Elesclomol Study Shows Significant Improvement in Progression-Free Survival for Chemotherapy-Naive Patients With Metastatic Melanoma
CHICAGO, May 20 /PRNewswire/ -- GlaxoSmithKline and Synta
Pharmaceuticals Corp. (NASDAQ:SNTA) today announced positive Phase II
clinical data for elesclomol (formerly STA-4783), an
investigational agent currently in development for metastatic
melanoma. A retrospective analysis showed that stage IV metastatic
melanoma patients treated with elesclomol and paclitaxel who had
not previously received chemotherapy had a statistically
significant improvement in progression-free survival (PFS) compared
to patients who received paclitaxel alone.(1) These data will be
presented at the 44th Annual Meeting of the American Society of
Clinical Oncology (ASCO) in Chicago. Elesclomol is not yet approved
for any indication in any market.
"The incidence of melanoma has continued to rise in recent years
and there is an undeniable need to identify effective treatments
for patients with metastatic disease," said Paolo Paoletti, M.D.,
Senior Vice President of the Oncology Medicine Development Center
at GSK. "GSK is at the forefront of research to improve the lives
of cancer patients, including those with limited treatment options,
and we are dedicated to conducting ongoing trials in metastatic
melanoma."
"The preliminary clinical data for elesclomol in metastatic
melanoma patients are encouraging and underscore the urgent need
for new treatments," said Eric Jacobson, M.D., Senior Vice
President and Chief Medical Officer, Synta. "These data, combined
with earlier clinical and pre-clinical data we have presented for
elesclomol, support our belief that oxidative stress induction is a
promising new approach to cancer therapy in melanoma and,
potentially, other cancer types."
Metastatic melanoma occurs when melanoma - a cancer that begins
in melanocytes, the cells that make skin pigment, or melanin -
spreads to other parts of the body.(2,3) In the U.S. alone, the
percentage of people who develop melanoma - the deadliest form of
skin cancer - has more than doubled in the past 30 years, and about
60,000 people are diagnosed with melanoma and 8,000 will die from
it in 2008.(4,5,6) Worldwide, approximately 132,000 new diagnoses
are made each year.(7) Currently, there are no approved therapies
that have been shown to improve survival for patients with
metastatic melanoma.(8)
Phase II Trial of Elesclomol and Paclitaxel in Stage IV
Metastatic Melanoma: A Subgroup Analysis By Prior Chemotherapy
(Abstract # 9036) Presentation date/time: May 31, 2008, 2:00 PM -
6:00 PM
This retrospective subgroup analysis of a randomized,
double-blind, active-controlled, Phase II trial in patients with
stage IV metastatic melanoma evaluated the rates of
progression-free survival and overall survival for the combination
of elesclomol and paclitaxel versus paclitaxel alone in patients
who received one prior chemotherapy treatment with those who were
chemotherapy-naive. A total of 81 patients evaluated in this
analysis either received 213 mg/m2 of elesclomol co-infused with 80
mg/m2 paclitaxel or 80 mg/m2 of paclitaxel alone in four-week
cycles (once weekly for three weeks and one week's rest) until
disease progression.(1)
Patients who had not received prior chemotherapy and were given
a combination of elesclomol and paclitaxel (n=24), compared to
patients who were given paclitaxel alone (n=8):
-- Experienced a 69 percent reduction in the risk of progression or death
-- Lived an average of almost six months longer (15.9 months versus 10.0
months)
-- Had a longer median progression-free survival (7.1 months versus 1.8
months; p=0.020).(1)
"Metastatic melanoma is an aggressive disease, and patients
currently have few treatment options," said investigator David
Lawson, M.D., Emory University School of Medicine. "Identifying
novel therapies like elesclomol represent the future of treating
this hard-to-treat disease."
Data for patients on the elesclomol and paclitaxel arm who had
one prior chemotherapy showed a trend toward results similar to
patients who had received no prior chemotherapy; however these data
were not statistically significant. Specifically, after receiving
one prior chemotherapy, the median PFS was 2.8 months for patients
receiving elesclomol and paclitaxel (n=29) versus 1.8 months for
patients on paclitaxel alone (n=20; p=0.552), and OS was 9.0 months
for patients on elesclomol and paclitaxel versus 7.8 months for
patients on paclitaxel alone.(1)
Regardless of prior chemotherapy, the most common adverse events
in the elesclomol plus paclitaxel group included fatigue, alopecia,
constipation, nausea, hypoaesthesia, arthralgia, insomnia, diarrhea
and anemia. The most serious adverse events (Grade 3 or higher) for
the combination arm were similar to those seen in the
paclitaxel-only arm and included neutropenia, back pain, fatigue
and neuropathy.(1)
About Elesclomol
Elesclomol is a novel, injectable, investigational drug
candidate that triggers apoptosis (programmed cell death) in cancer
cells. Cancer cells operate at high levels of reactive oxygen
species, or oxidative stress. Elesclomol is believed to act by
increasing the level of oxidative stress in cancer cells even
further, beyond sustainable levels, inducing apoptosis. This
mechanism of action, called oxidative stress induction, represents
a novel way of selectively targeting and killing cancer
cells.
Elesclomol is being developed under a global collaboration
agreement between Synta Pharmaceuticals and
GlaxoSmithKline.
Ongoing Clinical Trials
GlaxoSmithKline and Synta Pharmaceuticals are currently studying
elesclomol in a global, pivotal Phase III trial called
SYMMETRY(SM). The SYMMETRY study is being conducted at
approximately 150 centers worldwide to determine the efficacy of
elesclomol in combination with paclitaxel for the treatment of
patients with metastatic (Stage IV) melanoma.(9) Elesclomol has
received Fast Track and Orphan Drug designation from the FDA for
metastatic melanoma, and the Phase III SYMMETRY trial has completed
a Special Protocol Assessment process with the FDA. Additional
investigations to evaluate elesclomol as a therapy for other
cancers are currently being planned.(9)
GSK in Oncology
GSK Oncology is dedicated to producing innovations in cancer
that will make profound differences in the lives of patients.
Through GSK's revolutionary 'bench to bedside' approach, we are
transforming the way treatments are discovered and developed,
resulting in one of the most robust pipelines in the oncology
sector. Our worldwide research in oncology includes collaborations
with more than 160 cancer centres. GSK is closing in on cancer from
all sides with a new generation of patient focused cancer
treatments in prevention, supportive care, chemotherapy and
targeted therapies.
About GlaxoSmithKline
GlaxoSmithKline - one of the world's leading research-based
pharmaceutical and healthcare companies - is committed to improving
the quality of human life by enabling people to do more, feel
better, and live longer. For company information, visit
GlaxoSmithKline at www.gsk.com.
About Synta Pharmaceuticals Corp.
Synta Pharmaceuticals Corp. is a biopharmaceutical company
focused on discovering, developing, and commercializing small
molecule drugs to extend and enhance the lives of patients with
severe medical conditions, including cancer and chronic
inflammatory diseases. Synta has a unique chemical compound
library, an integrated discovery engine, and a diverse pipeline of
clinical- and preclinical-stage drug candidates with distinct
mechanisms of action and novel chemical structures. All Synta drug
candidates were invented by Synta scientists using our compound
library and drug discovery capabilities. Synta has a partnership
with GlaxoSmithKline for the joint development and
commercialization of its lead investigational drug candidate,
elesclomol, which is in a global, pivotal Phase III clinical trial
for the treatment of metastatic melanoma. For more information,
please visit www.syntapharma.com.
GlaxoSmithKline Cautionary Statement Regarding Forward-Looking
Statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including
those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially
from those projected. Factors that may affect GSK's operations are
described under 'Risk Factors' in the 'Business Review' in the
company's Annual Report on Form 20-F for 2007.
Synta Pharmaceuticals Corp. Safe Harbor Statement
This media release may contain forward-looking statements about
Synta Pharmaceuticals Corp. Such forward-looking statements can be
identified by the use of forward-looking terminology such as
"will", "would", "should", "expects", "anticipates", "intends",
"plans", "believes", "may", "estimates", "predicts", "projects", or
similar expressions intended to identify forward-looking
statements. Such statements, including statements relating to the
timing and progress of our clinical and preclinical programs,
reflect our current views with respect to future events and are
based on assumptions and subject to risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied by such forward-looking statements, including
those described in "Risk Factors" of our Form 10-K for the year
ended December 31, 2007 as filed with the Securities and Exchange
Commission. Synta undertakes no obligation to publicly update
forward-looking statements, whether because of new information,
future events or otherwise, except as required by law.
Notes to Editors:
To access the latest GSK Oncology media materials, visit
www.gsk.com/media.
GlaxoSmithKline Inquiries:
US Media inquiries: Sarah Alspach 1 215 287 6354
(onsite at ASCO)
Mary Anne Rhyne 1 919 483 2839
UK Media inquiries: Philip Thomson 44 20 8047 5502
Joss Mathieson 44 20 8047 5502
Gwenan White 44 20 8047 5502
European Analyst
/Investor inquiries: Anita Kidgell 44 20 8047 5542
Sally Ferguson 44 20 8047 5543
David Mawdsley 44 20 8047 5564
US Analyst/Investor
inquiries: Frank Murdolo 1 215 751 7002
Tom Curry 1 215 751 5419
Synta Pharmaceuticals Corp. Inquiries:
US Media/Investor
inquiries: Rob Kloppenburg 1 781 541 7125
References:
(1) Gonzalez R, Lawson D, et. Al. Final Poster for Abstract #
9036 - Phase 2 Trial of Elesclomol (Formerly STA-4783) and
Paclitaxel in Stage IV Metastatic Melanoma (MM): Subgroup analysis
by prior chemotherapy. To be presented at the 2008 American Society
of Clinical Oncology annual meeting.
(2) Melanoma Home Page. National Cancer Institute. http://www.cancer.gov/cancertopics/types/melanoma
(March 18, 2008).
(3) Melanoma Signs and Symptoms. University of California San
Francisco Medical Center. http://www.ucsfhealth.org/adult/medical_services/cancer/skin/conditions/Melano
ma/signs.html (March 18, 2008).
(4) What You Need to Know About Melanoma. National Cancer
Institute. September 2002. http://www.cancer.gov/cancertopics/wyntk/melanoma
(March 18, 2008).
(5) Why You Should Know About Melanoma. American Cancer Society.
http://www.cancer.org/downloads/CRI/Why_You_Should_Know_About_Melanoma.pdf
(March 18, 2008).
(6) Cancer Facts & Figures 2008. American Cancer Society.
http://www.cancer.org/downloads/STT/2008CAFFfinalsecured.pdf
(March 18, 2008).
(7) Melanoma FAQ. World Health Organization. http://www.who.int/uv/faq/skincancer/en/index1.html
(April 17, 2008).
(8) Tarhini A, Agarwala S. Cutaneous Melanoma: Available therapy
for metastatic disease. Dermatologic Therapy. 2006;
19:19-25.
(9) United States Securities and Exchange Commission. Synta
Pharmaceuticals Corp. Form 10-K. Annual Report Pursuant to Section
13 or 15(d) of the Securities Exchange Act of 1934. Commission file
number 002-33277. For the fiscal year ended December 31,
2007.
(10) Kirshner J. Elesclomol (formerly STA-4783) induces
apoptosis and enhances the anticancer activity of paclitaxel
through induction of oxidative stress. Poster presented at the
International Conference on Molecular Targets and Cancer
Therapeutics: AACR-NCI-EORTC on October 24, 2007.
Source: GlaxoSmithKline; Synta Pharmaceuticals Corp.
CONTACT: US Media inquiries: Sarah Alspach, (onsite at
ASCO),
+1-215-287-6354, or Mary Anne Rhyne, +1-919-483-2839, both of
GlaxoSmithKline
Web Site: http://www.gsk.com/
http://www.syntapharma.com/
Posted: May 2008
