- Results demonstrate ganetespib is clinically active in patients
with advanced, relapsed/refractory NSCLC -
- Durable,
objective responses observed -
- Favorable safety profile
key to future plans with ganetespib -
LEXINGTON, Mass.–(BUSINESS WIRE)–Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company
focused on discovering, developing, and commercializing small molecule
drugs to treat severe medical conditions, today announced that
encouraging preliminary results of a Phase 2 trial of ganetespib as a
single agent in non-small cell lung cancer (NSCLC) were presented at the
International Association for the Study of Lung Cancer (IASLC) 11th
Annual Targeted Therapies for the Treatment of Lung Cancer Meeting. The
trial is ongoing; final results are expected later this year.
“The results presented today show that ganetespib, administered as a
single agent, achieved objective, durable responses in patients with
advanced, relapsed/refractory NSCLC”
Ganetespib is a potent inhibitor of heat shock protein 90 (Hsp90) that
is structurally unrelated to earlier Hsp90 inhibitors such as 17-AAG,
and has shown superior activity to these agents in preclinical studies.
Ganetespib is currently being studied in a broad range of clinical
trials both as a single agent and in combination with other anti-cancer
agents.
“The results presented today show that ganetespib, administered as a
single agent, achieved objective, durable responses in patients with
advanced, relapsed/refractory NSCLC,” said Jonathan Goldman, M.D.,
Premiere Oncology, who presented the data. “Patients with this advanced
stage of disease are generally heavily pre-treated and highly
drug-resistant; single-agent responses are rare. It is particularly
encouraging that these responses were achieved with a favorable overall
safety profile. Consistent with the previously reported Phase 1 results,
there has been no evidence of the serious bone marrow toxicities and
neuropathy often seen with chemotherapy, or the liver and ocular
toxicities seen with other Hsp90 inhibitors. The most common adverse
events seen with ganetespib have been generally mild or moderate
diarrhea and fatigue, which have been manageable and reversible with
standard care.”
“Results from this trial clearly demonstrate that ganetespib has
clinical activity,” said Vojo Vukovic, M.D., PhD., Senior Vice President
and Chief Medical Officer, Synta Pharmaceuticals. “This activity is
encouraging, creating a promising path for developing ganetespib for use
as a single-agent in treating certain patient populations. The favorable
safety profile supports our strategy of also developing ganetespib for
use in combination with other anti-cancer agents. The combination
approach is particularly exciting because ganetespib has shown
synergistic anti-cancer activity with a number of widely-used agents,
such as taxanes and certain targeted agents. For combination therapy, a
favorable safety profile, including non-overlapping toxicities with
other agents, is essential. We believe the ganetespib clinical activity
and favorable safety results presented today demonstrate
proof-of-concept in NSCLC, and we are excited to lead the way in
realizing the potential of Hsp90 inhibition to benefit cancer patients.”
Results presented by Dr. Goldman today included an evaluation of
adenocarcinoma patients in the EGFR- and K-Ras wild type cohorts of the
trial. All patients had advanced stage NSCLC, received multiple prior
treatments, and either failed to respond or experienced worsening of
disease. Of 33 evaluable patients, three patients achieved durable,
confirmed, objective responses; all three currently remain on treatment
(1 patient 14 months; 2 patients 6 months). A total of 10 patients
achieved target lesion tumor shrinkage; and a total of 22 patients
achieved target lesion stabilization (20% growth). The most common
treatment-related grade 3 or 4 adverse events in this population were
fatigue (8%), diarrhea (6%), and insomnia (6%). Safety results reported
in this population were consistent with safety results reported for the
prior Phase 1 trials for ganetespib, and with the safety results
observed to date across 15 trials, which have included over 350 patients
treated to date. Dr. Goldman’s presentation is available at: http://www.syntapharma.com/Documents/ganetespib-feb2011-iaslc.pdf.
“The results presented today confirm the potential for Hsp90 inhibition
in treating NSCLC,” said Safi Bahcall, President and CEO Synta
Pharmaceuticals. “The anti-tumor activity and favorable safety we have
seen in NSCLC and in other tumor types suggest that ganetespib has broad
potential, commensurate with the multiple known effects of the Hsp90
mechanism of action and the high interest we are seeing in the oncology
community for sponsoring additional trials and research. We look forward
to advancing this program to the next stage in NSCLC and other cancers.”
About the Phase 2 NSCLC Trial
The Phase 2 NSCLC trial is designed to enroll patients with advanced,
metastatic disease (Stage IIIB and IV) who have failed prior therapy.
Patients are grouped into one of three cohorts based on the genetic
profile of their cancer, and are treated with ganetespib, as a
monotherapy, once-weekly at a dose of 200 mg/m2. Based on
encouraging signs of activity, an amendment announced in September 2010
expanded the trial with two additional patient cohorts, including a
cohort which allows for combination treatment with ganetespib and
docetaxel.
About Ganetespib
Ganetespib (formerly STA-9090) is a potent, synthetic, small-molecule
inhibitor of heat shock protein 90 (Hsp90). Hsp90 is a molecular
chaperone required for the proper folding and activation of many
cancer-promoting proteins, and is recognized as a key facilitator of
cancer cell growth and survival. In preclinical experiments, ganetespib
has shown activity in multiple tumor models both as a single agent and
in combination with certain widely used cancer agents. Ganetespib is
currently being evaluated in a broad range of cancer clinical trials
including trials in non-small cell lung, breast, prostrate, pancreatic,
colorectal, gastric, small cell lung, ocular melanoma, liver, GIST and
hematologic cancers. Ganetespib has shown evidence of clinical and
biological activity and has been well tolerated to date with no evidence
of severe liver, ocular, cardiac or renal toxicity seen with other Hsp90
inhibitors. The most common adverse events seen to date have been
diarrhea and fatigue, which have been manageable and reversible.
Information on clinical trials with STA-9090 can be found at www.clinicaltrials.gov.
About Synta Pharmaceuticals
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 discovery capabilities. For more information, please visit www.syntapharma.com.
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, developments and progress
of our ganetespib (formerly STA-9090) clinical program, 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, 2009 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.
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Article source: http://www.businesswire.com/news/home/20110226005014/en/Synta-Announces-Encouraging-Preliminary-Results-Ganetespib-STA-9090
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