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news.Arch Biopartners Inc has now completed a Clinical Development Plan (CDP) to prepare a human trial for MetaMx, the Company's brain tumour targeting technology.
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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.
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.