heres the news release
Company Press Release
Cypros Pharmaceutical Granted European Approval to
Launch Clinical Trial of Cordox On Heart Transplant
Patients
CARLSBAD, Calif.--(BW HealthWire)--May 27, 1998--Cypros Pharmaceutical Corp.
(AMEX:CYP - news) announced today receipt of European regulatory approval to move forward
with a Phase II clinical study of Cordox(TM) in heart transplant patients.
The 40-patient, placebo-controlled, double-blind study will employ both treatment of the donor
heart and the patient receiving the heart with Cordox. The trial is designed to evaluate the
cardioprotective effects of Cordox prior to and during the transplantation period at a dose level
that showed efficacy in the company's coronary artery bypass grafting clinical trial. The study will
be conducted at the Harefield Hospital in the United Kingdom, one of the largest heart transplant
centers in the world.
Commenting on the clinical study, Dr. Paul J. Marangos, chairman and chief executive officer of
Cypros, stated, ''Heart transplant is a classic ischemic injury, sharing much of the same
pathophysiology with other forms of heart bypass surgery. The information obtained in our
coronary artery bypass grafting surgery trial suggests that Cordox will benefit these patients. This
orphan indication may also represent a more cost effective route for Cordox approval in an
ischemic disorder.''
The effects of Cordox on ischemia-reperfusion injury and inflammation constitute the basis for the
current trial which will evaluate the drug's ability to reduce ischemia-induced complications and the
incidence of early graft dysfunction, as well as improve the tolerable ex-vivo ischemic time for the
donor heart. The Cordox dose regimen for the current clinical trial is based on the coronary artery
bypass grafting trial recently completed by the company which showed a significant
cardioprotective benefit associated with Cordox.
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(R); is preparing to launch
two proprietary, extended-release wound-care products; and, is developing its two lead drugs,
Cordox(TM) and Ceresine(TM), for a variety of ischemic 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, 1997, and the Risk Factors section of the company's
Registration Statement No. 333-25661.
Contact:
Cypros Pharmaceutical Corp.
Paul J. Marangos, 760/929-9500
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