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Jennerex Publishes Clinical Trial Data With Lead Product JX-594 Demonstrating Efficacy Against Liver Cancer And Associated Hepatitis B Virus
Jennerex, Inc. (San Francisco, CA and Ottawa, Ontario), and its South
Korean partner Green Cross Corp., announced that novel findings from
a Phase I clinical trial of its first-in-class lead product JX-594
demonstrated that the product was well-tolerated and resulted in clear
anti-cancer efficacy in patients with liver cancer. Three patients with
advanced treatment-refractory hepatitis B virus (HBV)-associated
hepatocellular carcinoma (HCC) were treated with JX-594. Objective
radiographic responses were demonstrated. Serum tumor markers, which
correlate with tumor burden over time in patients, decreased by up to 95
percent after treatment. JX-594 replication, its release into the
circulation and distant tumor targeting and infection were demonstrated.
JX-594 administration resulted in tumor vascular shutdown. Oncolytic
virotherapy was also shown, for the first time, to suppress underlying HBV
replication in HCC patients by over 50 percent in all three patients. A
Phase II clinical trial is now underway for JX-594 in liver cancer. The
data were published in the journal Molecular Therapy.
"These clinical results with JX-594 in end-stage liver cancer patients
represent a major step forward for JX-594 against this difficult to treat
cancer. We are excited by the potential to fulfill the huge unmet medical
needs for these desperate patients with no curative treatment options,
specifically by treating their tumors and potentially their underlying
Hepatitis B viral infection. As a lead site for the on-going Phase II trial
of JX-594 for liver cancer, we look forward to extending these results in a
larger number of patients," said Dr. Tony Reid, M.D., Ph.D., Associate
Professor and Director of Clinical Investigation at the University of
California, San Diego Moores Cancer Center.
"After years of methodical design and development to optimize our
products, these results in end-stage liver cancer patients clearly validate
our breakthrough product class. The clinical and mechanistic results were
predicted based on extensive lab testing of JX-594. This peer-reviewed
publication in Molecular Therapy represents a major clinical and scientific
advance for JX-594," said David Kirn, M.D., President & CEO of Jennerex.
"As always, we thank the doctors, the patients and their families, and our
partners at Green Cross who have all pioneered this treatment with us."
Phase I-II Liver Cancer Study
As previously reported, 14 patients with a variety of
treatment-refractory cancer types (e.g. liver, colon, lung) in the liver
were treated every three weeks with JX-594 by ultrasound-guided
intratumoral injection. Patients had advanced cancers that had failed all
available therapies and were therefore considered terminal. Treatment was
well-tolerated during dose-escalation up to the maximum-tolerated dose,
with the expected mild to moderate flu-like symptoms; no severe toxicities
due to treatment were reported up to these doses. Cancer destruction and
objective evidence for efficacy were reported in the majority of patients,
including all three with primary liver cancer and patients with lung and
colon cancers. Tumor responses were achieved in evaluable patients by
objective criteria including RECIST (Response Evaluation Criteria in Solid
Tumor) (response in 30 percent of patients, stable disease in 60 percent of
patients) and Choi criteria (response in 80% of patients). Tumor responses
were associated with long-term survival in many patients, including four
who survived for 11 to over 18 months. Mechanism-of-action of JX-594 was
validated in patients by demonstration of tumor-specific replication and
tissue destruction with JX-594, in addition to high-level active expression
of the GM-CSF protein in the blood of patients. These results led to the
initiation of a Phase II liver cancer trial that is now open in the U.S.,
and will shortly begin enrolling patients at sites in South Korea and
Canada, as well.
About JX-594
JX-594 is a cancer biotherapeutic, currently in Phase II trials, from a
proprietary class of targeted and armed oncolytic poxviruses. Tumor
destruction and safety was shown in patients with diverse cancer types in
three Phase I trials; treated patients were end-stage and had no effective
therapies available. JX-594 multiplies selectively within cancer cells,
leading to their destruction. These newly created copies of JX-594 are then
released and are able to infect and eradicate other tumor cells both
locally and in distant sites in the body. This cycle of JX-594 replication,
cancer cell destruction, release and spread is then repeated. Normal cells
are not affected by JX-594 resulting in safety and tolerability. The
poxvirus strain backbone of JX-594 has been used safely in millions of
people as part of a worldwide vaccination program against smallpox. This
strain naturally targets cancer cells due to common genetic defects in
cancer cells. JX-594 was engineered to enhance this natural safety and
cancer-selectivity by deleting its thymidine kinase (TK) gene, thus making
it dependent on the cellular TK expressed at persistently high levels in
cancer cells. To enhance product efficacy, JX-594 is also engineered to
express the GM-CSF protein. GM-CSF complements the cancer cell lysis work
of the product candidate, leading to a cascade of events resulting in tumor
necrosis, tumor vasculature shutdown and an anti-tumoral immune attack.
About Jennerex
Jennerex is a clinical-stage biopharmaceutical company focused on the
development and commercialization of first-in-class, breakthrough targeted
oncolytic products for cancer. The company's lead product JX-594, currently
in an international Phase II trial for primary liver cancer, demonstrated
promising Phase I efficacy and safety results in patients with a diverse
array of common large market cancers. Jennerex's products target, attack
and eradicate cancers through a novel and potent oncolytic mechanism that
is dependent on highly-specific replication of the company's poxviruses in
cancer cells. These products simultaneously stimulate the body's immune
response to the cancer. Of note, this mechanism of action and the results
in patients to date put the company's product class in a leadership
position. Jennerex's position is in marked contrast to gene therapy and
standard cancer vaccine approaches. For more information about Jennerex and
the company's robust pipeline and three clinical-stage products, please
visit http://www.jennerex.com.
About Green Cross Corporation
Green Cross is a leader in the Korean biotechnology and pharmaceutical
industries. Green Cross is now an internationally recognized biotechnology
company developing several vaccines and therapeutic proteins. Green Cross
will become the only seasonal influenza vaccine manufacturer in South Korea
and also is developing avian influenza vaccine. In its vaccine business,
Green Cross has successfully developed one of the earliest vaccines against
Hepatitis B (Hepavax), the first Epidemic Hemorrhagic Fever vaccine and the
world's second chicken pox vaccine. Green Cross is developing anticancer
drugs such as Greenstatin (anti-angiogenic peptide) and modified PEG-G-CSF
for neutropenia.
Jennerex, Inc.
http://www.jennerex.com
Jennerex publicã studiu clinic de date cu plumb Produsul JX-594 Demonstrarea Eficacitatea împotriva Ficat de Cancer ºi asociate virusului hepatitic B - Jennerex Publishes Clinical Trial Data With Lead Product JX-594 Demonstrating Efficacy Against Liver Cancer And Associated Hepatitis B Virus - articole medicale engleza - startsanatate