ANALIZE MEDICALE DE LABORATOR
Aici gasiti analizele medicale grupate pe categorii precum si detalii generale si specifice pentru categoriile respective.
Selectati o categorie din lista de mai jos:
Solutie antistress!
Construieste poduri :)
Prinde pisica neagra :)
BioNumerik Commences Global Phase III Ovarian Cancer Trial On Novel Anticancer Drug Candidate Known As Karenitecin(R)
BioNumerik Pharmaceuticals, Inc.
announced treatment of the first patient in a global Phase III
clinical trial of BioNumerik's anticancer drug candidate known as
Karenitecin(R) in advanced ovarian cancer patients. BioNumerik is
developing Karenitecin (also known as BNP1350) as an investigational new
anti-tumor drug in the camptothecin class of chemotherapy drugs. Based on
prior studies, BioNumerik believes Karenitecin has the potential for fewer
side-effects, better efficacy, and less susceptibility to drug resistance
mechanisms compared to the currently marketed camptothecin drugs.
The Phase III trial has been designed as a global, randomized,
multi-center open label trial to prospectively evaluate the safety and
efficacy of Karenitecin compared to the chemotherapy drug topotecan (also
known as Hycamtin(R)). Either Karenitecin or topotecan will be given
intravenously daily for 5 consecutive days repeated every 3 weeks to
advanced ovarian cancer patients who have previously been treated with
platinum and taxane chemotherapy drugs but have become resistant to the
platinum/taxane therapy. BioNumerik has received written agreement from the
U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment
(SPA) regarding the clinical trial design and protocol.
Four Phase II clinical trials of intravenously administered Karenitecin
have been completed in the U.S. in patients with advanced ovarian cancer,
metastatic malignant melanoma, advanced non-small cell lung cancer, and
primary brain tumors. BioNumerik has also initiated a Phase I clinical
trial to evaluate the safety and effectiveness of an orally administered
Karenitecin formulation. Based on prior studies, BioNumerik believes
Karenitecin may have the following potential advantages over currently
marketed camptothecins:
-- Comparable or improved effectiveness in the treatment of certain
cancers, with a potentially improved safety profile and fewer of the
dose-limiting side-effects caused by camptothecin drugs including:
- lower incidence of severe diarrhea than that caused by irinotecan
(also known as Camptosar(R));
- lower incidence of anemia and neutropenia (reduction in white blood
cell counts), than that caused by topotecan (also known as
Hycamtin(R));
-- Less susceptibility than currently marketed camptothecins to common
drug resistance mechanisms found in many types of human cancer cells,
including resistance mechanisms that are specific to the camptothecin
class; and
-- Because Karenitecin is lipophilic (fat loving), BioNumerik believes
Karenitecin may have enhanced tissue penetration, drug delivery and
bioavailability compared to existing water soluble camptothecins.
In commenting on these developments, Frederick H. Hausheer, M.D.,
BioNumerik's Chairman & Chief Executive Officer stated: "There is a large
unmet need for 2nd and 3rd -line therapies that can prevent progression of
recurrent or progressive ovarian cancer with reduced risk of cumulative
toxicity in patients who have become resistant to platinum/taxane-based
chemotherapy. Ovarian cancer is difficult to diagnose early and patients
are usually diagnosed with advanced disease (Stage III or IV). Outcomes for
patients with advanced ovarian cancer remain poor. Up to 80% of ovarian
cancer patients who initially respond to treatment will ultimately relapse
and require additional therapy, and treatment options for patients with
advanced recurrent ovarian cancer are limited. In addition, all approved
agents for the treatment of advanced ovarian cancer are associated with
significant toxicity that can be dose-limiting."
Dr. Hausheer added, "We believe the safety and efficacy outcomes from
the previously completed Karenitecin Phase II advanced ovarian cancer trial
compare favorably with the historically reported results of approved
agents. Based on the Phase II outcomes and our pre-clinical data, we are
pursuing Karenitecin Phase III testing in advanced ovarian cancer patients
who have become resistant to platinum/taxane chemotherapy."
About BioNumerik:
BioNumerik Pharmaceuticals, Inc., based in San Antonio, Texas, is
focused on the discovery, development and commercialization of novel drugs
for the treatment of cancer and cancer supportive care. The Company
currently has two drug candidates, Karenitecin(R) and Tavocept(TM), in
late-stage clinical development. BioNumerik has eight additional drug
discovery research programs, and has generated a patent portfolio of more
than 450 patents and pending patent applications worldwide.
BioNumerik Pharmaceuticals, Inc.
http://www.bionumerik.com
BioNumerik începe global de fazã III, cancer ovarian proces roman pe droguri anticanceroase candidat cunoscut ca Karenitecin (R) - BioNumerik Commences Global Phase III Ovarian Cancer Trial On Novel Anticancer Drug Candidate Known As Karenitecin(R) - articole medicale engleza - startsanatate