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Harmion And MethylGene Initiate Phase One Combination Clinical Trial With MGCD0103 And Taxotere(R) In Patients With Solid Tumors
Pharmion
Corporation (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) announced
the initiation of a Phase One clinical trial evaluating MGCD0103, the
Companies' isotype-selective histone deacetylase inhibitor (HDACi) product
candidate, in combination with Taxotere(R) (docetaxel; Sanofi Aventis) in
patients with solid tumors. Taxotere is an approved chemotherapy agent
marketed for use in breast, lung, prostate, gastric and head and neck
cancer.
In the first portion of the trial, MGCD0103 will be given orally, three
times per week for three weeks in combination with Taxotere, which will be
administered on Day 1 of each three-week cycle to patients with cancer
where treatment with Taxotere is approved or considered standard of care,
or patients who have no available standard of care therapeutic options. Key
objectives for this portion of the study will be threefold: to evaluate the
safety of administering these two agents together; determine the maximum
tolerated dose of MGCD0103 when combined with the two fixed doses of
Taxotere; and to define optimal dosing for the second portion of the trial.
In the second portion of the trial, objectives include further assessment
of the safety of the drug combination, quantification of tumor responses
and measurement of the pharmacodynamic and pharmacokinetic characteristics.
The trial may enroll up to 50 patients at cancer centers in North America.
The trial is expected to take 12 to 18 months to complete.
"This is an important step forward in the clinical development of
MGCD0103," said Andrew Allen, executive vice president and chief medical
officer of Pharmion Corporation. "Cytotoxic chemotherapies such as Taxotere
remain the primary therapy for the treatment of most solid tumors, and we
know from preclinical models that MGCD0103 is synergistic with Taxotere and
could potentially sensitize and re-sensitize patients to
microtubule-targeted therapy. Because MGCD0103 is an isotype-selective
HDACi, rather than a broad spectrum HDACi, it targets specific isotypes
likely relevant to cancer, with potential reduction in off-target toxicity.
This may be particularly important as we combine MGCD0103 with cytotoxic
chemotherapy."
"We are delighted to be participating in this trial of docetaxel plus
MGCD0103," commented Dr. Keith Flaherty, Associate Professor of Medicine,
Abramson Cancer Center of the University of Pennsylvania Health System and
a principal investigator for this trial. "MGCD0103 has shown significant
activity in preclinical models, as well as objective responses in ongoing
clinical trials. This clinical study will help build an understanding of
the role of HDAC inhibitors in the treatment of solid tumors for which
docetaxel remains an important standard treatment, an area of great
interest to the research and clinical community."
About MGCD0103
MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor.
Preclinical data suggest that the Class I HDAC isotypes targeted by
MGCD0103 are important in cancer biology and, consequently, such selective
HDAC inhibitors may have increased efficacy and reduced toxicity compared
to non- selective inhibitors. MGCD0103 is being investigated as a single
agent and in combination with other anticancer therapies in the treatment
of a variety of hematological malignancies and solid tumors. MGCD0103 is
currently being studied in clinical trials including Hodgkin's lymphoma,
non-Hodgkin's lymphoma (NHL), myelodysplastic syndromes (MDS), acute
myelogenous leukemia (AML), and pancreatic cancer as either a single agent
or in combination with anticancer therapies.
MGCD0103 has received orphan drug designation from the U.S. Food and
Drug Administration (FDA) and has been designated an orphan medicinal
product by the European Medicines Agency (EMEA) for the treatment of
Hodgkin's lymphoma.
About Pharmion
Pharmion is a leading global oncology company focused on acquiring,
developing and commercializing innovative products for the treatment of
hematology and oncology patients in the U.S., Europe and additional
international markets. Pharmion has a number of products on the market
including the world's first approved epigenetic drug, Vidaza(R), a DNA
demethylating agent. For additional information about Pharmion, please
visit the company's website at http://www.pharmion.com.
About MethylGene
MethylGene Inc. (TSX: MYG) is a publicly-traded biopharmaceutical
company focused on the discovery, development and commercialization of
novel therapeutics for cancer. The Company's lead product, MGCD0103, is an
oral isotype-selective HDAC inhibitor presently in multiple clinical trials
for solid tumors and hematological malignancies, including Phase II
monotherapy and Phase I/II combination trials with Vidaza(R), Gemzar(R) and
Taxotere(R). MGCD265 is an oral kinase inhibitor targeting the c-Met,
Tie-2, Ron and VEGF receptor tyrosine kinases. In addition, MethylGene has
several preclinical programs: MGCD290 an HDAC inhibitor in combination with
azoles for fungal infections; an HDAC program for Huntington's disease; a
sirtuins program for cancer; and a beta-lactamase program to overcome
antibiotic resistance. MethylGene's development and commercialization
partners include Pharmion Corporation, Taiho Pharmaceutical and EnVivo
Pharmaceuticals. Please visit our website at http://www.methylgene.com.
Safe Harbor Statement under the Private Securities Litigation Reform
Act of 1995: This release contains forward-looking statements relating to
the planned development program for MGCD0103, which express the current
beliefs and expectations of management. Such statements are based on
current expectations and involve a number of known and unknown risks and
uncertainties that could cause Pharmion's future results, performance or
achievements to differ significantly from the results, performance or
achievements expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such differences
include, but are not limited to, the potential failure of MGCD0103, to
demonstrate safety and efficacy in clinical and non-clinical testing; the
ability to complete regulatory submissions and gain regulatory approvals in
a timely manner; the ability to initiate and complete trials at the
referenced times; the impact of competition from other products under
development by Pharmion's competitors; the uncertainty of the regulatory
environment and changes in the health policies of various countries;
acceptance and demand for new pharmaceutical products and new therapies;
uncertainties regarding market acceptance of products newly launched,
currently being sold or in development; failure of third-party
manufacturers to produce the product volumes required on a timely basis and
fluctuations in currency exchange rates. Additional risks and uncertainties
relating to Pharmion and its business can be found in the "Risk Factors"
section of Pharmion's Quarterly Report on Form 10-Q for the quarterly
period ended June 30, 2007, its Annual Report on Form 10-K for the year
ended December 31, 2006 and in our other filings with the U.S. Securities
and Exchange Commission. Forward-looking statements speak only as of the
date on which they are made, and Pharmion undertakes no obligation to
update publicly or revise any forward-looking statement, whether as a
result of new information, future developments or otherwise.
Pharmion Corporation
http://www.pharmion.com
View drug information on Taxotere.
Harmion ªi MethylGene Iniþiazã o combinaþie de fazã studiu clinic Cu MGCD0103 ªi Taxotere (R), la pacienþii cu tumori solide - Harmion And MethylGene Initiate Phase One Combination Clinical Trial With MGCD0103 And Taxotere(R) In Patients With Solid Tumors - articole medicale engleza - startsanatate