Cypros Pharmaceutical reports results in three Phase II trials; company moves closer to Phase III clinical testing.

CARLSBAD, Calif.--(BUSINESS WIRE)--June 23, 1997--Cypros Pharmaceutical Corp. (NASDAQ:CYPR) Monday announced further results in three of its six double-blind, placebo-controlled, Phase II clinical trials on both CPC-111 and Ceresine (CPC-211).

Additional dose-level testing in the company's CPC-111 bypass surgery trial and Ceresine closed head injury trial continue to support the drugs' safety and efficacy and the feasibility of launching Phase III trials in these indications by year's end. Due to an insufficient level of treatable heart damage, the CPC-111 angioplasty trial results were inconclusive.

The company previously reported that CPC-111 had marked cardiprotective effects in a placebo-controlled, double-blind trial of 50 bypass surgery patients at a single dose of 250 mg/kg. These results included reduced heart damage, better post-operative heart function and a trend towards reduced requirement for intensive care. The data reported Monday were for a single dose of 125 mg/kg given i.v., pre-operatively, in 20 additional patients. The results supported those previously reported, with the drug-treated patients showing improvements in heart function and reduced heart damage, but to a lesser degree than the previously reported 250 mg/kg dose. The company, therefore, intends to use the higher dose in future studies. The company has now enrolled a total of 70 patients in this study and is currently evaluating a multi-dose protocol with the drug given both pre- and post-operative before considering a Phase III protocol.

The company also reported results in its CPC-111 angioplasty trial where the drug was well tolerated, with no significant side effects. Due to an insufficient level of heart damage, the effects of the drug were not evident when treated and placebo patients were compared. These findings are consistent with recently published clinical data on the drug in coronary artery disease patients (American Heart Journal, Vol. 133, pages 541-549, 1997) which shows that the cardiprotective effect of CPC-111 is most apparent in those patients with more severe impairments in heart function.

The company also reported further results in its Ceresine head injury study. In this study, Ceresine doses of 200 mg/kg caused significant reduction in brain lactate. Lactate accumulates in the brain after head injury and high levels correlate with poor outcomes. These results support previously reported results with Ceresine showing similar reductions in brain lactate at 100 mg/kg. The company, therefore, believes it is not necessary to exceed the 100 mg/kg dose to obtain the optimal brain lactate-lowering effects with Ceresine. The company has now evaluated three Ceresine dose levels in head injury patients and will shortly complete a multi-dose protocol before finalizing its Phase III protocol. A total of 30 patients have now been treated in this trial.

Commenting on the results, Paul J. Marangos, chairman and CEO, said, "We are very pleased that our multi-indication clinical trial strategy has been successful in permitting us to make data-based judgments on which indications to pursue in Phase III trials. Thus far, we have treated a total of 256 patients in four CPC-111 Phase II trials and 47 patients in two Ceresine Phase II trials. We are making steady progress in identifying the appropriate ischemic indications for both of our drugs and determining optimal dose regimens. With results reported in three of our six Phase II trials, we now have two feasible Phase III indications with bypass surgery and closed head injury. We have therefore achieved our initial goal of identifying at least one feasible Phase III indication for each drug. Results in our other Phase II trials (sickle cell crisis, congestive heart failure and stroke) are forthcoming and will determine whether additional Phase III trials are justified."

Cypros Pharmaceutical 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. The company currently has three products on the market, Glofil, Inulin and Ethamolin. The company's CPC-111 and Ceresine drugs are currently in Phase II clinical trials for a variety of cardiovascular and neurological disorders.

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 for the fiscal year ended July 31, 1996 and the Risk Factors section of the company's Registration Statement No. 333-17501.

CONTACT: Cypros Pharmaceutical Corp.

David W. Nassif, 760/929-9500

or

KCSA 

Joseph Manzi or Adam Friedman, 212/682-6300