Navigation Links
Tragara Initiates Clinical Study of TG02 in Combination with Carfilzomib in Multiple Myeloma
Date:12/3/2013

San Diego (PRWEB) December 03, 2013

Tragara Pharmaceuticals, Inc. today announced the initiation of a phase 1b clinical trial of TG02, in combination with the poteosome inhibitor carfilzomib (Kyprolis®), in patients with relapsed or refractory multiple myeloma. TG02 is a potent oral inhibitor of CDK9, which leads to the depletion of key survival proteins, such as Mcl-1, resulting in p53-independent apoptosis across a wide range of tumor cells. The study is being led by Craig C. Hofmeister, M.D., at The Ohio State University Comprehensive Cancer Center, and is open for enrollment at multiple centers in the U.S.

This study is an open-label dose-escalation phase 1b trial in which TG02 is combined with carfilzomib in patients with relapsed or refractory multiple myeloma. The trial will include patients who have one or more cytogenetic abnormalities that predict poor prognosis and reduced responsiveness to current standard-of-care therapies, including deletion of chromosomes 17p or 1p, amplification of chromosome 1q, or the chromosomal translocation t(4:14). Patients who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent, will also qualify for enrollment. The primary objective of the trial is to determine the dose-limiting toxicity, maximum-tolerated dose, and recommended phase II dose of TG02 in combination with carfilzomib. The secondary objectives include the assessment of safety, tolerability, pharmacokinetics, and the evaluation of exploratory biomarkers, in addition to evidence of anti-tumor activity.

“A meaningful percentage of patients with multiple myeloma have disease characterized by cytogenetic abnormalities, and the prognosis for these cases is typically poor,” said Craig C. Hofmeister, M.D., Assistant Professor at The Ohio State University, College of Medicine, and principal investigator. “The treatment options for this subset of patients are limited, so we are very interested in exploring the potential of TG02, in combination with carfilzomib, in this clinical trial.”

Rationale for the Combination
Multiple myeloma cells are dependent upon the anti-apoptotic protein Mcl-1 for survival. The rationale for the combination of TG02 and carfilzomib is based on the ability of both agents to target Mcl-1 via independent mechanisms. Carfilzomib upregulates the protein NOXA, which inhibits Mcl-1 in the cell. TG02 inhibits CDK9, which downregulates the production of Mcl-1, reducing the level of Mcl-1 in the cell by blocking its replenishment. The combination of these treatments has been shown to have synergistic effects in human myeloma cell lines.

Preclinical data describing TG02 in combination with carfilzomib will be shown during a poster presentation at the American Society of Hematology Annual Meeting in New Orleans. The poster, “Dual Inhibition Of Mcl-1 By The Combination Of Carfilzomib and TG02 In Multiple Myeloma”, presents the results of work conducted by the Winship Cancer Institute of Emory University. The poster (#3171) will be shown on Sunday, December 8, at 6:30pm CST in Hall G of the Morial Convention Center.

About TG02
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 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. 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.    

In early 2010, TG02 was selected by the Multiple Myeloma Research Foundation as a winner of its Biotech Investment Award, which represents a multi-year research grant commitment to fund the early-stage drug development of novel compounds that show potential in treating MM.

About Tragara
Tragara Pharmaceuticals, Inc. is a privately held pharmaceutical company based in San Diego, Calif. 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.

Read the full story at http://www.prweb.com/releases/2013/12/prweb11386175.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1. UK initiates first cancer reporting model of its kind in US
2. South Charlotte Dentistry Initiates New Emphasis on Comprehensive Dental Treatment
3. Taglich Brothers Initiates Coverage on FluroPharma Medical, Inc.
4. HCG Drops 411 Initiates 21 Pound Guarantee
5. Grant initiates new stem cell research for patients suffering with corneal blindness
6. Targeted Medical Pharma Initiates Clinical Trial of Red Blood Cell Stimulating Formulation
7. Scott Sheldon Initiates Change in Consulting Industry
8. First targeted nanomedicine to enter human clinical studies
9. Clinical insight improves treatment with new lung cancer drug
10. Clinical news alert from the American Academy of Orthopaedic Surgeons
11. NYU Langone experts present research, clinical advances at neurosurgeons meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/28/2017)... ... February 28, 2017 , ... ... in North America for the scientific development, healthcare training and clinical application of ... & Scientific Session on September 16-17 in Greenville, SC at the Bon Secours ...
(Date:2/28/2017)... , ... February 28, 2017 , ... ... Inc., a healthcare automation intelligence company based in New York. , “Ensuring an ... the provider’s workflow remains unaltered. Those two fundamental reasons are the reasons this ...
(Date:2/27/2017)... ... February 27, 2017 , ... It’s ... strength, which often leads to a host of health issues, including urinary incontinence. ... Geriatrics Society discovered that good overall muscle strength in older women, particularly ...
(Date:2/27/2017)... ... February 27, 2017 , ... The threat of nuclear warfare ... for a company involved in the underground testing of nuclear weapons. Years later, when ... Expendable Workers of the Cold War Nuclear Testing,” Clayton exposes the critical decisions made ...
(Date:2/27/2017)... ... February 27, 2017 , ... POUGHKEEPSIE, N. Y. – Peer-reviewed guidelines ... despite scientific studies, the Center for Disease Control ( CDC ) and Infectious Diseases ... Kenneth B. Liegner, M.D. has compiled into a single volume a compelling argument that ...
Breaking Medicine News(10 mins):
(Date:2/28/2017)... ... announced the addition of the "Rheumatoid Arthritis Drugs Price Analysis and ... latest research Rheumatoid Arthritis Drugs Price Analysis and Strategies - 2016, provides ... The research answers the following questions: ... attributes? How are they positioned in the Global Rheumatoid Arthritis market? ...
(Date:2/28/2017)... 2017 Medical robots market is projected to ... billion in 2016, growing at a CAGR of 21.1% ... Read the full report: http://www.reportlinker.com/p04730562-summary/view-report.html ... therapy, technological advancements, increase in funding for medical robots ... growing hospital investments are the key factors driving the ...
(Date:2/28/2017)... , Feb. 27, 2017  Summary This ... understand Syngenta and its partnering interests and activities since ... Description The Partnering Deals and Alliance ... partnering activity of one of the world,s leading life ... prepared upon purchase to ensure inclusion of the most ...
Breaking Medicine Technology: