BioNumerik Pharmaceuticals, Inc.
announced treatment of the first forbearing in a global Phase III
clinical annoyance 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
latest studies, BioNumerik believes Karenitecin has the latent for fewer
side-effects, raise 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 go to prospectively evaluate the safe keeping and
efficacy of Karenitecin compared to the chemotherapy remedy topotecan (also
known as Hycamtin(R)). Either Karenitecin or topotecan command be acknowledged
intravenously daily as a replacement 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 secure become resistant to the
platinum/taxane therapy. BioNumerik has received written accord from the
U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment
(SPA) Dialect anenst despite the clinical trial design and protocol.
Four Phase II clinical trials of intravenously administered Karenitecin
bear been completed in the U.S. in patients with advanced ovarian cancer,
metastatic virulent melanoma, advanced non-midget cell lung cancer, and
foremost understanding 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 own the following aptitude advantages over currently
marketed camptothecins:
– Comparable or improved effectiveness in the treatment of predetermined
cancers, with a potentially improved safety make the most of and fewer of the
dispense-limiting side-effects caused by camptothecin drugs including:
- minuscule frequency of fastidious diarrhea than that caused by irinotecan
(also known as Camptosar(R));
- lower number of anemia and neutropenia (reduction in snowy blood
room counts), than that caused by topotecan (also known as
Hycamtin(R));
– Less susceptibility than currently marketed camptothecins to common
drug guerilla movement mechanisms found in many types of mortal cancer cells,
including resistance mechanisms that are specific to the camptothecin
class; and
— Because Karenitecin is lipophilic (fat loving), BioNumerik believes
Karenitecin may deceive 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 -filament therapies that can retard progression of
reappearing or advanced ovarian cancer with reduced imperil 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 pro
patients with advanced ovarian cancer crumbs poor. Up to 80% of ovarian
cancer patients who initially respond to treatment intent ultimately failure
and require additional therapy, and treatment options for patients with
advanced recurrent ovarian cancer are restricted. In addition, all approved
agents for the treatment of advanced ovarian cancer are associated with
informative toxicity that can be dose-limiting.”
Dr. Hausheer added, “We believe the safety and efficacy outcomes from
the previously completed Karenitecin Insert II advanced ovarian cancer provisional
refer 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 intractable to platinum/taxane chemotherapy.”
All round BioNumerik:
BioNumerik Pharmaceuticals, Inc., based in San Antonio, Texas, is
focused on the discovery, circumstance and commercialization of novel drugs
in regard to the treatment of cancer and cancer helpful tend. The Guests
currently has two antidepressant candidates, Karenitecin(R) and Tavocept(TM), in
behindhand-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 ![]()