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Kosan Initiates Phase 2 Trial Of Alvespimycin, Second-Generation Hsp90 Inhibitor, In HER2-Positive Metastatic Breast Cancer
Kosan Biosciences
Incorporated (Nasdaq: KOSN) announced the initiation of a Phase 2
trial of alvespimycin, the company's second-generation Hsp90 inhibitor, in
patients with HER2-positive metastatic breast cancer. Alvespimycin has
demonstrated the potential to disrupt the activity of multiple oncogenes
and cell signaling pathways implicated in tumor growth, including HER2, a
key signaling pathway in breast cancer. The objective of the Phase 2 trial
is to evaluate the safety and anticancer activity of alvespimycin as a
single agent in patients who have not previously received Herceptin for
metastatic disease except in an adjuvant setting. Antitumor data in
patients with advanced HER2-positive cancer presented at the September 2007
American Society of Oncology (ASCO) Breast Cancer Symposium demonstrated
encouraging antitumor activity of alvespimycin in combination with
trastuzumab (Herceptin(R)).
"HER2-positive metastatic breast cancer represents a major market
opportunity for Kosan that we intend to pursue," said Robert G. Johnson,
Jr., M.D., Ph.D., Kosan's President and Chief Executive Officer. "We
believe that emerging safety and efficacy data from our clinical trials in
this indication with both of our Hsp90 inhibitors and the demonstrated
activity in refractory disease represent a meaningful therapeutic
opportunity. We believe that characterization of the single-agent activity
of an Hsp90 inhibitor in HER2-positive metastatic breast cancer will
provide valuable information to support the design of later-stage trials."
Alvespimycin Phase 2 Development Plan
The single-agent trial of alvespimycin will be conducted in Eastern
Europe and will recruit up to 30 patients in a two-stage trial design.
Patients with HER2-positive metastatic disease and no prior trastuzumab
treatment except as adjuvant therapy (with the last dose more than 12
months prior to study entry) are eligible to participate in the trial.
Alvespimycin will be administered intravenously on a one-hour weekly
infusion schedule of 80 mg/m2 for three weeks out of four weeks in repeated
cycles.
Kosan is also testing alvespimycin delivered orally in a Phase 1 dose
escalation trial exploring different schedules.
Promising Antitumor Activity Shown in Phase 1
In September, at the 2007 ASCO Breast Cancer Symposium, Kosan reported
that alvespimycin demonstrated promising antitumor activity and
tolerability in combination with trastuzumab in a Phase 1 trial of patients
with refractory HER2-positive metastatic breast cancer, and in patients
with refractory ovarian cancer who were progressing on standard
chemotherapy. Of the 27 heavily-pretreated patients enrolled in the Phase 1
trial, 24 patients had HER2-positive metastatic breast cancer and 3
patients had ovarian cancer (HER2 status unknown). Clinical benefit was
observed in 42% of patients (8 of 19 evaluable) with HER2-positive
metastatic breast cancer. Of the 3 patients with ovarian cancer, 1 patient
(13 prior regimens) who was on study for more than 16 months had a near
complete resolution of ascites and left pleural effusion, and an 83%
decrease in CA125. Toxicities in this Phase 1 trial were mainly Grade 1 and
2 (diarrhea, fatigue, headache, arthralgia, nausea) with 80 mg/m2
established as the recommended Phase 2 dose for weekly intravenous
administration. Kosan is currently enrolling a Phase 1 trial to investigate
alvespimycin plus trastuzumab and paclitaxel to establish the initial
safety profile and pharmacokinetics of this triplet regimen and to lay the
groundwork for a potential larger Phase 2/3 trial.
About Kosan
Kosan Biosciences is a biotechnology company advancing two new classes
of anticancer agents through clinical development -- Hsp90 (heat shock
protein 90) inhibitors and epothilones. Kosan is leveraging its proprietary
discovery platform to generate a pipeline of potentially significant
product candidates, primarily in the area of oncology.
Hsp90 inhibitors have a novel mechanism of action targeting multiple
pathways involved in cancer cell growth and survival. Tanespimycin
(KOS-953) is being tested in combination with bortezomib (Velcade(R)) in
patients with multiple myeloma in a registration program called TIME.
Tanespimycin is also being studied in a Phase 2 trial in HER2-positive
metastatic breast cancer in combination with trastuzumab (Herceptin(R)),
and as monotherapy in metastatic melanoma. Kosan's second-generation Hsp90
inhibitor, alvespimycin (KOS-1022), is being evaluated in a Phase 1 trial
in solid tumors in combination with trastuzumab and paclitaxel (Taxol(R))
and in a Phase 2 trial as monotherapy in HER2-positive metastatic breast
cancer (intravenous) and in a Phase 1 trial in solid tumors (oral).
Epothilones inhibit cell division with a mechanism of action similar to
taxanes, one of the most successful classes of anti-tumor agents. KOS-1584
is in Phase 1 clinical trials in patients with solid tumors.
Kosan's motilin agonist compound, KOS-2187, licensed to Pfizer, is in a
Phase 1 safety trial, with plans to pursue development in gastroesophageal
reflux disease (GERD).
For additional information on Kosan Biosciences, please visit the
company's website at http://www.kosan.com.
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 design or
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 Herceptin; Taxol; Velcade.
Kosan iniþiazã Faza 2 proces al Alvespimycin, a doua generaþie Hsp90 inhibitor, În HER2-pozitiv metastatic cancer de sân - Kosan Initiates Phase 2 Trial Of Alvespimycin, Second-Generation Hsp90 Inhibitor, In HER2-Positive Metastatic Breast Cancer - articole medicale engleza - startsanatate