NEW TAIPEI CITY, Taiwan, and SAN DIEGO, CA, USA I March 31, 2016 I Senhwa Biosciences, Inc. (“Senhwa” or the “Company”) today announced that Health Canada has approved IND.231, a phase I/II clinical trial of CX-5461, Senwha’s small molecule anti-cancer drug. Health Canada recently reviewed the Clinical Trial Application (CTA) submitted by the Canadian Cancer Trials Group (CCTG) and has issued a “No Objection Letter” (NOL) stating that Health Canada has no objection to the proposed Phase I/II clinical study, a standard response, allowing the CCTG to proceed with enrolling patients who meet the inclusion and exclusion criteria of the study.
The objectives of this Phase I/II study are to establish the safety profile and the recommended phase II dose for CX-5461, as well as explore efficacy in phase II. The phase II portion will enroll patients with Triple Negative Breast Cancer (TNBC) bearing either BRCA mutations or Homologous Recombination Repair Deficiencies (HRD), to confirm the efficacy of CX-5461 in Malignant Breast Cancers. The study is expected to begin enrolling patients in the second half of 2016.
Senhwa dedicates in the development of small molecule drugs for treating newly validated targets in cancer pathways. Its pipeline product portfolio includes two agents in clinical development for cancer, namely, CX-5461 and CX-4945. CX-5461 is currently undergoing a phase I study in hematological malignancies in Australia. Treatment with CX-5461 has so far demonstrated a good safety profile and is well tolerated.
For more detailed information on this clinical trial (study ID#: NCT02719977), please visit ClinicalTrials.gov
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.
SOURCE: Senhwa Biosciences
Post Views: 33
NEW TAIPEI CITY, Taiwan, and SAN DIEGO, CA, USA I March 31, 2016 I Senhwa Biosciences, Inc. (“Senhwa” or the “Company”) today announced that Health Canada has approved IND.231, a phase I/II clinical trial of CX-5461, Senwha’s small molecule anti-cancer drug. Health Canada recently reviewed the Clinical Trial Application (CTA) submitted by the Canadian Cancer Trials Group (CCTG) and has issued a “No Objection Letter” (NOL) stating that Health Canada has no objection to the proposed Phase I/II clinical study, a standard response, allowing the CCTG to proceed with enrolling patients who meet the inclusion and exclusion criteria of the study.
The objectives of this Phase I/II study are to establish the safety profile and the recommended phase II dose for CX-5461, as well as explore efficacy in phase II. The phase II portion will enroll patients with Triple Negative Breast Cancer (TNBC) bearing either BRCA mutations or Homologous Recombination Repair Deficiencies (HRD), to confirm the efficacy of CX-5461 in Malignant Breast Cancers. The study is expected to begin enrolling patients in the second half of 2016.
Senhwa dedicates in the development of small molecule drugs for treating newly validated targets in cancer pathways. Its pipeline product portfolio includes two agents in clinical development for cancer, namely, CX-5461 and CX-4945. CX-5461 is currently undergoing a phase I study in hematological malignancies in Australia. Treatment with CX-5461 has so far demonstrated a good safety profile and is well tolerated.
For more detailed information on this clinical trial (study ID#: NCT02719977), please visit ClinicalTrials.gov
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.
SOURCE: Senhwa Biosciences
Post Views: 33
