Today, Marshall Edwards, which is steadily breaking new ground in the field of cancer therapeutics via naturally occurring isoflavone compounds that short circuit the metabolism of cancer cells by disrupting key enzyme interactions, reported submission of an IND (investigational new drug) application to the FDA, readying to initiate clinical testing for the company's lead mitochondrial inhibitor ME-344.
ME-344 is actually a second front in MSHL's oncology campaign, as the company has also developed a second lead program focused on a different small molecule compound, ME-143, the lead candidate from a family of NADH oxidase inhibitor compounds. These two programs, focusing on two families of compounds, while related, have unique mechanism of action properties.
ME-344 pulls the plug on tumor cell metabolic processes, a mitochondrial inhibitor (and an active metabolite of first-generation compound NV-128) that bleeds out cellular energy, inhibiting both mammalian target rapamycin pathways (mTOR1/2). It is important to note that the NADH oxidase inhibitor program that spawned the next-gen ME-143 also contains first-gen Phenoxodiol, which has been well tolerated in hundreds of patients.
President and CEO of MSHL, Daniel P. Gold, Ph.D., spoke with great pride in the company's achievements to date, citing the advancement of this IND and the preparations to go into Phase I clinical trials of intravenous ME-344 (in solid refractory tumors), fast on the heels of the approval by FDA of the ME-143 IND (Aug 16, 2011).
MSHL is doing quite well in the oncology space and investors are keen to see more results from the company, which owns exclusive worldwide rights to all of its drug candidates, including the aforementioned. The Company also announced that cohort four of Phase I clinical intravenous ME-143 (also solid refractory tumors) was being dosed as per schedule, with final safety/pharmacokinetic data collection projected for this June.
Chief Medical Officer of MSHL, Robert Mass, M.D., underscored the company's continued successful execution of their clinical development strategy, pointing to this IND and the pending data burst from the ME-143 trials as evidence not only of this fact, but also the true potential of both platforms/ lead drug candidates. Dr. Mass explained that as MSHL awaits approval of the ME-344 IND and approaches completion of enrollment in the ME-143 Phase I clinical, the company was hard at work gearing up for Phase II.
With projections for the worldwide cancer market exceeding $78B in 2012 (Global Cancer Treatment Forecast to 2012 - RNCOS, one of the top global market research and information analysis shops), there is tremendous potential for such novel therapeutics as MSHL has to offer; therapeutics which target cancer cell metabolism from a robust isoflavone technology platform, a platform that has spawned numerous compounds showing anti-tumor activity in a broad spectrum of tumor cell lines. ME-143 has even shown an ability to enhance the cytotoxic effectiveness of extant chemotherapies.
For more information about today's application or either of the company's programs/candidates, please visit the Marshall Edwards, Inc. website at: www.MarshallEdwardsInc.com
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