NEW YORK, LONDON and HAMILTON,
Bermuda, April 22 /PRNewswire/
-- Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") today
announced the initiation of a Phase I/II pediatric dose tolerance
trial to test their investigational new drug XERECEPT® in pediatric
patients suffering from primary, recurrent or metastatic brain
tumors.
Celtic Pharma's objective for this trial is to rapidly
demonstrate the tolerability to increasing doses of XERECEPT® in
pediatric patients. Upon identification of the maximum
tolerated dose, the study will continue to investigate the clinical
benefits of XERECEPT® in this population, particularly with regard
to reduction of dexamethasone dosing requirements and concomitant
clinical benefit to the patients. Dr. Stewart Goldman, medical director of the
Neuro-Oncology unit at Northwestern
University's Feinberg School of Medicine and the study's
Principal Investigator commented, "I am excited to be working on
this very important trial. The effects of dexamethasone
dosing on these children who have brain tumors is heart wrenching
and I look forward to working with Celtic Pharma in the testing of
XERECEPT® in these patients."
Stephen Evans-Freke, co-Managing
General Partner of Celtic Pharma further commented, "The current
standards of care and prognosis for pediatric patients with brain
tumors is very poor and we believe that XERECEPT® may provide a
welcome and needed treatment for these children, in whom the
effects of high-dose steroids are so devastating. We have
been in close contact with leading pediatric neuro-oncologists and
look forward to the completion of this trial. This study is an
important element of our forward development strategy for
XERECEPT®, which we expect to be in registrational trials in the
second half of 2010."
XERECEPT® is an investigational new drug that may present an
alternative to dexamethasone for patients with primary and
metastatic brain tumors. XERECEPT® has shown in Phase II and
Phase III studies that it may provide a safe and effective
alternative to corticosteroid treatment for tumor-related brain
edema and that it may also have direct anti-tumor activity.
Dexamethasone is currently the standard treatment for
peritumoral brain edema, but is associated with debilitating side
effects including diabetes mellitus, hypertension, muscle weakness,
bone loss, impaired wound healing and opportunistic infections.
About Celtic Pharmaceutical Holdings L.P.
Celtic Pharmaceutical Holdings L.P. (Celtic Pharma) is a global
private equity investment firm focused on the biotechnology and
pharmaceutical industries. Celtic Pharma was founded by
Stephen Evans-Freke and John Mayo, CBE and is based in Bermuda, with offices in New York and London. Celtic Pharma has acquired and
invested in late stage pharmaceutical programs and manages these
programs through their development for ultimate sale to established
pharmaceutical companies. Celtic Pharma is fully invested at
this time. Celtic Pharma's aim has been to bridge the gap
between the established pharmaceutical companies' new product
pipeline crisis and the biotech industry's capital drought.
For further information, please visit Celtic Pharma's website
at www.celticpharma.com.
Trial Sites
This trial will accrue patients at Children's Memorial Hospital,
a member of the Lurie Comprehensive Cancer Center at Northwestern University (Stewart Goldman MD – Principal Investigator) and
the Dana Farber Cancer Institute, Harvard
University (Mark Kieran MD
PhD – Principal Investigator). These hospitals have two of
the largest pediatric brain tumor programs in the United States and also have with vast
experience in pediatric Phase I trials.
Forward-Looking Statements
Certain statements in this press release that are not historical
facts, including statements that are preceded by, or followed by,
or that include words such as "may," "expect," "anticipate,"
"believe," or "plan," or similar statements, are forward-looking
statements that involve risks and uncertainties, including risks
relating to the results of the clinical trials for XERECEPT® and
the ability of Celtic Pharma or Neurobiological Technologies, Inc.
(Pink Sheets: NTII) ("NTI") to obtain regulatory approval for
XERECEPT®, as well other risks detailed from time to time in NTI's
Securities and Exchange Commission filings. Copies of these
filings are available from NTI upon request. Actual results may
differ materially from those projected. These forward-looking
statements represent our judgment as of the date of the release.
We disclaim, however, any intent to update these
forward-looking statements.
SOURCE Celtic Pharmaceutical Holdings L.P.