Webcast and Conference Call Today,
“Since the beginning of this year, ganetespib has reached several
important clinical milestones across studies and cancer types, including
encouraging results from the GALAXY-1 and ENCHANT Phase 2 studies in
lung and breast cancer, and graduation to the Phase 3 extension in the
AML LI-1 trial,” said
Second Quarter and Recent Updates
Enrollment in GANNET53 Trial of Ganetespib in Ovarian Cancer
Commences. The Company announced today that GANNET53, a
Seventh Framework Programme (FP7) research project funded by the
European Commission, has begun enrolling patients in the safety lead-in Phase 1 portion of the trial. GANNET53 is a pan-European randomized trial designed to evaluate the combination of ganetespib and paclitaxel vs. paclitaxel alone in over 200 patients with metastatic, platinum-resistant ovarian cancer, which is commonly associated with p53 mutations. The study’s consortium consists of national clinical trial groups in gynecological oncology and high-volume university centers as well as noted p53 scientists and three innovative small and medium sized companies (SMEs).
Ganetespib Advances into Phase 3 Extension of AML LI-1 Study in
AML and High-Risk MDS; AML-18 and AML-19 Trials on Track to Initiate
in 2H 2014. In
July 2014, Synta announced the advancement of ganetespib into the Phase 3 extension of the AML LI-1 (less intensive) trial. AML LI-1 is a multicenter, randomized Phase 2/3 clinical study evaluating several novel treatment regimens, including the combination of ganetespib with low dose cytarabine (Ara-C), in newly diagnosed elderly patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) who are not eligible for intensive chemotherapy.
Advancement into the Phase 3 extension follows an interim analysis of results from 50 patients who received the ganetespib-cytarabine combination in the Phase 2 portion of the trial. The primary efficacy outcome in Phase 2 was rate of complete response. Per the protocol, the Phase 3 extension will include an interim futility analysis and enroll approximately 200 patients in the ganetespib-cytarabine and the cytarabine alone arms, for a total of approximately 400 patients. The primary efficacy endpoint for the Phase 3 extension will include overall survival. The Company is currently in discussion with study investigators, and anticipates providing additional details, including the timing of study milestones, as they become formalized.
The AML LI-1 trial is the first of three multicenter, randomized studies
supported by the
Reported Results from Final Analysis of GALAXY-1 Study; GALAXY-2
Clinical Trial Remains on Track to Meet Data Readout Timelines.
May 2014, Synta reported final results from the global, randomized, multi-center Phase 2b GALAXY-1 study comparing the combination of ganetespib and docetaxel to docetaxel alone for the second-line treatment of advanced non-small cell adenocarcinoma. The final results from this trial, in particular the encouraging overall survival results and tolerability profile in chemosensitive patients, supports the selection of the chemosensitive population for the pivotal Phase 3 GALAXY-2 trial.
Synta also reported that the Company’s pivotal, Phase 3 GALAXY-2 trial of ganetespib and docetaxel vs. docetaxel alone for the 2nd line treatment of patients with NSCLC adenocarcinoma remains on track to meet previously guided data readout timelines. With a target enrollment of approximately 850 patients, and based on current projections and statistical assumptions, Synta continues to expect the two interim efficacy analyses of GALAXY-2 to be conducted by the independent Data Monitoring Committee (DMC) in the second half of 2015 and the final analysis to be conducted in the first half of 2016.
Second Quarter 2014 Financial Results
There were no revenues recognized in the second quarters of 2014 and 2013.
Research and development expenses were
The Company reported a net loss of
In the second quarter of 2014, the Company raised an aggregate of
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 its current operating levels, the Company expects its cash
resources of approximately
Synta will host a conference call at
The conference call can be accessed by dialing (877) 407-8035 (U.S.) or
(201) 689-8035 (International). For those unable to join the live call,
a replay will be available from
The live webcast
can be accessed by visiting the Investor
Relations section of the
Ganetespib, an investigational drug candidate, is a selective inhibitor
of heat shock protein 90 (Hsp90), a molecular chaperone which controls
the folding and activation of a number of client proteins that drive
tumor development and progression. Many solid and hematologic tumors are
dependent on Hsp90 client proteins including proteins involved in
“oncogene addiction” (ALK, HER2, mutant BRAF and EGFR, androgen
receptor, estrogen receptor, and JAK2); proteins involved in resistance
to chemotherapy and radiation therapy (ATR, BCL2, BRCA1/2, CDK1/4, CHK1,
survivin, and WEE1); proteins involved in angiogenesis (HIF-1alpha,
VEGFR, PDFGR, and VEGF); and proteins involved in metastasis (MET, RAF,
AKT, MMPs, HIF-1alpha, and IGF-1R). In preclinical models, inhibition of
Hsp90 by ganetespib results in the inactivation, destabilization, and
eventual degradation of these cancer-promoting proteins. Ganetespib is
being evaluated in trials in lung cancer, breast cancer, and other tumor
types. 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 these trials can be found at
www.clinicaltrials.gov. Ganetespib has received Fast Track designation
About Hsp90 inhibitor Drug Conjugates (HDC)
HDCs are small-molecule drugs consisting of an Hsp90 inhibitor (targeting moiety) joined to an anti-cancer agent (payload) via a cleavable chemical linker optimized for controlled release of payload drug inside cancer cells. They exploit the preferential retention of Hsp90 inhibitors in tumors to selectively deliver anti-cancer payloads. HDCs represent a promising new therapeutic class with the potential to enhance the safety and efficacy of a wide range of small molecule anti-cancer drugs.
Synta has established proof of concept for HDC lead candidates in preclinical studies and has developed HDCs using a range of Hsp90 inhibitor moieties, cleavable linkers, and over 40 anti-cancer payloads. The latter include cytotoxic chemotherapeutics, kinase inhibitors, hormone therapies, immunomodulators, and epigenetic modifiers, creating the potential for next-generation compounds in each of these categories. Synta has filed worldwide patent applications that include comprehensive claims covering the HDC platform, compositions of matter, methods for identifying therapeutically effective compounds, and methods of use of such compounds against a wide range of diseases and conditions.
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
Six Months Ended
|Research and development||18,761||17,876||36,344||34,256|
|General and administrative||2,940||4,187||8,264||8,065|
|Total operating expenses||21,701||22,063||44,608||42,321|
|Loss from operations||(21,701||)||(22,063||)||(44,608||)||(42,321||)|
|Interest expense, net||(585||)||(724||)||(1,235||)||(1,194||)|
|Net loss||$ (22,286||)||$||(22,787||)||$||(45,843||)||$||(43,515||)|
|Basic and diluted net loss per common share||$(0.24||)||$||(0.33||)||$||(0.51||)||$||(0.63||)|
Basic and diluted weighted average number
Synta Pharmaceuticals Corp.
Condensed Consolidated Balance Sheets
|Cash, cash equivalents and marketable securities||$||112,060||$||91,476|
|Other current assets||2,264||765|
|Property, plant and equipment, net||1,264||1,553|
|Other non-current assets||358||1,409|
|Liabilities and Equity|
Total liabilities and
Synta Pharmaceuticals Corp.
Daniel Cole, 781-541-7250
Andrea Rabney, 212-600-1494
Eliza Schleifstein, 917-763-8106