TORONTO, ONTARIO–(Marketwired – May 29, 2014) – Arch Biopartners Inc (Arch) or (the Company) (CSE:ACH)(OTCBB:FOIFF) announced today it has hired d3 Medicine to work as the Company’s new drug development team.
d3’s first task will be to design a Phase I/II human trial for MetaMx, the Company’s brain tumour targeting technology, in patients with malignant glioma.
“The engagement of d3 Medicine instantly brings to Arch a multifunctional team experienced in toxicology, clinical pharmacology, regulatory affairs and business development,” said Richard Muruve, CEO of Arch.
Arch intends to perform this human trial to characterize the safety and pharmacokinetics of MetaMx and to demonstrate the efficacy of MetaMx to cross the human blood brain barrier and detect brain tumor initiating cells (BTICs) and invasive glioma cells. Such results in human patients will increase the value of MetaMx not only as a diagnostic and imaging tool but also as a potential drug delivery platform to destroy BTICs and invasive glioma cells.
d3 Medicine will deliver a detailed clinical development plan up to and including the key elements of the first human trial: Chemistry, Manufacturing and Controls (CMC), regulatory strategy and toxicology.
Leading the d3 team is Dr. Patrick Smith, D3’s Chief Science Officer and former head of US Clinical Pharmacology for Roche. Dr. Michael Taylor, Founder and Principal at NonClinical Safety Assessment, will be responsible for planning the toxicology needs of MetaMx.
Dr. Krishnan Viswanadhan, will have the Regulatory Lead for MetaMx. Dr. Viswanadhan is Vice President of Advyzom, a leading regulatory affairs boutique consulting company.
Craig Rayner, D3’s CEO and a former Global Due Diligence leader at Roche, will oversee due diligence, peer review and provide valuable drug development experience. Joining Dr. Rayner in this regard is Dr. Regina Dutkowski whose past appointments include Global Development Team Leader, Roche.
Dr. Vis Niranjan, d3’s Chief Medical Officer, is a U.S. licensed physician-scientist with many years of broad drug development experience. Dr. Niranjan will provide in depth clinical experience to the development of MetaMx and the preparation of the first human study.
About Malignant Glioma and MetaMx
Worldwide, there are approximately 70,000 new patients with malignant glioma each year and clinical outcomes for these patients have not changed substantially over the past 30 years. Average survival rates remain at a dismal 12-15 months and long term survivors (i.e. those surviving more than 3 years) are rare.
This poor survival rate is linked to brain tumour initiating cells (BTICs) and invasive glioma cells which represent disease reservoirs that are not detectable using current diagnostic techniques as they are indiscernible from normal tissue. As a result, these cells are usually left behind in brain tissue post surgery and often lead to tumour relapse and poor patient outcomes.
Therefore, a significant unmet medical need and commercial opportunity is the ability to target BTICs and invasive glioma cells for the purpose of imaging, diagnosing and developing targeted therapies to improve patient outcomes and survival rates.
MetaMx is comprised of proprietary molecules that target both BTICs and invasive glioma cells. The lead inventors of MetaMx are Dr. Stephen Robbins, Dr. Donna Senger and Dr. Jennifer Rahn at the University of Calgary.
About D3 Medicine
d3 Medicine (www.d3medicine.com) was created to provide the biopharmaceutical industry, non-profit sector, and government agencies with access to a team of contemporary drug development experts. With a strong track record of delivering genuine commercial and therapeutic impact, d3’s team members are globally recognized as industry leaders. d3 consists of experienced executives supported by an agile global network of experts with aligned values, providing state of the art integrated perspectives effectively and efficiently.
For full biographies of the d3 team members above please visit: http://www.d3medicine.com/who-we-are/leadership
About Arch Biopartners
Arch Biopartners is a portfolio based biotechnology company established to develop new products and technology for sale to pharmaceutical and industrial companies. The Company’s website address is: www.archbiopartners.com.
For more information on the Company, please consult the other public documents filed on SEDAR at www.sedar.com.
All statements, other than statements of historical fact, in this news release are forward looking statements that involve various risks and uncertainties, including, without limitation, statements regarding the future plans and objectives of the Company. There can be no assurance that such statements will prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. The Company assumes no obligation to update forward-looking statements should circumstances or management’s estimates or opinions change.
The CSE has not reviewed and does not accept responsibility for the adequacy of this release.