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TG Therapeutics, Inc. Announces FDA Clearance To Commence Clinical Trials Of Its Novel, PI3K-Delta Specific Inhibitor, TGR-1202, Under Its Recently Filed U.S. Investigational New Drug (IND) Application
NEW YORK, Jan. 3, 2013 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (TGTX) today announced that the U.S. Food and Drug Administration ("FDA") has cleared its Investigational New Drug ("IND") Application for TGR-1202, the Company's novel, highly specific PI3K-Delta inhibitor being developed jointly with Rhizen Pharmaceuticals, S A.
"This is an exciting way to start the new year. TGR-1202 holds great promise and this is the first step to determining its true potential. We look forward to opening our first-in-human clinical trial as soon as possible," stated Michael S. Weiss, Executive Chairman and Interim CEO of TG Therapeutics, continuing, "The great speed at which the team moved to achieve this milestone for TGR-1202 is extremely impressive considering our global development agreement was just recently executed in the 3
rd quarter of 2012. Our team is eager to continue this aggressive pace as we implement the clinical development program planned for TGR-1202."
TGR-1202 is a highly specific, orally available, PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of PI3K. Inhibition of PI3K delta signaling with TGR-1202 has demonstrated robust activity in numerous pre-clinical models and primary cells from patients with hematologic malignancies. TG Therapeutics, Inc. and Rhizen Pharmaceuticals, SA are jointly developing TGR-1202 on a worldwide basis, excluding India.
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two advanced therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, third generation monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG-1101 is currently under clinical development for patients with hematologic malignancies. TG Therapeutics is also developing TGR-1202, a highly specific, orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-lymphocytes. TG Therapeutics is headquartered in New York City.