Senhwa Announces Enrollment of First Patient in Phase I/II CX-5461 Trial in Triple Negative Breast Cancer

NEW TAIPEI CITY, Taiwan and SAN DIEGO, CA, USA I June 14, 2016 I Senhwa Biosciences, Inc. ("Senhwa" or the "Company") announced today enrollment of the first patient in a multicenter Phase I/II clinical trial to evaluate Senhwa's investigational product CX-5461 in triple-negative breast cancer (TNBC) patients with known BRCA1/2 mutation or Homologous Recombination Defect (HRD). This trial will study the use of CX-5461, a small molecule G-quadruplex stabilizer, to selectively kill tumors defective in the BRCA1/2 or HR related genes through the concept of synthetic lethality.  

BRCA1/2 mutations or HRD is believed to account for approximately 50% of the TNBC population. TNBC is the most aggressive of all breast cancers and unlike the other types of breast cancer, TNBC currently has limited treatment options.

"There is a high unmet medical need in this setting that must be filled. Positive result in this indication may propel the development of CX-5461 in additional solid tumor indications, such as ovary, lung, pancreas, prostate, and gastrointestinal (GI) tract cancers," stated John Soong, MD, Senior Medical Officer at Senhwa Biosciences.

The Canadian Cancer Trials Group (CCTG) is the sponsor of the study, which will be conducted with the support of the Ontario Institute for Cancer Research through funding provided by the Government of Ontario. SU2C Canada-Canadian Breast Cancer Foundation Breast Cancer Dream Team-affiliated physicians and scientists from the BC Cancer Agency, Ottawa Hospital Research Institute, and University Health Network (Toronto) are participating.

The multicenter Phase I/II trial will initially assess the safety and tolerability of increasing doses of CX-5461, followed by a Simon 2-stage study that assesses antitumor activity in TNBC patients with BRCA1/2 mutations or HRD. The primary endpoint is the evaluation of the Objective Response Rate (ORR). Secondary endpoints, including Progression Free Survival (PFS), will be assessed using RECIST criteria. Further details about the study may be found on www.clinicaltrials.gov.

About CX-5461 and DNA repair

CX-5461 has been administered in Phase 1 clinical trials to fourteen patients with advanced haematologic malignancies. CX-5461 is well tolerated with low grade manageable adverse events to date. To date, this study has not yet reached a MTD and the trial continues to enroll patients with dose escalation.

CX-5461 is a potent G-quadruplex stabilizer that trigger replication and transcription associated DNA damage in cancer cells with defective DNA damage repair due to BRCA1/2 mutation or HR deficiency. Normal cells have all of their DNA repair mechanisms intact allowing them to survive. By stabilizing G-quadruplex, CX-5461 selectively kill tumors through the concept of synthetic lethality.

About Senhwa Biosciences, Inc.

Senhwa Biosciences identifies and develops innovative therapies that have the potential to fundamentally change the way patients are treated. Our central philosophy is to unearth validated targets or therapies that could significantly improve cancer treatments, but have not yet been properly exploited. As a value-added development company, Senhwa aims to take innovative therapies that could impact the current standard of care and drive them through clinical Proof-of-Concept. Senhwa is headquartered in Taiwan, but with subsidiary located in San Diego, CA, the Senhwa Team is well positioned to oversee the development of their compounds by collaborating with a diverse range of global Investigators and service providers. Clinical trials are ongoing or planned for Australia, Canada, U.S.A. and Asia, and service providers work from their bases in North America, Asia, Australia and Europe. For more information on Senhwa and its programs, please visit www.senhwabiosciences.com.

About Canadian Cancer Trials Group (CCTG)

The CCTG is the only Canadian cooperative cancer trials group conducting the entire range of cancer trials from early phase studies to large international randomized controlled trials across all cancer types. Its primary mission is to assess the effectiveness of interventions to prevent the development of cancer or improve the care of those patients who do develop cancer. It is a national research program of the Canadian Cancer Society. Its Central Operations and Statistics Centre is located at Queen's University in Kingston, Ontario, Canada. For more information on CCTG, please visit https://www.ctg.queensu.ca/.

SOURCE: Senhwa Biosciences

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