Our lead clinical candidate is ganetespib, a selective inhibitor of the Hsp90 chaperone protein, which is being evaluated in over 25 clinical trials that have enrolled over a thousand patients to date, including our GALAXY program in lung cancer and our ENCHANT program in breast cancer.
The GALAXY program in lung cancer
At the 2013 meeting of the
- In the all-adenocarcinoma population (N=252), the ganetespib combination arm showed improved overall survival, progression-free survival, and response rate compared to the docetaxel arm.
- A statistical interaction test showed that one of the four prospectively-defined stratification factors was strongly predictive of ganetespib activity (p=0.006). Patients with "chemo-sensitive" disease (N=176; 70%) derived substantially greater benefit from ganetespib than patients with "chemo-refractory" disease (N=76; 30%).
- In the chemo-sensitive population, defined as time since diagnosis of advanced disease greater than six months, median overall survival increased from 6.4 to 10.7 months, and the Hazard ratio was 0.61 (1-sided p=0.009), corresponding to a 39% reduction in the risk of death.
- The rate of new lesion formation decreased by 50% in patients treated with ganetespib (Hazard ratio 0.50, p=0.005). This observation is consistent with preclinical and clinical results suggesting ganetespib inhibits the biological pathways that drive angiogenesis (new blood vessel formation) and metastasis (the spread of tumors) in cancer cells.
- Transient, mild-to-moderate diarrhea, manageable with OTC medication, was the most common adverse event observed with ganetespib, consistent with observations from other clinical trials. Other adverse events increased relative to control included mild to moderate anemia and fatigue, as well as an increase in the number of cases of febrile neutropenia.
Based on our current event rate projections, Synta expects the final analysis of the GALAXY-1 trial to be conducted in the fourth quarter of 2013.
The GALAXY-2 trial evaluates the same dose, schedule, and regimen as the GALAXY-1 trial, but in a larger population (N=500), with overall survival as the primary endpoint, and in chemo-sensitive patients. Trial enrollment began in the second quarter of 2013. Based on our current projections, Synta expects the first interim analysis of the GALAXY-2 trial to be conducted in the first half of 2014, and the second interim and final analyses to be conducted in the second half of 2014.
The ENCHANT program in breast cancer
Some of the strongest evidence for the role of Hsp90 in fueling cancer growth is from breast cancer: reduced expression of tumor Hsp90 is associated with significantly longer patient survival .
Based on the supportive scientific findings, evidence of single-agent clinical activity for ganetespib in triple-negative breast cancer, the widespread use of taxanes in this disease, and the positive results for ganetespib in combination with docetaxel in lung cancer, Synta has developed two registration programs focusing on triple-negative breast cancer. The first is in the metastatic setting, and the second is in the neo-adjuvant setting. Synta expects those programs to initiate in 2014, pending completion of certain ongoing partnership discussions.
Recently announced clinical results from the ENCHANT-1 trial have confirmed prior signals of single-agent clinical activity. Synta expects results from ENCHANT-1 will be presented at a medical conference later this year.
Other trials with ganetespib
A number of investigator and cooperative group-sponsored trials are ongoing, including trials in breast cancer in combination with fulvestrant, in multiple myeloma with bortezomib, in ALK+ NSCLC with crizotinib, in rectal cancer with chemoradiotherapy, and in AML with low-dose Ara-C. Additional trials are expected to initiate later this year or early next year including in mesothelioma with pemetrexed and cisplatin, in HER2+ breast cancer with trastuzumab and paclitaxel, in ovarian cancer with paclitaxel and carboplatin, in pancreatic cancer in combination with nab-paclitaxel and gemcitabine, and in prostate cancer with radiotherapy.
“We have made strong progress this quarter in advancing ganetespib
development in both lung cancer and breast cancer,” said
There were no revenues recognized in the second quarters of 2013 and 2012.
Research and development expenses were
The Company reported a net loss 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 our current operating levels the Company expects its cash
resources of approximately
Management will conduct a conference call at
The call can also be accessed by dialing (877) 407-8035 or (201)
689-8035 prior to the start of the call. A replay will be available from
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, 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. Information on these trials can be found at www.clinicaltrials.gov.
About the GALAXY Program
The GALAXY (Ganetespib Assessment in Lung cAncer with docetaXel) program consists of two randomized trials comparing the combination of ganetespib and docetaxel versus docetaxel alone in patients with Stage IIIB/IV NSCLC who have received one prior systemic therapy: a 300-patient Phase 2b/3 trial (GALAXY-1) to determine the patient population most likely to derive benefit from ganetespib, and a 500-patient confirmatory Phase 3 trial (GALAXY-2). More information about the GALAXY trials can be found at www.clinicaltrials.gov (NCT01348126 and NCT01798485).
About the ENCHANT-1 Clinical Trial
ENCHANT-1 is a proof-of-concept, ”window-of-opportunity” trial designed to evaluate single-agent ganetespib safety and clinical activity in locally advanced or first line metastatic HER2-positive and triple-negative breast cancer. The trial will also evaluate the combination of ganetespib with paclitaxel. More information about this trial can be found at www.clinicaltrials.gov (NCT01677455)
About Lung Cancer
Lung cancer is the leading cause of cancer-related death in the world,
accounting for nearly 1.4 million deaths in 2008, according to the
About Breast Cancer
Breast cancer is the most frequent cancer in women, accounting for
458,000 deaths worldwide in 2008, according to the
Safe Harbor Statement
This media release may contain forward-looking statements about
1. Q. Cheng et al, “Amplification and high-level expression of heat
Synta Pharmaceuticals Corp.
Three Months Ended
Six Months Ended
|Research and development||17,876||11,252||34,256||23,318|
|General and administrative||4,187||2,882||8,065||5,528|
|Total operating expenses||22,063||14,134||42,321||28,846|
|Loss from operations||(22,063||)||(14,134||)||(42,321||)||(28,699||)|
|Interest expense, net||(724||)||(486||)||(1,194||)||(972||)|
|Basic and diluted net loss per common share||$||(0.33||)||$||(0.25||)||$||(0.63||)||$||(0.52||)|
Basic and diluted weighted average number
of common shares outstanding
Synta Pharmaceuticals Corp.
Cash, cash equivalents and marketable
|Other current assets||1,637||786|
|Property, plant and equipment, net||1,620||1,174|
|Other non-current assets||464||458|
|Liabilities and Equity|
Total liabilities and