RESEARCH TRIANGLE PARK, NC--(Marketwire - November 02, 2011) - SCYNEXIS, Inc., PharmaDirections, Inc. and TAU Therapeutics have collaboratively developed an innovative API synthetic process for mibefradil which will allow TAU to begin their Phase 1 clinical trials.
TAU Therapeutics is developing mibefradil for the treatment of cancer. Mibefradil is a previously marketed T-type calcium channel blocker which has a demonstrated ability to arrest tumor cells at their most vulnerable metabolic point -- the G1/S checkpoint -- uniquely amplifying the effects of conventional radiation and chemotherapies and overcoming drug resistance. Sequential administration of mibefradil with potent anti-cancer treatments (such as Temozolomide) has demonstrated a dramatic increase in lifespan in preclinical animal models of glioblastoma multiforme (GBM). TAU Therapeutics' proprietary Interlaced Therapy™ platform has potential to treat multiple solid tumor types by synchronizing the cell cycle of proliferating cells and enhancing the efficacy of cytotoxic cancer chemotherapeutics.
"We are thrilled to work with such an outstanding team to develop our first in-class oncology product. SCYNEXIS proved once again its extraordinary strength in chemistry and project management," said Andrew Krouse, chief executive officer and co-founder of TAU Therapeutics.
SCYNEXIS and PharmaDirections have been involved in the process and analytical development and GMP manufacturing of mibefradil since 2010. Their challenge was to develop a new synthetic route for the drug. Part of the process development program required SCYNEXIS to make significant improvements over the published synthetic scheme in order to minimize or eliminate impurities seen in the original manufacturing process.
The resulting optimized process significantly improved the purity enabling TAU Therapeutics to expeditiously file the CMC sections and IND for a number of clinical studies using mibefradil. Working together with SCYNEXIS, PharmaDirections provided their medicinal chemistry and project management expertise along with Tim McDonald, the CSO at TAU Therapeutics to bring about a successful conclusion to the project.
"We are gratified to have been able to play a significant role in moving forward this innovative approach to cancer treatment," said Yves Ribeill, president and chief executive officer of SCYNEXIS. "This project demonstrated that collaborating partners can achieve breakthrough science with new approaches to drug discovery and development."
"This was an excellent example of how scientific teams can interact to overcome complex challenges and deliver a quality product," said Dr. Rick Soltero, president of PharmaDirections.
PharmaDirections has managed TAU Therapeutics' IND enabling program including CMC projects, IND regulatory filings and clinical development since early 2010. PharmaDirections also played a key role in coordinating contract research organizations on behalf of TAU Therapeutics and ultimately evaluating and managing all external contract research, development, manufacturing and clinical activities.
About TAU Therapeutics
TAU Therapeutics is a clinical stage biopharmaceutical company committed to providing patients with a better way of treating cancer through the development of calcium T-channel therapeutics. TAU is the world leader in developing calcium T-channel products for the treatment of cancer and other indications. TAU's novel, targeted Interlaced Therapy™ platform utilizes cell cycle synchronization technology and traditional chemotherapies to inhibit the growth of cancer cells. Ultimately, Interlaced Therapy™ magnifies the effects of chemotherapy on cancer cells while preserving healthy cells. It is TAU's goal to usher in Interlaced Therapy™ as a new standard of care for all solid tumor cancers. From the bench to the bedside, TAU is working diligently both to expand Interlaced Therapy™ to all solid tumor cancers and simultaneously further the development of its novel technologies and compounds.
TAU Therapeutics is based in Charlottesville, VA and was spun out of the University of Virginia. To learn more, please visit www.TAUTherapeutics.com
About SCYNEXIS, Inc.
SCYNEXIS delivers integrated, efficient and innovative drug discovery and development solutions to our global health and pharmaceutical partners. Our record of success is exemplified by the delivery of eleven pre-clinical drug candidates over the last five years. SCYNEXIS' fully-integrated contract research and development services include medicinal chemistry, advanced biological screening, in vitro pharmacology and ADMET, DMPK, bioanalytical and analytical chemistry, process chemistry and cGMP manufacturing. The SCYNEXIS process chemistry department recently passed a general inspection and pre-approval inspection (PAI) by the FDA in support of a customer's NDA.
Founded in 2000, SCYNEXIS is located in Research Triangle Park, N.C. SCYNEXIS is registered with both the FDA and DEA. To learn more, please visit www.scynexis.com.
PharmaDirections offers the highest level of scientific and management expertise to transform new technologies into successful drug products. The company provides consulting and project management with a unique approach to managing preclinical, CMC and regulatory affairs programs. The company provides strategic planning and oversees and directs pharmaceutical contract research using its own scientific experts and project managers at partner laboratories who are our sub-contractors.
PharmaDirections is a comprehensive R&D resource for pharmaceutical and biotech companies who need more than just outsourcing of their API or drug product development and manufacturing. To learn more, please visit www.PharmaDirections.com.