Tragara Reports Interim Results of Phase 1b Study of TG02 and Carfilzomib in Multiple Myeloma

Print 06 December 2014

TG02 demonstrates ability to mobilize difficult-to-kill leukemic stem cells and render them vulnerable to chemotherapy.

San Diego, California (PRWEB) December 06, 2014 -  Tragara Pharmaceuticals, Inc. today announced that a poster on TG02, the Company's unique oral multi-kinase inhibitor, will be presented at the American Society of Hematology (ASH) 2014 Annual Meeting (December 6-9, 2014) in San Francisco.

Researchers from the Weill Medical College of Cornell University will present a poster entitled “In Vivo Treatment With TG02 Results in Increased Mobilization and Sensitization of Leukemia Stem Cells to Chemotherapeutic Agents”. In acute leukemia, leukemic stem cells comprise a largely quiescent, highly chemotherapy-resistant cell population that contributes to the initiation, propagation and relapse of the disease. The data show that TG02 induces an effect on leukemic stem cells, or their niche, that results in their mobilization to the periphery. Furthermore, the addition of cytarabine to TG02 produced a significant decrease in both marrow and peripheral blood leukemia cells, suggesting that treatment with TG02 may sensitize these typically chemotherapy-resistant cells to chemotherapy. The poster (#3765) will be shown on Monday, December 8, 2014, from 6:00PM - 8:00PM in the North Hall of Building E of the Moscone Center.

Based on the results of this research, the Company is in discussions with MD Anderson Cancer to design a clinical study to evaluate the activity of TG02 in combination with a hypomethylating agent in patients with acute myeloid leukemia. The study will be conducted by MD Anderson with support from Tragara.

“The difficulty of eliminating quiescent leukemic stems cells with existing cancer agents has been a significant obstacle in the advancement of treatment options for acute leukemia patients,” said Elias Jabbour, M.D. Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center. “The preclinical data observed with TG02 is very encouraging and I am eager to see this research duplicated in the clinic”.

About TG02 
TG02 is a unique, oral multi-kinase inhibitor which combines the benefits of inhibiting important cyclin dependent kinases (CDK’s) equipotently with JAK2, FLT3, and ERK5 inhibition. TG02 exerts its antitumor activity primarily via its potent CDK9 inhibition, which leads to the depletion of key survival proteins, such as Mcl-1, resulting in p53-independent apoptosis of a wide range of tumor cells. TG02 development will initially focus on the treatment of hematologic malignancies, including multiple myeloma (MM) and chronic lymphocytic leukemia (CLL), based on the consistent anti-tumor activity that has been observed across a broad spectrum of hematologic cancer models, including those resistant to currently available therapies. In these models, TG02 demonstrated both single agent activity and synergy when administered with current standard of care therapies. Subsequent development will focus on an important group of solid tumors with unmet medical need, such as small cell lung cancer, triple negative breast cancer, and melanoma, which will also benefit from this mechanism of action, complemented with the benefits of inhibiting both JAK2 and ERK5, and depleting other CDK9-dependent proteins such as c-MYC and VEGF. These pathways affect disease progression and survival in hematologic malignancies and solid tumors.

TG02 is currently being evaluated in two separate phase I clinical trials in patients with MM and CLL in the United States.

About Tragara 
Tragara Pharmaceuticals, Inc. is a privately held pharmaceutical company based in San Diego, California. The company is focused on the clinical and commercial development of proprietary medicines for the treatment of cancer. TG02 is a unique, oral multi-kinase inhibitor which combines the benefits of inhibiting important cyclin dependent kinases equipotently with JAK2, FLT3, and ERK5 inhibition. TG02 exerts its antitumor activity via its potent CDK9 inhibition, which leads to the depletion of key survival proteins, such as Mcl-1, resulting in p53-independent apoptosis of a wide range of tumor cells. Tragara is managed by a team of entrepreneurs with both Big Pharma and Biotech experience in the development and commercialization of oncology therapeutics. Its investors include: Domain Associates, Mitsubishi International Corporation, Morgenthaler Ventures, ProQuest Investments and RusnanoMedInvest.

Tragara strives to provide much-needed therapies that will contribute to patient health through better survival and an increase in the quality of life. For more information, visit http://www.tragarapharma.com.

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