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.
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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."
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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.
