Business
Kalytera Issues CEO Letter to Shareholders
Kalytera Issues CEO Letter to Shareholders.
About this update from Claritas Pharmaceuticals Inc.
[{"type":"text","content":"\n\n Announces Meeting with FDA to Obtain Consent for Start of Phase 3 Pivotal Registration Study in Treatment of Acute GVHDAndProvides Corporate Update and Outlook for 2018\n SAN FRANCISCO and TEL AVIV, Israel, April 26, 2018 (GLOBE NEWSWIRE) -- Kalytera Therapeutics, Inc. (TSX VENTURE:KALY) (OTCQB:KALTF) (the \"Company\" or \"Kalytera\") today issued the following letter to shareholders from the Company’s President and CEO, Robert Farrell. Dear Kalytera Shareholders, I would like to provide an update, describe our business strategy, and express my gratitude for your support of the work Kalytera is doing. Our Business – CBD and Proprietary CBD Analogues Kalytera is developing cannabidiol (\"CBD\") pharmaceuticals.  We are also developing pharmaceuticals made with our proprietary CBD analogues, which are patent pending variations of CBD and CBD conjugates. Kalytera and a small number of other companies are developing CBD for the treatment of various diseases and disorders, and, importantly, we expect that one of these other companies may receive the first ever approval of a CBD pharmaceutical product later this year. This approval could provide validation of CBD’s safety and effectiveness, and we would view this as a very positive development for Kalytera. We are a Leader in the Field – We Expect Our Phase 3 Study to Start Later this Year Our program evaluating CBD in the prevention of graft versus host disease (\"GVHD\") is in late-stage clinical testing, and we have scheduled a meeting with the FDA’s Division of Hematology Projects to obtain consent to initiate a Phase 3 pivotal registration study in treatment of acute GVHD later this year. The Commercial Opportunity in GVHD is Large GVHD is a multisystem disorder that is a life-threatening complication commonly occurring after bone marrow transplant procedures. GVHD occurs when the transplanted donor cells attack the patient’s organs, including the skin, gastrointestinal tract, liver, lungs and eyes. GVHD is associated with acute and chronic illness, infections, disability, reduced quality of life and death. The commercial opportunity for Kalytera’s CBD products in the treatment and prevention of GVHD is large. According to the January 2018 Market Forecast Report by DelveInsight Perspective, projected annual sales in the 7 major ...