SILVER SPRING, Apr 01, 2014 (GLOBE NEWSWIRE via COMTEX) — Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has signed a Master Services Agreement with Translational Drug Development (TD2) pursuant to which TD2 will conduct preclinical and clinical studies in support of the development of Nuvilex’s pancreatic cancer and other treatments utilizing Cell-in-a-Boxtechnology.
“The Nuvilex team presents us with a new tool to employ against the symptoms and invasive properties of this very challenging cancer,” said Daniel D. Von Hoff, M.D., Chief Development Officer of TD2. “Our Pancreatic Cancer Research Team (PCRT) colleagues are enthusiastic to begin clinical trials with this approach.”
The PCRT, an affiliate of TD2, has the explicit mission to organize and accelerate the clinical development of new agents for the treatment of patients with pancreatic cancer. The PCRT members include laboratory and clinical researchers in the U.S. and Western Europe who share the passion to bring new advances to patients with pancreatic cancer as rapidly as possible, providing the only coordinated effort in the world dedicated to rapidly translating research discoveries into new treatments and supportive care for pancreatic cancer patients exclusively. To date, the PCRT consists of approximately 65 Oncology Clinicians, Surgeons and Researchers who are member-investigators of the PCRT and who represent 45 clinical research sites.
In commenting on TD2’s work with Nuvilex, Kenneth L. Waggoner, Chief Executive Officer and President of Nuvilex, stated, “We are honored that TD2 and Dr. Von Hoff will play a pivotal role in the development of our treatment for patients with advanced pancreatic cancer that combines the proprietary Cell-in-a-Box live-cell encapsulation technology with the cancer drug ifosfamide. TD2 integrates world-class preclinical, clinical and regulatory expertise and provides unique drug development services aimed at minimizing the risk for its clients in the oncology drug development industry. In addition, access to the PCRT that is enabled by our association with TD2 will not only make Nuvilex’s approach widely known, but should facilitate its development as we move forward. The sincere interest in our advanced pancreatic cancer treatment that has been shown by TD2 is particularly rewarding to all of us.”
TD2 is a precision oncology Contract Research Organization (CRO) that provides innovative services for oncology-focused biopharmaceutical companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening diseases. TD2 has managed and conducted more than 60 early-mid phase clinical studies and has worked with more than 350 biotech and pharmaceutical companies worldwide.
TD2 has facilities for the preclinical and clinical testing of candidate cancer drugs and treatments, as well as expertise in regulatory affairs matters with agencies such as the FDA. TD2 has more than 200 established models of human cancers available for preclinical studies and develops comprehensive drug development plans for the most efficient pathway for successful clinical trials. In addition, TD2 has capabilities and expertise in all aspects related to the conduct and management of clinical trials. TD2’s drug regulatory affairs capabilities include the preparation and maintenance of Investigational New Drug Applications (INDs) that are necessary prior to the initiation of clinical trials, support for obtaining “breakthrough” designations and “fast track, priority review and accelerated approval” filings for cancer drugs and treatments. The TD2 team has collective experience in filing more than 60 INDs in the U.S. alone. In countries outside the U.S., TD2 can provide filing and maintenance services for Clinical Trial Applications and Investigational Medicinal Product Dossiers.
Nuvilex is a clinical-stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live-cell encapsulation technology, called Cell-in-a-Box. This unique technology will be used as a platform upon which treatments for several types of cancer, including advanced, inoperable pancreatic cancer, and diabetes are being built. Nuvilex’s treatment for pancreatic cancer involves the widely used anticancer prodrug, ifosfamide, together with encapsulated live cells that convert ifosfamide into its active or “cancer-killing” form.
In addition to what is set forth above about Translational Drug Development (TD2), TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory and clinical expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations most likely to benefit from a new agent and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit: www.td2inc.com.
This press release may contain forward-looking statements regarding Nuvilex and its future events and results that involve inherent risks and uncertainties. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan” and similar expressions, as they relate to Nuvilex or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of Nuvilex, that could cause actual results to differ materially from those set forth in the forward-looking statements include Nuvilex’s ability to continue as a going concern, delays in clinical trials or flaws or defects regarding its products, changes in relevant legislation or regulatory requirements, uncertainty of protection of Nuvilex’s intellectual property and Nuvilex’s continued ability to raise capital. Nuvilex does not assume any obligation to update any of these forward-looking statements.