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Kosan Opens TIME 1 Pivotal Phase 3 Trial In Multiple Myeloma
Kosan Biosciences
Incorporated (Nasdaq: KOSN) announced that the Tanespimycin in
Myeloma Evaluation or TIME-1 pivotal Phase 3 trial for tanespimycin as a
potential treatment for multiple myeloma is open for enrollment. TIME-1 is
a pivotal Phase 3 trial comparing tanespimycin in combination with
bortezomib (Velcade(R)) with bortezomib alone in patients following a
single prior course of treatment (first-relapse). Kosan has completed both
a Special Protocol Assessment with the U.S. Food and Drug Administration
and a Scientific Advice process with the Committee for Medicinal Products
for Human Use of the centralized European Medicines Agency, thus, providing
what the company believes is a validated path to registration in many major
world markets for the TIME-1 trial. TIME-1 is the most advanced Hsp90
inhibitor clinical program in the industry, underscoring the company's
leadership in this new class of anticancer therapies.
The TIME registration program is designed to include two trials: a
pivotal Phase 3 trial (TIME-1) and a smaller supportive trial. The TIME-1
trial is proceeding on track and remains the foundation of the company's
registration strategy. The TIME-2 trial, recently opened for patients who
have failed numerous (at least three) prior myeloma therapies, will be
closed and replaced with an alternative supportive trial. TIME-2 had been
designed to support TIME-1 for full approval as well as to provide a
potential strategy for pursuing accelerated approval based on a
demonstration of clinically important activity in highly
relapsed-refractory patients who have no other proven therapeutic options.
Based on accumulating clinical data, Kosan believes that this highly
relapsed-refractory patient population represents an increasingly difficult
efficacy hurdle, and that adjusting the design of the supportive trial to
include a less heavily pretreated patient population that is more likely to
respond will increase the probability of clinical success in the TIME
program. Kosan is confident that an alternative supportive trial can be
completed within the timeframe of the TIME-1 trial and will not affect the
timeline for conclusion of the TIME registration program.
"The opening of our TIME-1 pivotal trial is a major milestone for Kosan
as tanespimycin represents a potentially important new treatment option for
patients with multiple myeloma," said Robert G. Johnson, Jr., M.D., Ph.D.,
Kosan's President and Chief Executive Officer. "We are confident that by
making this adjustment now in our TIME program, we will accomplish three
major objectives: with a different supportive trial design, we will make
TIME a better and stronger registration program; we will preserve a
reasonable and timely pathway to regulatory approval; and, by focusing on
patients with less advanced disease who have been less heavily pretreated,
we will increase the probability of success in our new supportive TIME
trial. The successful completion of TIME-1 remains the foundation of our
registration strategy."
TIME Registration Program
The TIME-1 trial is an open-label, randomized, multi-center,
international trial that will enroll approximately 470 patients with
first-relapse disease. The trial will compare two groups: patients treated
with bortezomib plus tanespimycin and patients treated with bortezomib
alone. Tanespimycin will be administered in a one-hour infusion twice
weekly every three weeks at a dose of 340 mg/m2 and all patients will
receive standard doses of bortezomib (1.3 mg/m2). The TIME clinical program
will utilize Kosan's improved, proprietary, injectable suspension
formulation of tanespimycin. TIME-1 is designed with a primary endpoint of
progression-free survival (PFS), and there are several predefined secondary
endpoints. TIME-1 is powered to show a 2.75 month PFS benefit in the
tanespimycin plus bortezomib group compared to the bortezomib alone group.
The TIME-2 supportive trial, that was originally designed to enroll
approximately 130 patients, will be closed and replaced with a new
supportive trial in patients with less advanced disease.
Kosan's Hsp90 and Epothilone Clinical Programs on Track for 2008
Kosan's TIME registration program is the company's most advanced
program in its clinical portfolio and tanespimycin is the most advanced
Hsp90 inhibitor in clinical development. Tanespimycin has demonstrated high
tolerability and antitumor activity in patients with multiple myeloma as
monotherapy and in combination with Velcade. Data from an ongoing Phase 1b
trial suggest that the combination with Velcade has greater activity in
patients who have received fewer prior regimens than those who were more
heavily pretreated. A recent analysis of the Phase 1b data comparing
patients who had three or fewer prior regimens with patients who received
four or more prior regimens supports the conclusion that less heavily
pretreated patients were more likely to demonstrate an objective response
than patients with four or more prior regimens. The data showed that 60% of
the patients with three or fewer prior regimens had objective responses
while only 22% of the patients with four or more prior regimens had a
response. Data from the Phase 1b trial also suggest that the combination
may exert a neuroprotective effect.
In addition to the activity and tolerability of the tanespimycin
combination in multiple myeloma, tanespimycin has also demonstrated potent
antitumor activity and a high level of tolerability in patients with
HER2-positive metastatic breast cancer. Data from an ongoing Phase 2 trial
of tanespimycin plus trastuzumab (Herceptin(R)) were recently presented at
the 2007 San Antonio Breast Cancer Symposium showing a 55% clinical benefit
in patients who had failed trastuzumab therapy prior to entering the trial.
Kosan's second-generation Hsp90 inhibitor, alvespimycin, has
demonstrated encouraging antitumor activity (42% clinical benefit) and
tolerability combined with trastuzumab in a Phase 1 clinical trial in
patients with refractory HER2-positive metastatic breast cancer, and in
patients with refractory ovarian cancer who were progressing on standard
chemotherapy (presented at the 2007 American Society of Clinical Oncology
(ASCO) Breast Cancer Symposium). Kosan has expanded this Phase 1 trial to
include the combination of alvespimycin plus trastuzumab and paclitaxel
(Taxol(R)). In the first quarter 2008, Kosan plans to initiate a Phase 2
trial of alvespimycin as monotherapy in patients with HER2-positive
metastatic breast cancer who have not previously been treated with
trastuzumab.
Kosan's lead epothilone clinical candidate, KOS-1584, has demonstrated
promising antitumor activity and tolerability in patients with solid
tumors, including non-small cell lung, ovarian and pancreatic cancers.
Kosan plans to initiate a Phase 2 trial of KOS-1584 in non-small cell lung
cancer in the first quarter of 2008.
In addition to its lead programs in Hsp90 inhibition and epothilones,
Kosan's motilin agonist, KOS-2187, licensed to Pfizer, is progressing in a
Phase 1 trial as a potential treatment for gastroesophageal reflux disease
(GERD) and other gastrointestinal disorders. In 2008, Kosan plans to file
investigational new drug (IND) applications for its next-generation
epothilone, KOS-1803, and its novel nuclear export inhibitor, KOS-2464.
This press release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995 (the "Act"). Such forward-looking statements
include but are not limited to statements regarding the further development
and potential safety, efficacy, regulatory status, commercialization and
other characteristics of Kosan's product candidates; and the opening or
initiation of additional clinical trials and the timing thereof. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements. There are a
number of important factors that could cause the results of Kosan to differ
materially from those indicated by these forward-looking statements,
including, among others, risks related to the development of Kosan's
product candidates, including the risk that studies may not accrue patients
on a timely basis, demonstrate safety and efficacy sufficient to initiate
clinical trials, continue clinical development, obtain the requisite
regulatory approvals or to result in a marketable product; the costs of
conducting preclinical and clinical studies for Kosan's product candidates;
Kosan's ability to obtain valid and enforceable patents covering its
product candidates; Kosan's dependence on its collaboration with Pfizer for
development of its motilin agonist product candidate; Kosan's dependence
upon the formation and sustainability of partnering arrangements and other
risks detailed from time to time in the Kosan's SEC reports, including its
Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and
other periodic filings with the SEC. Kosan does not undertake any
obligation to update forward-looking statements.
Velcade(R) (bortezomib) is a registered trademark of Millennium
Pharmaceuticals, Inc.
Herceptin(R) (trastuzumab) is a registered trademark of Genentech, Inc.
Taxol(R) (paclitaxel) is a registered trademark of Bristol-Myers Squibb
Company
Kosan Biosciences Incorporated
http://www.kosan.com
View drug information on Velcade.
Kosan Deschide ora 1 pivot de fazã 3 proces în mielomul multiplu - Kosan Opens TIME 1 Pivotal Phase 3 Trial In Multiple Myeloma - articole medicale engleza - startsanatate