BURLINGAME, Calif., Jan. 31 /PRNewswire/ -- Angiogenix today announced results from the recently completed Phase II clinical trial for ACCLAIM(R), its product candidate for the prevention of nitrate tolerance in chronic stable angina patients. Results demonstrated that ACCLAIM is safe and well tolerated. ACCLAIM, the first proprietary oral nitrate therapy in over a decade, did not meet its primary endpoint of increased treadmill walking time (TWT) with statistical significance. However, the analysis of the data revealed positive, non-statistically significant trends for patients treated with ACCLAIM with regards to time to onset of angina and ST-segment depression. Also, there was a trend towards benefit in those patients receiving concomitant ACE inhibitor therapy.
Patients in the study were randomized to receive either ACCLAIM, a proprietary combination of isosorbide mononitrate plus L-arginine, or conventional standard of care -- nitrate alone therapy. Both groups were tested against the primary endpoint of TWT until moderate angina occurred. Secondary endpoints included time to ST-segment depression and time to first onset of angina. Other endpoints included the need for rescue medication and number of anginal episodes.
"Although each and every endpoint was not fully met, this study confirmed that nitrate tolerance is a significant unmet medical need. Angiogenix continues to believe ACCLAIM has potential for solving this important problem, thus providing significant benefits for angina patients," said Ed Jennings, chief executive officer at Angiogenix. "We will use these data as we design our next study to ensure that the L-arginine plasma concentrations required to prevent tolerance are achieved and maintained."
The ACCLAIM Phase II clinical trial enrolled 204 chronic stable angina patients in a randomized, double-blinded, placebo-controlled, multi-center study in seven countries. Preclinical and preliminary Phase II studies demonstrated ACCLAIM's efficacy -- the ability of L-arginine to prevent nitrate tolerance when added to conventional oral nitrate therapy.
Angiogenix has two other products in its clinical pipeline: ANGX-1039, for treatment of peripheral arterial disease (PAD), a disease affecting blood flow in the arteries and ANGX-3227, for treatment of sickle cell disease, an inherited condition that can affect the shape of blood cells and cause blood flow difficulty in small blood vessels. Both are slated to enter Phase II clinical studies during the first half of 2005. Over 10 million U.S. patients suffer from PAD and only two FDA-approved treatments, pentoxifylline and cilostazol, are generally used to treat this disease. The Company believes the market opportunity for ANGX-1039 to be in excess of $1 billion. There are over 100,000 U.S. patients suffering from sickle cell disease with only partially effective treatments, representing a well defined and targeted market for ANGX-3227. Both ANGX-3227 and ANGX-1039 have demonstrated a patient benefit and a strong safety profile in pilot studies.
Angiogenix is a product oriented biopharmaceutical company with three products in clinical development for the treatment of vascular disease: ACCLAIM(R) for chronic stable angina and congestive heart failure, ANGX-1039 for peripheral arterial disease, and ANGX-3227 for sickle cell disease. Vascular disease remains one of the most significant causes of mortality in the United States and represents large underserved markets in excess of $3 billion. Angiogenix's three product development programs are all aimed at increasing nitric oxide production for the improvement of vascular function.
Chief Executive Officer
Atkins + Associates
CONTACT: Ed Jennings, Chief Executive Officer of Angiogenix,+1-650-552-0765, email@example.com; or Media, Michael Moore ofAtkins + Associates, +1-858-527-3497, firstname.lastname@example.org, for Angiogenix