Gloucester Pharmaceuticals Announces Initiation of
Phase I/II Clinical Trial in Patients with Multiple Myeloma
--in preclinical studies, novel HDAC inhibitor
romidepsin demonstrated synergistic activity when combined
with VELCADE® (bortezomib)
in multiple myeloma cells--
Cambridge, MA
February 6, 2007
Gloucester Pharmaceuticals, Inc., an oncology
focused specialty pharmaceutical company, announced today that the
first patient has been treated in a phase I/II investigator-initiated
clinical study of romidepsin in combination with bortezomib to treat
patients with relapsed/refractory multiple myeloma. The study is
being conducted at the Peter MacCallum Cancer Centre in Melbourne,
Australia.
The investigator, Professor Miles Prince, anticipates enrolling
approximately 25 patients in a phase I/II dose-escalation study.
Patients will receive bortezomib at a fixed standard dosing regimen
and romidepsin at increasing doses in order to establish the most
appropriate dose for each drug in this combination regimen. Once
the appropriate dosage is determined, additional patients will be
treated at that dosing regimen. The endpoints for this trial include
both objective response and safety.
"
We are very excited to be working towards what may become a new
treatment approach for this difficult disease," stated Miles
Prince, M.D., Chair of Clinical Cancer Services at the Peter MacCallum
Cancer Centre and principal investigator of the study. "Romidepsin
appears to be a promising investigational drug and pre-clinical
data indicate that the romidepsin and bortezomib combination is
synergistic. It is our hope that the combination of romidepsin and
bortezomib will prove beneficial to patients and we are pleased
to initiate the first clinical trial of this combination in Australia," he
concluded.
"
The initiation of this clinical trial is an important step in Gloucester's
continued development of romidepsin," commented Mitchell Keegan,
Ph.D., Senior Director of Drug Development at Gloucester. "We
now have ongoing clinical trials in five hematologic and solid tumor
indications, including pivotal registration trials in cutaneous
T-cell lymphoma and peripheral T-cell lymphoma."
About Multiple Myeloma
Multiple Myeloma is a type of blood cancer in which plasma cells
grow, divide and accumulate in the bone marrow, resulting
in the decreased production of normal red and white bloods as
well
as
the decreased production of disease-fighting antibodies. According
to
the Multiple Myeloma Research Foundation, 5-6 new cases of
multiple myeloma per 100,000 persons will occur in the U.S. each
year.
About Romidepsin
Romidepsin is a novel agent in a new class of anti-cancer
drugs known as histone deacetylase inhibitors. The Company
is conducting
a pivotal phase II study of romidepsin for patients with
cutaneous T-cell lymphoma (CTCL) and is initiating a pivotal phase
II
study for patients with peripheral T-cell lymphoma (PTCL).
Romidepsin has received both Fast Track and Orphan Drug
Designation by
the
Food and Drug Administration (FDA), and Orphan Drug Designation
from the European Agency for the Evaluation of Medicinal
Products (EMEA) for CTCL. It has also received Orphan Drug Designation
for PTCL from both the FDA and EMEA. Romidepsin is also
in
clinical trials for a variety of other hematologic malignancies
and solid
tumors including hormone refractory prostate cancer, pancreatic
cancer and multiple myeloma. These trials and others are
being conducted
by the Company or the National Cancer institute (NCI), under
a Cooperative Research and Development Agreement (CRADA)
with the
Company. About Gloucester Pharmaceuticals, Inc.
Gloucester Pharmaceuticals, Inc. is a privately-held, venture-backed
company that develops and commercializes innovative products
for the treatment of cancer patients. Gloucester is headquartered
in Cambridge, MA. For more information on Gloucester and
our clinical
development program visit our website at www.gloucesterpharma.com or call 888-474-2825. |