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Senhwa Biosciences Initiates Phase 1/2 Trial Of CX-4945 In Combination With Gemcitabine And Cisplatin



6/17/2014 10:19:13 AM

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SAN DIEGO and NEW TAIPEI CITY, Taiwan, June 17, 2014 /PRNewswire-iReach/ -- Senhwa Biosciences, Inc. announced today that the Company has initiated a randomized Phase 1b/2 Trial of CX-4945 in combination with gemcitabine and cisplatin for the frontline treatment of patients with bile duct cancers (cholangiocarcinoma). This Proof-of-Concept trial will study the use of CX-4945, a small molecule CK2 inhibitor, to suppress DNA repair mediated resistance and boost the efficacy of the widely used chemotherapy agents.

Photo - http://photos.prnewswire.com/prnh/20140613/118183

"We are delighted to be conducting a Phase 2 trial in frontline patients with cholangiocarcinoma, a population with poor prognosis and limited treatment options. Bile duct cancers are increasing in prevalence globally, and are of particular significance and concern in emerging Asian markets," stated Dr. Tai-Sen Soong, President of Senhwa Biosciences. "This Proof-of-Concept study is designed to evaluate the combination of CX-4945 with DNA damaging chemotherapy agents. Positive results in this orphan indication may propel the development of CX-4945 toward similar combination chemotherapies in additional solid tumor indications, such as breast, lung and bladder cancers, with greater incidence and substantial markets."

The clinical trial has been initiated at the Mayo Clinic Cancer Center, Scottsdale, AZ where Dr. Mitesh Borad M.D., Director, Phase I Drug Development is global Principal Investigator of the CX-4945 cholangiocarcinoma study. The multi-center Phase 2 trial will initially assess the safety and tolerability of increasing doses of CX-4945 in combination with gemcitabine plus cisplatin, followed by a randomized study that compares antitumor activity in cholangiocarcinoma patients receiving either the standard of care gemcitabine plus cisplatin, or CX-4945 combined with gemcitabine plus cisplatin. The primary end point is the comparison of the Objective Response Rate (ORR) and Progression Free Survival (PFS) between the test and control arms using RECIST criteria. Secondary endpoints including Overall Survival (OS) will also be monitored. Further details about the study may be found on www.clinicaltrials.gov.

About CX-4945 and DNA repair

CX-4945 has previously been administered in Phase 1 clinical trials to fifty-two patients with advanced solid tumors. The drug was well tolerated and showed evidence of CK2 inhibition. CK2 is a protein kinase with elevated activity in many cancers and has a direct role in DNA damage repair. The DNA repair pathways enable tumor cells to survive damage induced by treatment with chemotherapeutic agents. Inhibitors of DNA repair pathways have been shown to increase the efficacy of DNA damaging chemotherapeutic drugs when these are used in combination. Normal cells do not replicate as rapidly as fast growing cancer cells and have all of their DNA repair mechanisms intact allowing them to survive the temporary shutdown of one or more of these pathways. Inhibiting CK2 with CX-4945 has been shown to inhibit DNA repair, and this augments the lethality of the DNA damage in cancer cells caused by chemotherapy treatment.

About Cholangiocarcinoma

Cholangiocarcinomas are malignancies arising from the epithelial cells of the intrahepatic and extrahepatic bile ducts. The incidence of disease varies greatly throughout the world, being 0.5-3 individuals per 100,000 in European countries to over 80 individuals per 100,000 in parts of South-East Asia. Data from the American Cancer Society suggests that there are 11,000 cases annually in the USA, although estimates vary due to differences in classification and diagnoses. The high mortality of this disease is due to its late detection and the fact that fewer than 10% of those with bile duct cancer are surgical candidates. The standard of care treatment for unresectable cholangiocarcinoma is a combination of gemcitabine and cisplatin.

About Senhwa Biosciences

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 treatment, 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 has a strong Management Team with proven track records in developing new drugs and targeted agents. Headquartered in Taiwan, but with a clinical operations base 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, the USA 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.

Media Contact:Sean O'Brien, Senhwa Biosciences, 8585526808, sobrien@senhwabio.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE Senhwa Biosciences



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