-Company announces plans to proceed into Phase 3 stage of the GALAXY Trial by year-end-
“This year we made significant progress in the clinical development of
ganetespib, our lead Hsp90 inhibitor, for cancer,” said
“Existing cancer therapies are generally either non-specific or target
one particular signaling protein involved in one or a small number of
cancer signaling pathways,” said Dr.
The GALAXY trial is a Phase 2b/3 trial designed to compare standard-of-care docetaxel with or without ganetespib in a second-line advanced NSCLC treatment setting. The Phase 2b portion of this trial, targeted to enroll 240 patients, is designed to identify one or more patient populations, defined by outcomes of biomarker analysis and other disease characteristics, which are best suited for enrollment in the Phase 3 portion of the trial. An interim analysis for the first-stage, Phase 2b portion is currently in progress, with an announcement planned for later this quarter. Based on encouraging results seen to date, Synta plans to meet with regulatory agencies and advance to the second-stage Phase 3 portion of this trial before the end of the year.
Two clinical trials confirming ganetespib activity in crizotinib-naive
ALK+ advanced NSCLC patients are also initiating: a company-sponsored,
100-patient, Phase 2 monotherapy trial and a Phase 1/2 trial in
combination with crizotinib being conducted by
In addition to NSCLC, ganetespib is also being evaluated as potential
treatment for metastatic breast cancer. Clinical data presented from a
Phase 2 investigator-sponsored trial at the San Antonio Breast Cancer
Synta expects that a number of third-party sponsored trials evaluating
ganetespib will commence or continue in 2012. These include trials in
combination with radiotherapy, a randomized trial in elderly patients
with acute myelogenous leukemia (AML) in combination with cytarabine,
and a Phase 1/2 trial both as a single agent and in combination with
VELCADE® for the treatment of multiple myeloma. The multiple myeloma
trial is being conducted in collaboration with the
Total revenue was
Research and development expenses were
More detailed financial information and analysis may be found in the
Company's Quarterly Report on Form 10-Q, which was filed with the
Based on our current operating levels, the Company expects its cash resources will be sufficient to fund operations into the first half of 2013. This estimate assumes no additional funding from new partnership agreements or equity financing events. Certain activities contemplated for 2012 would be conducted subject to the availability of additional financial resources.
Management will conduct a conference call at
The call also can be accessed by dialing (877) 407-8035 or (201)
689-8035 prior to the start of the call. For those unable to join the
live conference call, a replay will be available from
Ganetespib is a potent, 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. In these trials, ganetespib has shown clinical activity in heavily pretreated patients and has been well tolerated to date with no evidence of severe liver or common ocular toxicities seen with other Hsp90 inhibitors. The most common adverse event seen to date has been transient, mild or moderate diarrhea, which has been manageable with standard supportive care. Information on clinical trials with ganetespib can be found at www.clinicaltrials.gov.
About the Phase 2b/3 GALAXY TrialTM in NSCLC
The Phase 2b/3 trial will evaluate treatment with ganetespib and docetaxel vs. docetaxel alone, with 1:1 randomization, in patients with Stage IIIB or IV NSCLC who have completed one prior systemic therapy for advanced disease. The first stage, Phase 2b portion, will assess efficacy as measured by progression-free survival in approximately 240 patients. Results from this stage will also be used to inform the choice of patient subpopulation, by biomarker or other disease characteristic for the second stage, Phase 3 portion. The second stage may enroll up to 600 patients. More information on the trial can be found at www.clinicaltrials.gov.
About Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer-related mortality in
Safe Harbor Statement
This media release may contain forward-looking statements about
Synta Pharmaceuticals Corp.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended
|License and milestone revenues||$||—||$||1,143|
|Total collaboration revenues||—||1,143|
|Research and development||12,066||9,436|
|General and administrative||2,646||2,673|
|Total operating expenses||14,712||12,109|
|Loss from operations||(14,565||)||(10,966||)|
|Interest expense, net||(486||)||(435||)|
|Basic and diluted net loss per common share||$||(0.27||)||$||(0.27||)|
|Basic and diluted weighted average number of|
|common shares outstanding||56,366,992||42,008,818|
Synta Pharmaceuticals Corp.
Condensed Consolidated Balance Sheets Data
|March 31, 2012||December 31, 2011|
Cash, cash equivalents and
|Other current assets||608||561|
|Property, plant and equipment, net||1,324||1,407|
|Other non-current assets||
|Liabilities and Equity|
|Total liabilities and||$||59,841||$||42,324|
Synta Pharmaceuticals Corp.
George Farmer, 781-541-7125