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AmpliMed Corporation Announces Promising 1-year Survival Data From Phase I/II Study Of Amplimexon(R) In Metastatic Malignant Melanoma
AmpliMed reported one year
survival results from a Phase I/II trial of its lead drug candidate,
Amplimexon(R) (imexon for injection) in combination with dacarbazine in
patients with unresectable stage III or stage IV metastatic malignant
melanoma. Results from the full cohort of patients in both the Phase I and
Phase II shows a 11.7 month overall mean survival for the entire patient
set and a 22 month overall mean survival in the subset of patients with
normal LDH levels. This compares favorably to historical controls of 8
months and 10 months, respectively, for patients treated with dacarbazine
alone.
"The impact on overall survival demonstrated by Amplimexon in these
trials is very promising and supports the need for a larger, randomized
trial," said Ronald Garren, M.D., Chief Executive Officer of AmpliMed.
"Amplimexon could represent a significant advance in the treatment of
melanoma for which there have been no new treatments approved in the last
decade."
Amplimexon is a small molecule drug that increases oxidative stress in
tumor cells leading to mitochondrial damage and apoptosis. In preclinical
in vitro and animal model studies it shows activity against human tumors
including melanoma and is synergistic with alkylating agents including
dacarbazine.
Fifty (50) patients were treated with Amplimexon at MTD (maximum
tolerated dose) during the Phase II portion of the trial, receiving 250
mg/m2 of dacarbazine and 1,000 mg/m2 of Amplimexon for 5 consecutive days
every 3 weeks. Phase II was designed to preliminarily evaluate the efficacy
of the Amplimexon/dacarbazine combination in metastatic malignant melanoma,
in addition to safety. The criteria utilized for efficacy evaluation was
RECIST. A total of 68 patients were enrolled at 13 U.S. centers in the
Phase I and Phase II portions of the study.
Clinical Trial Results. The drug combination of Amplimexon and
dacarbazine was well tolerated, with only 10.8 percent of patients showing
myelosuppression and only 7 patients having serious adverse events likely
related to the study drug. An objective response plus stable disease rate
of 30.9 percent was observed for all treated patients (N = 68). The median
overall survival of all patients was 11.7 months compared to approximately
8 months for dacarbazine treated historical controls. There was a minimum
patient follow up of 1 year.
Subsets of patients having a normal serum LDH or alternatively an
elevated LDH were also analyzed for median overall survival. The median
overall survival of the 31 patients in the Amplimexon/dacarbazine group
with a normal LDH was 22.5 months compared to 10 months for a dacarbazine
monotherapy historical control group having a normal LDH. The median
survival was 4.8 months for patients having an elevated LDH, no different
than the historical control group receiving dacarbazine monotherapy.
"In addition to the positive survival advantage observed for patients
with less advanced disease, I am particularly impressed with the relatively
infrequent side-effects of Amplimexon across the entire set of patients
treated, even when administered with full dose standard chemotherapy," said
Evan M. Hersh, M.D., Chief Medical Officer of AmpliMed Corporation. "We
look forward to evaluating Amplimexon in a larger, confirmatory trial and
are excited by the potential this product candidate may offer to patients
with malignant melanoma the most serious form of skin cancer."
About Metastatic Melanoma
Metastatic melanoma is the most deadly form of skin cancer, afflicting
approximately 8,000 patients per year in the U.S. Based on statistics from
the American Cancer Society, melanoma represents about 5% of all skin
cancers, but causes almost 75% of all skin cancer related deaths. Whereas
localized melanomas are largely curable by surgery, metastatic melanoma has
a poor prognosis and there are few effective treatments. This results in an
average survival time of 6.2 to 7.8 months in large multicenter studies.
Two drugs are FDA-approved to treat metastatic melanoma: the alkylating
agent dacarbazine, and the immunotherapy agent interleukin-2. Dacarbazine
as a single agent has minimal activity and interleukin 2 is not widely used
because of substantial toxicity. There have been no new treatments for
metastatic melanoma approved by the FDA in over 10 years. In studies of
dacarbazine as a single agent to treat malignant melanoma, median overall
survival has ranged from 6-8 months.
About Amplimexon
Amplimexon is AmpliMed's parenteral formulation of imexon. Imexon is a
cyanoaziridine compound which showed tantalizing evidence of activity in
limited studies in lung cancer, melanoma and breast cancer that were
documented in publications in the 1980s. The potential of imexon as a
cancer drug was never fully explored, until 1994, when AmpliMed co-founding
scientists Drs. Evan Hersh, David Alberts, Robert Dorr and William Remers
initiated a program to decipher Amplimexon's novel mechanism of action.
This led to the initiation in 2003 of a Phase I clinical study of the drug
as a stand-alone therapy in late-stage cancer patients. Further preclinical
research revealed that the combined use of Amplimexon and certain other
chemotherapeutics resulted in a significant increase in efficacy compared
to either drug alone. These findings are now being translated into a series
of Phase I/II clinical studies of combination therapy in patients with
various types of cancer.
About AmpliMed Corporation
AmpliMed Corporation was founded in 1989 with the support of the
University of Arizona Technology Development Corporation and is focused on
the clinical development of chemotherapeutic agents for cancer. AmpliMed's
strategy is to develop anti-cancer drugs with novel mechanisms of action
designed to overcome some of the limitations, such as myelosuppression
(suppression of blood cell counts), multi-drug resistance
(treatment-induced resistance to many cancer drugs) and cardiac toxicity,
frequently associated with current cancer therapy. The company's lead
product, Amplimexon (imexon for inj.), is in Phase II clinical trials.
AmpliMed Corporation is based in Tucson, Arizona and is on the Web at
http://www.amplimed.com.
Note that the data represented is this press release is provided as a
snapshot of unaudited data, and thus final results may be marginally
different after all auditing activities are concluded.
AmpliMed, Amplimexon and Amplizone are United States trademarks of
AmpliMed Corporation.
AmpliMed Corporation
http://www.amplimed.com
AmpliMed Corporation Announces promitator de 1 an de supravietuire a datelor din Faza I / II de studiu Din Amplimexon (R) În metastatic melanoma maligne - AmpliMed Corporation Announces Promising 1-year Survival Data From Phase I/II Study Of Amplimexon(R) In Metastatic Malignant Melanoma - articole medicale engleza - startsanatate