MOUNTAIN VIEW, California, and SYDNEY, Australia, May 16, 2011 /PRNewswire-iReach/ — TheraVida, Inc., a clinical stage biopharmaceutical company developing novel combination drug products, announced the start of a Phase 2 clinical trial of its lead product candidate THVD-201 for the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI). Novotech, a leading Asia Pacific contract research organization, has been selected to manage the study for TheraVida.

See full announcement here

The team aims to commercialize a novel treatment for Herpes simplex and Herpes zoster utilizing an extract from the blood of black lip abalone Haliotis ruber. The project is expected to cost $1.2M in cash and in-kind support over three years.

ARC, which fosters academic-industry research collaborations, has made the funding available for research into the abalone derived haemocyanin product.

MBA, a Tasmanian based company, has been researching the novel glycoprotein with antiviral activity for the past five years. Novotech has been working with MBA for three years.

The new research collaboration with the University of Sydney under the ARC agreement is underway and is expected to move to human clinical trials in mid 2011.

MBA Managing Director Adrian Cuthbertson said: “An 18 month development study undertaken by Sydney based Protech Ltd on behalf of MBA had identified significant anti viral activity associated with the abalone blood extract and may be effective in the treatment of certain viral infections such as the Herpes simplex (HSV1 and HSV2 and Herpes zoster (Shingles).”

The ARC grant will also look at the development of the abalone respiratory molecule as a carrier for use in research and vaccine production.

Novotech CEO Alek Safarian said Novotech was looking forward to progressing with the research, which will run through to 2013.

“Novotech is providing regulatory and clinical advisory services to support clinical research and will design the clinical trials program to determine the proteins’ potential as the basis for a new drug,” said Safarian.

About Novotech

Headquartered in Sydney with a regional hub in Malaysia, Novotech is focused on the Asia Pacific region with operations in eight countries including India and South Korea. Novotech also has worldwide reach through the company’s network of strategic partners. Novotech, described by Frost & Sullivan as the best in its industry class for Australia based CROs, brings its global reputation for high quality service and regional expertise to the high-growth Asia Pacific area. As the largest independent CRO based in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organizations in the region. Since 2006, Novotech has been recognized as Australia’s leading CRO by Frost & Sullivan in its Asia Pacific Excellence in Healthcare awards. For more information, please visit www.novotech-cro.com.

ABOUT MBA P/L

Marine Biotechnology Australia Pty Ltd was established with private investment funds in 2005 with a view to developing anti cancer and anti viral products from abalone extracts. An initial joint venture with the German company Biosyn Corporation looked at the use of abalone hemocyanin in the treatment of post operative bladder cancer. Whilst the results were positive it was a study conducted at The Department of Immunology at the University of Tasmania on behalf of MBA that attracted the most attention. With the aid of an Aus Industry matching dollar for dollar grant the company contracted the University of Tasmania to study the immunogenic effect of  abalone hemocyanin. The first indications that abalone hemocyanin could be beneficial in the treatment and prevention of HSV arose from this study and has been the catalyst for further work by Protech and the University of Sydney. To date MBA has invested over $3million in the project with a further $1.5 million budgeted for the current financial year.

ABOUT ARC www.arc.gov.au

The ARC is a statutory authority within the Australian Government’s Innovation, Industry, Science and Research (IISR) portfolio. Its mission is to deliver policy and programs that advance Australian research and innovation globally and benefit the community.

In seeking to achieve its mission, the ARC provides advice to the Government on research matters and manages the National Competitive Grants Program (NCGP), a significant component of Australia’s investment in research and development.

Sydney, Australia, 29 October 2010 – Novotech has announced initiation of three Phase Ib oncology trials at sites in Australia and New Zealand to test the safety, efficacy and pharmacokinetics of client OncoMed’s humanized monoclonal antibody product designed to target cancer stem cells.

Novotech, a leading Australian contract research organization, employing cutting edge technologies in electronic data capture and clinical trial management systems, will manage the trials for OncoMed.

Three separate trials will recruit patients with pancreatic cancer, advanced colorectal cancer, and non-squamous non-small cell lung cancer (NSCLC).

Dr. Steve Benner, Senior Vice President and Chief Medical Officer of OncoMed  Pharmaceuticals, a Redwood City, California based biotechnology company said Novotech was appointed for its local regulatory knowledge and site selection and data management expertise.  “We have been very impressed with our colleagues at Novotech and look forward to collaborating closely with them on these important trials,” said Dr. Benner.

Novotech CEO Alek Safarian said the Novotech team, has initiated the trials and enrollment has begun.

OncoMed Pharmaceuticals is a US-based clinical-stage company that discovers and develops novel therapeutics targeting cancer stem cells, the cells believed to be capable of driving tumor growth, recurrence and metastases. A leader in cancer stem cell research, the company has established a library of antibodies  to cancer stem cell proteins associated with tumors such as pancreatic, breast, colorectal and lung cancers. OncoMed’s lead candidate, OMP-21M18 is currently in Phase Ib clinical trials and has a pipeline of several preclinical product candidates targeting multiple cancer stem cell pathways.

About Novotech

Headquartered in Sydney with a regional hub in Malaysia, Novotech is focused on the Asia Pacific region with operations in nine countries including India and South Korea. Novotech also has worldwide reach through the company’s network of strategic partners. Novotech, described by Frost & Sullivan as the best in its industry class for Australia based CROs, brings its global reputation for high quality service and regional expertise to the high-growth Asia Pacific area. As the largest independent CRO based in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organizations in the region. Since 2006, Novotech has been recognized as Australia’s leading CRO by Frost & Sullivan in its Asia Pacific Excellence in Healthcare awards. For more information, please visit www.novotech-cro.com.

News Facts

• Novotech, the largest independent clinical research organisation in Australia, has selected Oracle’s Siebel Clinical Trial Management System to support the company’s complete spectrum of clinical drug development and research.
• Novotech works with leading biotechnology and pharmaceutical companies to bring new healthcare products to the global market by offering a broad range of compliant clinical services. The company is headquartered in Australia with operations in India, New Zealand, South Korea and across Southeast Asia. The company has helped global customers conduct trials across a population base of more than 1.5 billion people in the Australasian region alone from first human exposure through to completion of Phase III trials.
• Novotech has been running a bespoke system to manage their clinical trial operations.  Over time, the business has grown and expanded across the Asia Pacific rim. The existing system did not accommodate the evolving business needs of Novotech as it lacked scalability and flexibility.
• In order to support the company’s continued growth and an increasingly complex business, Novotech needed a system that was robust and could grow with their operations.
• Novotech selected Siebel Clinical Trial Management because it met the organisation’s present needs, is a recognised leader and is built on open standards allowing the company to integrate other business applications, such as its financial system.
• Siebel Clinical Trial Management will also serve as a centralised repository for all investigators to collect and track relevant information about research, including personal profiles to disease specialities. Information will be readily available to manage clinical trials at different tiers – local, regional and global.
• Siebel Clinical Trial Management will offer a consistent view of the clinical trials undertaken by Novotech and provide up to date information on clinical trial statuses across the organisation. Furthermore, Siebel Clinical Trial Management will provide a common platform that will assist Novotech to conduct their activities to achieve operational efficiencies.
• In addition to managing the end-to-end trial management process, Siebel Clinical Trial Management will assist to provide timely and accurate reports and dashboards to support tactical and strategic decision making.
• Novotech expects to see improved process efficiencies, better trial quality and lower trial costs from the implementation. Plans are underway to integrate Siebel Clinical with Novotech’s finance system. This will help streamline the business and support real time and accurate reporting, enabling traceability and auditability, and helping reduce the risk of errors due to manually entered information.

Supporting Quotes

• “As we continue to expand, we need a system that can grow with our business operations and support our ability to run successful clinical trials across the globe. Novotech’s investment in this field with industry leading technology systems like Oracle’s Siebel Clinical showcases our efforts to be recognised as a world-class CRO, “said Alek Safarian, CEO Novotech Australia.
• “Oracle’s Siebel Clinical Trial Management System is a proven solution for managing successful clinical trials. We are pleased that Novotech recognises the benefits it provides in supporting the company’s ongoing and future clinical drug development and research,” said Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences.

Supporting Resources

• Siebel Clinical Trial Management System
• Oracle in Life Sciences
• Oracle Health Sciences on Twitter
• Join the Oracle Health Sciences Community on Facebook

About Novotech

Headquartered in Sydney with a regional hub in Malaysia, Novotech is focused on the Asia Pacific region with operations in nine countries including India and South Korea. Novotech also has worldwide reach through the company’s network of strategic partners. Novotech, described by Frost & Sullivan as the best in its industry class for Australia based CROs, brings its global reputation for high quality service and regional expertise to the high-growth Asia Pacific area. As the largest independent CRO based in Australia, Novotech offers a level of flexibility and local knowledge that is unmatched among other contract research organisations in the region. Since 2006, Novotech has been recognised as Australia’s leading CRO by Frost & Sullivan in its Asia Pacific Excellence in Healthcare awards. For more information, please visit www.novotech-cro.com.

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