Cypros Pharmaceutical reports positive interim results in its Phase II clinical trial of CPC-111 in coronary artery bypass surgery patients.

CARLSBAD, Calif.--(BUSINESS WIRE)--Dec. 13, 1995--Cypros Pharmaceutical Corp. (NASDAQ: CYPR) Wednesday announced preliminary results from the first dose group of its Phase II clinical trial evaluating the effect of CPC-111 in coronary artery bypass grafting (CABG) patients.

The randomized, double-blind, placebo-controlled study showed that the CPC-111 treated patient group had lower (more normal) pulmonary artery wedge pressures and lower serum creatine kinase levels (an enzyme marker of heart cell death).

These differences were both statistically significant. This first-dose-group was composed of 10 placebo and 10 drug-treated patients where drug treatment was given before the surgery. The study is being continued with additional dosing regimens where the drug will be infused both before and during surgery. The company is conducting an analyst teleconference concerning this release at 1:00 p.m., Eastern time, on Thursday, Dec. 14.

Interested analysts and other parties can access the teleconference by dialing 800-633-8409 at 12:50 p.m., Eastern time, on that date and asking to be connected to the "Cypros Analyst Conference".

Anthony W. Fox, M.D., Ph.D., vice president of Drug Development and Regulatory Affairs, commented: "This is the first clinical data on CPC-111 in CABG patients and they obviously must be confirmed; however, they are consistent with our contention that CPC-111 can reduce the injury to ischemic heart muscle and be cytoprotective.

"It is also encouraging that CPC-111 was well tolerated in these patients. We shall proceed to further investigate this effect as well as continue our two other Phase II studies of CPC-111 in different ischemic indications."

CPC-111 (a naturally occurring substance) is one of two proprietary cytoprotective drug technologies in Phase II clinical trials at Cypros. These two therapeutic approaches (CPC-111 and CPC-211) stimulate cellular energy metabolism during episodes of oxygen deprivation. Both drugs represent broad enabling technologies which can potentially benefit many other acute ischemic conditions.

Paul J. Marangos, Ph.D., chairman and chief executive officer, further commented: "We are currently conducting three Phase II trials on CPC-111 and two Phase II trials on CPC-211 (our brain ischemia drug). We are please that this first reported data has demonstrated a beneficial effect of CPC-111 on ischemic myocardium, however, we stress that further studies will be necessary to substantiate this effect.

"Our results are consistent with previous physician-sponsored, published clinical studies showing beneficial effects of CPC-111 in ischemic myocardium."

Cypros Pharmaceutical develops and markets acute-care, hospital-based products. The company's pre-clinical and clinical development programs focus on cytoprotective drugs designed to reduce ischemia (low blood flow) induced tissue damage in acute care settings.

The company has three pre-clinical research and two clinical research programs. Five Phase II trials are currently in progress, which include three for CPC-111 (coronary artery bypass grafting surgery, congestive heart failure and sickle cell anemia crises), and two for CPC-211 (in stroke and head injury patients). The company also markets two intravenous agents (Inulin and Glofil) used to assess kidney function.

CONTACT: Cypros Pharmaceutical Corp.

David W. Nassif, 619/929-9500