AMRITA THERAPEUTICS REQUESTS MEETING WITH US FDA FOR PHASE I ONCOLOGY CLINICAL TRIAL; COMPANY’S COMPANY’S 1ST IN HUMAN STUDY TO DEFINE SAFETY, PRELIMINARY EFFICACY OF AT-01C

On March 16, 2016 Amrita Therapeutics ("the Company"), a biopharmaceutical company developing innovative technologies from the microbiome, reported that it is pleased to announce its submission to the FDA of a pre-INDType B Meeting request for discussion of development plans for the Company’s lead oncology peptide AT-01C (Press release, Amrita Therapeutics, MAR 16, 2016, View Source [SID:1234512730]).

Amrita Therapeutics’ AT-01C peptide demonstrates p53 ("guardian of the genome") tumor suppression and binds to the SMAR1* protein for down-regulation of oncogenes with little or no toxicity to healthy tissues, with effectiveness against solid tumors including genitourinary, gastrointestinal (GI), liver and CNS cancers. In parallel to clinical development of AT-01C, the Company is focusing on the ‘master regulator’ SMAR1 biomarker as a companion diagnostic test to identify patients most likely to benefit from AT-01C therapy.

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Susan K. Finston, Amrita Therapeutics’ Chief Executive Officer notes, "we continue to gain insights into the extraordinary therapeutic potential of peptides from the microbiome and look forward to clinical development of AT-01C to address unmet needs of cancer patients."

With less toxicity and fewer side effects, naturally occurring peptide drugs have a greater likelihood of regulatory approval double that of small molecule new chemical entities (NCEs) for a range of indications including infectious diseases, metabolic disorders and advanced cancer therapies. Amrita’s first peptide drug has the potential to reach sales in excess of $ 1 billion within the first years of launch.