TORONTO, ONTARIO–(Marketwired – Nov. 26, 2014) – Arch Biopartners Inc (CSE:ACH)(OTCBB:FOIFF) has now completed a Clinical Development Plan (“CDP”) to prepare a human trial for MetaMx, the Company’s brain tumour targeting technology.
The CDP was prepared in collaboration with d3 Medicine and contains detailed plans for all pre-clinical tasks including pharmacology, pharmacokinetics, manufacturing, formulation and toxicology of MetaMx. Arch Biopartners management intends to have these tasks completed in 2015.
A pre-Investigational New Drug (“IND”) meeting with the Food and Drug Administration (FDA) is planned upon availability of toxicology data and a synopsis of the planned Phase I study for MetaMx for patients with malignant glioma. Toxicology is expected to commence in mid- 2015 and take about 12 weeks.
Upon completion of a pre-IND meeting, it is planned to move ahead with the filing of the IND application and execution of the MetaMx Phase I trial using a single center in the U.S.
About MetaMx and Malignant Glioma
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.
Arch intends to perform a 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 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.
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 lead technology is MetaMx. 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.
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