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Pharmion And MethylGene Announce U.S. Orphan Drug Designation Granted For MGCD0103 For The Treatment Of Acute Myelogenous Leukemia
Pharmion
Corporation (Nasdaq: PHRM) and MethylGene Inc. (TSX: MYG) announced
that the U.S. Food and Drug Administration (FDA) has designated the
Companies' histone deacetylase (HDAC) inhibitor, MGCD0103, as an Orphan
Drug for the treatment of acute myelogenous leukemia (AML) in the United
States. Criteria for designation require that the product be intended for
treatment of a condition affecting fewer than 200,000 people in the United
States, and the application must include a rationale for the use of the
drug in the rare disease or condition.
Orphan Drug Designation allows special incentives for sponsors planning
to test a product for use in a rare disease or condition. These incentives
include, tax credits, research and development grant funding, and reduced
filing fees at the time of application for marketing approval. Once
approved, the product may qualify for seven years of marketing exclusivity
in the United States.
About MGCD0103
MGCD0103 is an orally-administered, isotype-selective HDAC inhibitor.
The compound is currently in one Phase I combination clinical trial with
Taxotere(R) for solid tumors, two Phase I/II combination trials with
Vidaza(R) for hematological malignancies and with Gemzar(R) for pancreatic
cancer, and five Phase II clinical trials in hematological malignancies.
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 EMEA for the treatment of Hodgkin lymphoma and acute
myelogenous leukemia.
About Acute Myelogenous Leukemia (AML)
Acute myelogenous leukemia (AML) is a cancer of the blood and bone
marrow that is characterized by the rapid proliferation (growth) of
abnormal white blood cells. These cells are unable to perform their regular
functions and eventually crowd out healthy red and white blood cells.
Leukemia cells can also spread to other parts of the body. People afflicted
with AML are susceptible to increased risk of infections, anemia and
bleeding.
AML is the one of the most common forms of leukemia and occurs most
often in older adults -- the average age being 65. The American Cancer
Society estimates that 13,410 new cases and 8,990 deaths occurred in the
United States in 2007.
Although several risk factors for AML have been identified, the
specific cause of AML remains unclear. AML is a potentially curable
disease; but only a minority of patients are cured with current therapies.
Current treatments for AML include chemotherapy, blood transfusions and
stem cell transplants.
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 and Phase 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's preclinical programs include: MGCD290 an HDAC inhibitor in
combination with azoles for fungal infections and a sirtuins program for
cancer. 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
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 September 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 Gemzar; Taxotere; Vidaza.
Pharmion ºi MethylGene anunte SUA orfan de droguri denumire acordatã pentru MGCD0103 pentru tratament de leucemie mielocitarã acutã - Pharmion And MethylGene Announce U.S. Orphan Drug Designation Granted For MGCD0103 For The Treatment Of Acute Myelogenous Leukemia - articole medicale engleza - startsanatate