard of a new class of exceedingly precise, selective, and effective anti-cancer agents, and which typify a newfound societal acceptance and acknowledgement of the real-world promise and potential of this uniquely-targeted genetic medicine.
Remarkably,
a Catholic priest, who was previously bedridden and in withering pain, suffering from end-stage prostate cancer that had spread to his bones, received successive courses of Rexin-G, during which time the bone pain was relieved, the PSA tumor markers fell, the bone tumors stopped growing, and even the previously inoperable primary tumor disappeared on follow-up CT scans. As the priest's bones began to heal and strengthen, he arose from his bed and is currently saying daily Mass and delivering lectures in the seminary. What is even more remarkable is that this revered man of the cloth
was over ninety years old at the time of his treatment and remission.
This past week,
the latest good news comes from the trenches of Stage IVb pancreas cancer, where a complete clinical remission was documented in a patient undergoing Rexin-G treatment as stand-alone therapy in an ongoing U.S. Phase I/II clinical trial.
According to Erlinda Maria Gordon, M.D., Medical Director of Epeius Biotech, "It is gratifying to learn that more and more eminent medical oncologists around the world are recommending Rexin-G as 'Best Care' for patients with refractory metastatic disease, and even more gratifying to show how truly effective Rexin-G at these doses can be in eradicating such difficult cancers."
Indeed, as the
unprecedented single-agent efficacy of Rexin-G is incontrovertibly demonstrated in an increasing number of chemo-resistant cancers, the progressive steps of these intrepid pioneers may provide a rational basis of hope and expectation for many when standard therapy has failed. Rexin-G is approved for the treatment of all solid tumors in the Philippines, and
has been granted both Orphan Drug Status for pancreas cancer, osteosarcoma and soft tissue sarcoma, and Fast Track Designation for pancreas cancer by the U.S. FDA.
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 proprietary biotechnologies currently available for clinical development and/or new product development, please visit us at
www.epeiusbiotech.com.
NEWS SOURCE: Epeius Biotechnologies Corporation
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October 14, 2009
October 14, 2009 PDF Version
Advanced U.S. Clinical Trial Confirms Single-Agent Efficacy of Rexin-G in Metastatic Pancreas Cancer: All Endpoints Achieved.
Epeius Biotechnologies Reports Dose-Dependent Efficacy and Survival Benefits.
San Marino, Calif. - October 14, 2009 - Epeius Biotechnologies (
www.epeiusbiotech.com) confirms the first real breakthrough for pancreatic cancer seen in years; publishes a
landmark report of tumor-targeted Rexin-G as stand-alone therapy in chemotherapy-resistant pancreatic cancer. Following Phase I studies at the Mayo Clinic, which affirmed the general safety of Rexin-G, advanced U.S. Phase I/II studies were undertaken, which included a Phase II efficacy component and examined progressive dose escalations of Rexin-G, while monitoring objective tumor responses in a comprehensive manner. Employing these higher doses of Rexin-G led to improved tumor responses, as assessed by all available measures (RECIST, Intl. PET and CHOI criteria) and nearly tripled the expected survival time, all in a dose-dependent manner. Moreover, this U.S. study serves to establish a critical pharmacological threshold of bioactivity, for this otherwise intractable disease, by demonstrating an increase in overall survival time (measured as % surviving 12 months) from virtually nil using low doses to more than 28% of the patients using high doses surviving beyond one year.
By meeting all primary and secondary study endpoints of safety and efficacy, Epeius Biotechnologies’ Rexin-G has succeeded in an area of clinical oncology where many promising biologics have simply failed to deliver. By achieving both progression-free survival and overall survival benefits in pancreas cancer, while avoiding untoward systemic or dose-limiting toxicities, Rexin-G has raised the bar for the entire biopharmaceutical industry, as it inaugurates the emerging field of precision-targeted genetic medicine.
The outstanding results of this advanced U.S. clinical trial confirm the results of previous preclinical and clinical studies conducted in the Philippines (where Rexin-G is approved for all solid tumors), and demonstrate beyond contestation that Rexin-G, at these effective dose levels, exhibits profound anti-tumor activity when administered as a single therapeutic agent in otherwise intractable Stage IV pancreatic cancer. The success of these landmark studies is a tribute, not only to the clinical investigators who “held the course” and the “cause” of a better medicine as a high standard, but to the U.S. FDA who, by allowing across-the-board dose escalations in ongoing trials for sarcoma, breast, and pancreas cancer (once general safety was established), served to expedite the achievement of these effective doses, and thus these heartening results. The full article, authored by Dr. Sant P. Chawla et al., is now available online (
Molecular Therapy, Oct 13, 2009; see Advance Online Publications:
www.nature.com/mt/).
Epeius Biotechnologies Corporation Expands its Rexin-G Production Facilities in Southern California