Cypros Pharmaceutical To Launch A Phase III Bypass Surgery Trial For CPC-111.

CARLSBAD, Calif.--(BUSINESS WIRE)--Oct. 1, 1997--

Follows Earlier Decision For Phase III Closed Head Injury Trial For Ceresine

Cypros Pharmaceutical Corp. (NASDAQ:CYPR) Wednesday announced that it has selected coronary artery bypass grafting (CABG) surgery as its first Phase III indication for its cardioprotective drug, CPC-111.

Earlier this year the company decided to proceed to Phase III trials with its neuroprotective drug, Ceresine (CPC-211), in closed head injury.

This decision is based on repeated demonstrations of statistically significant improvements in a wide variety of endpoints observed in CABG patients when treated with the drug, including measures of heart damage and recovery of heart function post-surgery. CPC-111 treated patients also appear to require less care post-surgery. It is further supported by new data from a retrospective analysis of the CABG trial showing statistically significant reductions (up to 40 percent) in pulmonary vascular resistance when drug and placebo treatments are compared. Pulmonary hypertension can be a serious complication in bypass surgery patients and the new data suggests a direct protective effect of the drug on the pulmonary endothelium. The company has now evaluated more than 115 patients in its CABG trial and expects to commence Phase III studies in 1998.

The choice of CABG as a focus for Phase III follows evaluation of the drug in multiple cardiovascular ischemia indications. While the most recently completed, single-dose congestive heart failure trial showed average improvement of 15-20 percent in cardiac index and left ventricular stroke work index (both are measures of heart function), these effects were, in general, less robust than those observed in the CABG trial, largely due to the numerous other cardiovascular drugs these patients were taking. The company is considering whether to further pursue the CHF indication, a decision which will be based on attaining the requisite financial resources.

Commenting on the results, Paul J. Marangos, chief executive officer, said: "The company's stated goal of evaluating CPC-111 in multiple ischemic cardiovascular indications has now been successfully accomplished. CPC-111 has now demonstrated positive effects on numerous efficacy parameters in CABG patients, indices of both heart damage such as CKMB levels and a variety of heart function measures such as cardiac index, left ventricular stroke work index, pulmonary artery wedge pressure and, most recently, pulmonary vascular resistance. This coupled with the reduced care requirements observed in the CPC-111 treated patients, allows us to enter Phase III trials with a substantial confidence level. We are very pleased to be making this transition into Phase III trials with both our CPC-111 and Ceresine (CPC-211) drugs, and we will be making an announcement shortly on our single-dose sickle cell anemia crisis trial. This could constitute a third Phase III trial."

Cypros Pharmaceutical Corp. is engaged in the development and marketing of drug products for the hospital market. The company is pursuing a diversified strategy of marketing approved drugs and developing small molecule therapeutics that protect cells from ischemic injury. Ischemia is the number one cause of death in most developed countries. The company currently has three products on the market, Glofil, Inulin and Ethamolin.

This news release contains forward-looking statements which involve risks and uncertainties. Such statements are subject to certain factors which may cause the company's plans to differ. Factors that may cause such differences include, but are not limited to, the risks discussed in the company's Form 10-K/A for the fiscal year ended July 31, 1996 and the Risk Factors section of the company's Registration Statement No. 333-25661.

CONTACT: Cypros Pharmaceutical Corp.

Paul J. Marangos, 760/929-9500

or

KCSA Contact:

Paul Holm/Robert Giordino, 212/682-6300, Ext. 201/289