Tau Therapeutics and PharmaDirections Team Up To File IND for Innovative Cancer Therapy Using Mibefradil for Interlaced Cytostatic Checkpoint Therapy

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TAU Therapeutics, LLC and their preclinical development partner, PharmaDirections, Inc. worked together to file an IND for a novel cancer therapy.

Interlaced Cytostatic Checkpoint Therapy (CCT)

This is a great example of a virtual company using outsourced resources to their maximum advantage” said Dr. Richard Soltero, President of PharmaDirections.

TAU Therapeutics developed and patented a proprietary therapeutic approach called Interlaced Cytostatic Checkpoint Therapy™ (CCT), which is designed to inhibit cancer cell growth at the G1/S checkpoint by use of mibefradil, a selective T channel or Cav3 calcium channel antagonist. When mibefradil therapy is interrupted, the cancer cells proceed into the S phase or cell division where the cytotoxic agent exerts its maximal effect. Nonclinical models demonstrated that an integrated sequence of mibefradil combined with a standard chemotherapeutic can potentiate the selective cytotoxicity by holding cells at the pre-S phase.

Since this concept has been confirmed in numerous nonclinical studies using several cancer cell lines and animal models, the potential clinical utility of mibefradil administered in a sequence combined with a chemotherapy agent such as temozolomide may be a significant step in managing glioblastoma.

“We are very excited to see our IND filed” said Andy Krouse, CEO of Tau Therapeutics. “We are planning multiple trials in GBM and have support from several leading cancer foundations such as the Adult Brain Cancer Trust.”

PharmaDirections provided the strategic development plan for Tau Therapeutics and has provided the preclinical and formulation development services needed for their program. PharmaDirections and Tau worked together to resolve many difficult development challenges using their joint scientific expertise, advanced software tools and collaborations with other vendors. They solved the problem of determining starting doses and dosing regimen using pharmacokinetic modeling and PharmaDirections' expertise with GastroPlus. PharmaDirections collaborated with their API manufacture, Scynexis, to develop a manufacturing scheme staring with the published scheme and ending up with a new route that has significant improvements and the potential for new intellectual property.

PharmaDirections managed TAU Therapeutic’s IND enabling program including CMC projects, IND regulatory filings and formulation 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. 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 http://www.TAUTherapeutics.com

About PharmaDirections
Founded in 2003, PharmaDirections is a pharmaceutical consulting and project management company focused on providing preclinical, CMC and regulatory affairs services to the biotech community. They offer the highest level of scientific and management expertise to transform new technologies into successful drug products. 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 their sub-contractors.


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Justin Pittman

Andy Krouse
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