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Inventor of the 1st Heart Drug for women

Press Release Excerpts

Functional abnormality in heart disease in women leads to new optimized transdermal strategy

At the One Med Forum Conference in San Francisco on Feb 1, 2010, Dr. R. Kent Hermsmeyer presented human and primate data showing the ability to effectively treat heart disease in women by continuous release (optimized duration-of-action) modulation of gene expression. The news interview conducted at One Med Forum, held in association with the JP Morgan Annual Health Care Conference at the Sir Francis Drake Hotel, is available as a video file (5 min duration).

Heart Disease and Angina Pectoris in Women

At the Boston MA SBIR Assets (by invitation) Forum in Oct 2009, Dr. R. Kent Hermsmeyer presented growing evidence that heart disease in women is predominantly due to microvascular ischemia, and Dimera's rational approach to solving this major unmet need. Different signs and symptoms of ischemic heart disease (IHD) in women, and the association of angina attacks with resting conditions (especially during sleep) contrast with the association in men of angina with exercise. The exercise tests used as standard practice for diagnosis of coronary artery disease, and even the angiographic catheterization studies increasingly used, would not detect the microvascular functional causes that are typical in women. This presentation emphasized the additional approach to treating and preventing angina pectoris and coronary artery problems offered by the new drug, DP9, that is optimized for treatment needed by women with microvascular IHD. For action on expression of the key gene that Dimera hypothesizes may explain the prolonged vasoconstriction of microvessels (too small to visualize by X-ray studies in the cardiac catheterization laboratory), continuous release of the drug is necessary. DP9 is in advanced clinical trial testing, presently ready for FDA Phase III randomized controlled trials to support the filing of the planned New Drug Application that can lead to FDA approval and availability as a the 1st heart drug for women.

Evidence for effective coronary artery treatment in women

Dimera presented key evidence for the novel gene expression mechanism of its lead drug in development, DP9, at the 2009 Invest NorthWest Meeting in Seattle. Dimera has pioneered a strategic approach to heart disease in women based on evidence of overexpression of a blood vessel receptor that produces abnormally prolonged vasoconstriction, and thus ischemic heart disease, and is predominant in women. This new strategy progresses beyond treatment approaches that are effective only against ischemia due to plaques, clots, and other fixed structural occlusions. Treatment for at least 2 weeks with pharmacokinetically optimized DP9 dramatically decreased expression of thromboxan-prostanoid (TP) receptors, the identified molecular mechanism, prolonged coronary vasoconstriction, and angina pectoris symptoms of ischemic myocardium.

Novel Insights for Heart Disease in Women

Portland OR, July 17, 2008 – Heart disease is the leading cause of death and a major cause of disability among women in the United States. Diagnosing and effectively treating heart disease is more difficult in women than men. Four prominent scientists, Drs. Hermsmeyer, Thompson, Pohost, and Kaski, writing in the July issue of Nature Clinical Practice Cardiovascular Medicine, have reported novel insights and called upon the medical community to reconsider and fully explore the benefits of progesterone treatment of menopausal women who suffer from cardiac chest pain and related sleep disturbances.

Until recently, many women used hormone replacement therapy (HRT) to help reduce their risk of heart disease. But when the outcomes of large randomized clinical trials failed to demonstrate cardiac benefits, women and their physicians abandoned HRT. In fact, current medical practice guidelines advise against HRT for the purpose of reducing cardiovascular (CV) risk in post-menopausal women.

Lead author Dr. Kent Hermsmeyer asserts that, “it is important to remember that the hormone replacement therapy rejected by these landmark studies did not involve use of progesterone; in distinction, most HRT involves use of a synthetic progestin called medroxyprogesterone acetate, which does not exhibit the heart protective effects offered by progesterone. Rather than simply rejecting all steroid hormone supplement therapies, it is time to consider what is known and what is not known in the heart research in women reported to date.”

The NIH supported projects leading to this publication were conducted by Dimera in association with Cardiology Consultants in Medford Oregon, the Oregon National Primate Research Center, the Washington National Primate Research Center, and with contributions of respected FAHA authors Gerald M Pohost at the University of Southern California and Juan Carlos Kaski at St George’s Hospital Medical School in London UK.

Dimera investigators correctly predicted that progesterone, a naturally occurring hormone, plays an important role in reducing CV risk in post-menopausal women. They contend that the apparent blanket condemnation of steroid hormones has not sufficiently distinguished between the CV actions of progesterone and the synthetic progestin that was used in HRT.

The article cites the mounting evidence that progesterone improves CV function and proposes that it improves heart health and well being. It also points out that the route of administration is key, and that delivering progesterone in a vanishing cream that is applied to the skin is a safe, effective way to help women reduce CV risk, relieve heart-related chest pain, and consequently improve their likelihood of undisturbed sleep and improved quality of life.

Defined path through Phase III Clinical Trials for DP9, the 1st heart drug for women

Dr. Theresa L. Thompson, Vice-President for Research at Dimera, presented the favorable status of development of DP9, at the March 2008 Invest NorthWest Meeting in Seattle. She contrasted the types of heart disease typical of women with those in men, pointing out evidence for the unmet need for a heart drug designed explicitly for women. Dimera Pilot Clinical Trial data demonstrated that DP9 dramatically decreases the incidence of angina pectoris in a 28-day interval, while apparently not changing the outcome of the treadmill exercise test that is used to diagnose heart disease. The outcome is consistent with the Dimera design hypothesis that coronary hyperreactivity, and not fixed structural obstructions, are typical in women. Angina in women has different symptoms, usually does not depend on exercise, and is often worsened by nitroglycerin and the nitrate vasodilator medications that are effective in men. Dimera investigations have provided extensive data that suggest that DP9 may be effective in women for whom there appears to be no solution.

Molecular Biology insights lead to a new drug, DP9, to directly treat angina pectoris in women

At the June 2007 C-21 Conference in Monterey CA, Dr. R. Kent Hermsmeyer and Dr. Ray Lipicky presented a summary of the rational molecular biological translation of advancing knowledge into development of the new drug, DP9, created to treat and prevent angina pectoris in women.

Discoveries of the etiology of heart disease in women lead to the 1st heart drug designed specifically for women

In October 2006, Dimera presented the successful development and proof of principle in London UK at the Biotechnology Conference. Dr. R. Kent Hermsmeyer and Ms. Amanda E. Durkee showed the path that Dimera has followed in the past decade to innovate a drug that is effective for heart disease in women, solving a top priority unmet need.

Contact: Dr. Theresa L. Thompson
Vice-President of Research
Dimera Incorporated
Phone Number: 503-295-2775
FAX Number: 503-295-2757
Email Address: tlt@dimera.net