CytoTherapeutics Reports On Status Of Clinical Trials

LINCOLN, R.I., Jan. 15 /PRNewswire/ -- CytoTherapeutics, Inc. (Nasdaq:CTII) and Astra AB of Sweden announced today that they have completed patient enrollment in the Phase IIA clinical trial of CytoTherapeutics' cell- containing, pain-control implant. The Phase IIA trial was conducted at four clinical sites in the United States and Europe.

A total of 17 patients were enrolled in the Phase IIA trial. Fourteen patients have completed the 10-week trial and have had their implants removed.

"We have experienced some difficulty in properly anchoring the implant tether, which resulted in breakage of the active portion of three implants. Minor modifications to the implantation procedure and tether are being implemented to improve proper device positioning and anchoring," stated Richard M. Rose, MD, President and Chief Executive Officer of CytoTherapeutics.

"The FDA has informed us that it has sufficient patient retrieval data on which to base a decision as to future US clinical trials of our pain control device. As with development of any surgical treatment, we expected, based on clinical experience, to modify our procedure to enhance our pain product's ease-of-use and retrievability. We will implement minor modifications to the implant procedure prior to enrolling additional patients in our Phase IIB trial for cancer pain currently underway in Europe. However, we do not anticipate that these changes will significantly delay our overall timeline for completion of that trial," Rose added.

Carl-Johan Dalsgaard, MD, PhD, President of Astra Pain Control AB, said, "Upon completion of these modifications to the surgical procedure, we will move forward with our Phase IIB trial for cancer pain in Europe. Based on our expertise in the field of pain management and with this technology, we are committed to the development of CytoTherapeutics' technology."

The encapsulated-cell, pain-control implant contains bovine adrenal cells which secrete naturally occurring analgesics, such as catecholamines and opioid peptides. The implant is designed to continuously produce these analgesic substances which disrupt the transmission of pain signals to the brain. The implants utilized in the Phase II trials measure approximately seven centimeters in length and approximately one millimeter in diameter and are implanted in the fluid-filled space at the base of the spinal cord via a minimally invasive surgical procedure.

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Headquartered in Sodertalje, Sweden, Astra is a leading international pharmaceutical company focused on developing treatments for respiratory, gastrointestinal and cardiovascular diseases and pain control. Its Astra Pain Control division currently markets a number of local and regional anesthesia products, including Xylocaine, Marcaine and Naropin. Astra's worldwide revenues in 1996 totaled $5.7 billion.

CytoTherapeutics, Inc. is a leader in the development of cell-based therapeutics. The Company's encapsulated-cell technology is designed to treat a number of serious diseases and disorders of the central nervous system (CNS), including chronic pain, by delivering therapeutic proteins directly to the CNS. The Company's stem cell programs seek to repair or repopulate neural or other tissue that has been damaged or lost as a result of disease or injury. For additional information, visit the Company's Internet web site at http://www.cyto.com.

Statements in this press release other than statements of historical facts constitute forward looking comments regarding, among other things, clinical trial strategies and timing, product development plans, regulatory requirements and future business operations. The Company's actual results may vary materially from those forward looking statements due to risks and uncertainties to which the Company is subject, such as uncertainties regarding clinical trial outcomes, failure to achieve required product development, delays in obtaining, or failure to satisfy conditions imposed for, regulatory approval, the need to raise additional capital, risks of third-party intellectual property, adverse clinical developments, and other risks, which are described in Exhibit 99 to the Company's Annual Report on Form 1O-K entitled "Cautionary Factors Relevant to Forward Looking Statements."

SOURCE: CytoTherapeutics, Inc.