4/22/2014 2:25:22 PM
Brisbane, Australia, April 22, 2014 - Clinical Network Services (CNS) Pty Ltd, an integrated product development company based in Australia, New Zealand and the UK providing broad services in the planning, implementation and delivery of preclinical, Phase 1 and 2 trials, today announced that it has been contracted by Nuvilex, Inc. (OTCQB: NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, to supply Australian clinical and global regulatory services in support of Nuvilex’s “Cell in a Box™ Technology.”
CNS will be providing a full complement of clinical trial planning and management services on Nuvilex’s Phase IIb study in pancreatic cancer patients to be conducted in Australia. In addition to the clinical trial, CNS, through its BioDesk group, will immediately be providing consultancy and management services to Nuvilex as part the implementation of Nuvilex’s global regulatory strategy, including applications for Orphan Drug Designation from the EMA, the US FDA and the Australian TGA in the near term.
The Managing Director of CNS, Russell Neal, commented, “Nuvilex’s Cell-in-a-Box™ call encapsulation offers a wholly new treatment modality for the treatment of pancreatic cancer and we are excited to have been selected to support its clinical development and provide global regulatory support.”
“The work we are embarking upon with CNS is an important milestone for Nuvilex, as it represents the next step in proving the value of our Cell-in-the-Box technology and the potential of a better treatment for pancreatic cancer,” said Kenneth L. Waggoner, CEO and President of Nuvilex. “CNS’s rich history and familiarity with our treatment from the previous Phase 1/2 clinical trials, as the CRO in charge of the early stage trials, will greatly facilitate preparations for the Australian trials and bring us closer to a potential solution.”
Nuvilex is a biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live-cell encapsulation technology, known as Cell-in-a-Box®. This unique and patented 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 which convert ifosfamide into its active or “cancer-killing” form. Nuvilex is also involved in clinical trials related to other aspects of pancreatic and other forms of cancer. Nuvilex’s subsidiary, Medical Marijuana Sciences, Inc., is dedicated to the development of cancer treatments based upon chemical constituents of marijuana known as cannabinoids. To do so, it will examine ways to exploit the benefits of Cell-in-a-Box® technology in optimizing the anticancer effectiveness of cannabinoids against cancers while minimizing or outright eliminating the debilitating side effects usually associated with cancer treatments. This provides Medical Marijuana Sciences a unique opportunity to develop “green” approaches to fighting deadly cancers, such as those of the pancreas, brain, breast and prostate, that affect hundreds of thousands of individuals worldwide every year.
About Clinical Network Services
Clinical Network Services (CNS) Pty Ltd is an Australian, New Zealand and UK CRO offering integrated development services to virtual, small and medium sized Biotech companies in the planning, implementation and delivery of Phase 1 and 2 trials, and beyond. CNS offers a unique service where it integrates BioDesk, an intelligent product development planning and regulatory affairs service, with our committed, highly experienced regional clinical operations team. The CNS “Regional Advantage” is driven by our extremely pragmatic regulatory environment that makes it possible for our clients to enter the clinic quickly, without the need for prior regulatory agency approval. Specifically, BioDesk works closely with our clients to design, implement and manage manufacturing and preclinical plans that are mindful of commercial timelines and budgets, allowing swifter go/no go decisions for our clients and their investors. With operations across Australia and New Zealand, CNS makes use of its close relationships with key opinion leaders, world leading clinical facilities, and globally respected Phase I units across a wide variety of therapeutic indications. Our service offerings include: product development, regulatory affairs planning and development, clinical planning, study start up, monitoring, project management, data management, biostatistics, pharmacometrics, medical consultancy/monitoring, medical writing, bioanalytical services and safety reporting.
Further information on CNS can be found at www.clinical.net.au
BioDesk is a unique global product development and regulatory planning consultancy which assists Biotech companies get into the clinic faster through creating and managing a manufacturing and pre-clinical programme that encompasses a globalised regulatory perspective whilst leveraging unique regional advantages.
Specifically, BioDesk works closely with our clients to design, implement and manage manufacturing and pre-clinical plans mindful of commercial timelines and budgets, allowing swifter go/no go decisions for our clients and their investors.
Services offered by BioDesk include:
- Developing a forward looking Product (Drug) Development Plan
- Supporting the aggregation of pre-clinical chemistry, GMP and CMC
- Formulating development plans appropriate to venture capitalists and regulators
- Strategic regulatory advice for key international and local markets
- Support and development of regulatory submissions such as INDs, CTAs, BLAs, MLAs, etc.
- Project and programme management.
Through BioDesk, CNS offers the Biotech industry a focused approach to biotherapeutic development. When coupled with our clinical management expertise, our approach drives efficient navigation through the critical period of post-discovery planning and initial clinic testing whilst adding value to the global dossier and delivering improved commercial outcomes to our clients.
Issued for and on behalf of Clinical Network Services by Instinctif Partners.
For more information please contact:
Clinical Network Services
T: +61 (0)7 3719 6000
Media Enquiries – Instinctif Partners:
Dr. Douglas Pretsell
T: +61 (0)466 925 966
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