SAN FRANCISCO, March 7 /PRNewswire-FirstCall/ -- Titan Pharmaceuticals Inc., announced today the initiation of a Phase II study of DITPA (3,5-diiodothyropropionic acid) in the treatment of elevated cholesterol levels. This study will evaluate the cholesterol-lowering properties of DITPA administered in combination with standard statin therapy, in individuals who are unable to achieve targeted cholesterol level reductions with statin therapy alone. This investigator sponsored study is being conducted at The Johns Hopkins Medical Institutions in Baltimore, Maryland.
Recent data have indicated that further lowering of target LDL cholesterol level guidelines may be important in reducing the incidence of heart disease and stroke. Accordingly, the National Cholesterol Education Program (NCEP) has recently updated its guidelines to recommend that doctors target lower LDL cholesterol levels in their patients.
Treatment with statins is the mainstay of therapy for people needing to lower their LDL cholesterol. However, many such individuals do not achieve the NCEP recommended goals. More than 40% of all Americans have LDL cholesterol levels above the currently recommended target maximum level of 130 mg/dl, and 13 million Americans have coronary artery disease that could benefit from lipid modification therapy. To achieve LDL cholesterol goals, many of these individuals require additional treatment in combination with their standard statin therapy.
Elevated cholesterol and triglyceride levels are associated with hypothyroidism and reduced thyroid hormone function, indicating an important role of thyroid hormone in maintaining normal cholesterol levels. While thyroid hormone treatment has been shown to be effective in lowering cholesterol levels in hypothyroid patients, thyroid hormone itself is generally not suitable for chronic use in people with elevated cholesterol levels, because it has the potential to increase heart rate and overall metabolism.
DITPA is a novel analogue of thyroid hormone, which in early human testing has shown the ability to reduce LDL cholesterol and triglyceride levels. Preclinical and preliminary clinical testing has shown that DITPA has reduced potential for increasing heart rate and metabolism, and it was selected for further development based upon these properties.
In a preliminary Phase II clinical study in 22 patients with congestive heart failure, DITPA was well tolerated and demonstrated the ability to lower total cholesterol, LDL cholesterol, and triglyceride levels. In this study, after four weeks of treatment, DITPA lowered LDL cholesterol levels by 24% and triglyceride levels by 35%. These data provide preliminary evidence of safety, and rationale for further testing of DITPA in individuals with elevated cholesterol levels.
“Mounting evidence suggests that thyroid hormone analogues, such as DITPA, can harness the cholesterol lowering properties of naturally occurring thyroid hormones, but with a potentially improved safety profile,” stated Paul W. Ladenson, M.D., Professor and Director, Division of Endocrinology and Metabolism, The Johns Hopkins Medical Institutions, and a lead investigator of the study.
This Phase II, randomized, double-blind, placebo-controlled study will evaluate DITPA in 60 individuals receiving standard lipid-lowering therapy, whose LDL cholesterol levels are above NCEP guidelines. The study will have 3 treatment groups, and individuals will receive one of two doses of DITPA, or placebo, for 12 weeks. The primary objective of the study is to evaluate DITPA as a cholesterol lowering agent in combination with standard therapy in patients with LDL cholesterol levels greater than the NCEP goals. Secondary objectives include evaluating the effect of DITPA on other lipid targets such as total cholesterol and triglyceride levels, and weight and waist circumference.
“We are pleased to initiate this clinical study of DITPA in the treatment of elevated cholesterol levels,” stated Dr. Louis R. Bucalo, Chairman, President and CEO of Titan.
DITPA is also currently being evaluated in two randomized, double-blind, placebo-controlled Phase II studies in patients with congestive heart failure. In one study, Titan is evaluating DITPA in New York Hospital Association (NYHA) Class III and IV CHF patients with low T3 levels. The second study is sponsored by the Department of Veterans Affairs Cooperative Studies Program and funded by a $3.8 million grant, and is evaluating DITPA in NYHA Class II, III and IV CHF patients.
About Titan Pharmaceuticals
Titan Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of novel treatments for central nervous system disorders, cardiovascular disease, bone disease and other disorders. Titan’s products in development utilize novel technologies that have the potential to significantly improve the treatment of these diseases. Titan also establishes partnerships with government institutions and other leading pharmaceutical development companies. For more information, please visit the Company’s website at http://www.titanpharm.com
The press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company’s development program and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company’s drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug candidates that could slow or prevent product development or commercialization, the uncertainty of patent protection for the Company’s intellectual property or trade secrets and the Company’s ability to obtain additional financing if necessary. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release.
Titan Pharmaceuticals Inc.
CONTACT: Company: Robert Farrell, Executive Vice President & CFO of TitanPharmaceuticals Inc., +1-650-244-4990; Media/Investors: Jonathan Fassbergof The Trout Group for Titan Pharmaceuticals Inc., +1-212-477-9007
Web site: http://www.titanpharm.com/
