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StemCells, Inc. (ticker: STEM, exchange: NASDAQ) News Release - 15-Jun-1998
CytoTherapeutics And Astra Resume Phase IIB Clinical Trial Of Pain Control Implant
LINCOLN, R.I. -- June 15, 1998 -- CytoTherapeutics,
Inc. (Nasdaq:CTII) and Astra AB of Sweden have resumed patient
enrollment in the Phase IIB clinical trial of CytoTherapeutics'
cell-containing, pain-control implant at multiple clinical centers in
Europe. This follows the January 1998 announcement by CytoTherapeutics
that it would implement minor modifications to the surgical procedure
to assure proper anchoring of the implant prior to enrolling
additional patients in the Phase IIB trial. In addition, Astra has
agreed to increase its support to CytoTherapeutics for the pain
program by approximately 20%, up from $7 million to $8.5 million, for
the current year.
"By implementing these modifications to our implant procedure so
quickly, Astra still expects to complete patient enrollment in this
trial by the end of the year," stated Richard M. Rose, MD, President
and Chief Executive Officer of CytoTherapeutics. "Furthermore, based
on that timeframe, Astra could expect to complete its evaluation of
the trial data in the first part of 1999."
"We strongly believe that CytoTherapeutics' technology can
significantly improve pain management for the thousands of patients
who are unable to be treated by other methods," added Carl-Johan
Dalsgaard, MD, PhD, President of Astra Pain Control AB.
According to the Phase IIB trial protocol, approximately 150
cancer patients will be included in the double-blind,
placebo-controlled trial, which is designed to demonstrate efficacy
and safety. Patients participating in the trial will receive an
implant for a 10-week period. Following completion of a 10-week
implantation, patients may elect to receive an additional active
device.
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 IIB trial 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.
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 1997 totaled $5.7 billion.
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