Expansion Phase to Include Patients With Ovarian Cancer and Certain Hematologic Malignancies
LEXINGTON, MA, USA I June 5, 2014 I Curis, Inc. (CRIS), an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced that it has re-initiated dosing in the single-agent clinical trial of CUDC-427 in patients with advanced and/or refractory solid tumors or lymphomas. CUDC-427 is a novel, oral small molecule that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins that support survival of cancer cells.
The primary objective of the monotherapy study under the amended protocol is to determine the safety and recommended Phase 2 dose for CUDC-427 when administered orally once daily for two weeks, followed by a one week rest period in 21-day cycles until disease progression or study discontinuation. The study is expected to enroll patients in consecutive cohorts at dose levels of 100 to 300 mg per day. In addition to safety and tolerability measures, the amended protocol is designed to enroll patients in an expansion cohort, which is planned to be limited to patients with ovarian or certain hematologic cancers, including mucosa-associated lymphoid tissue (MALT) lymphoma.
“We are pleased that patients can once again receive CUDC-427 and are looking forward to further investigating this drug candidate’s potential as a single agent,” said Anthony W. Tolcher, M.D., FRCP, Director of Clinical Research at South Texas Accelerated Research Therapeutics (START). “We will continue to analyze specific genetic alterations and molecular signatures that may render certain patients’ cancers more susceptible to CUDC-427’s effects.”
“We are pleased to have re-opened enrollment on the CUDC-427 monotherapy trial at START and Sarah Cannon Research Institute with risk mitigation measures designed to ensure patient safety,” said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. “We continue to believe in CUDC-427’s potential as an anti-cancer agent either as a single agent or in combination settings in select cancer types.”
“We look forward to building and expanding upon the promising clinical results previously observed with CUDC-427,” added Jeffrey Infante, M.D., Director of Drug Development Program at the Sarah Cannon Research Institute (SCRI).
About the Phase 1 Dose Escalation Trial
This Phase 1, open-label, multicenter study is designed to determine the safety and recommended Phase 2 dose of oral CUDC-427 administered once daily as a single agent on a 14 days on/7 days off schedule in 21-day cycles in patients with advanced and/or refractory solid tumors or lymphoma. The secondary objectives of the study are to assess CUDC-427’s tolerability, pharmacokinetics, exploratory biomarkers of activity and preliminary anti-cancer activity. Patients are expected to be enrolled in consecutive cohorts according to the standard 3+3 design at once daily dose levels ranging from 100 to 300 mg. Upon determination of the recommended Phase 2 dose, the trial is designed to enroll expansion cohorts with up to 12 more patients with a particular type of cancer. For additional details, please refer to www.clinicaltrials.gov (NCT01908413).
About CUDC-427
CUDC-427 is an oral, small molecule Smac mimetic that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins. IAP proteins are a family of functionally and structurally related proteins that promote cancer cell survival by inhibiting programmed cell death, also known as apoptosis, which is a normal process inherent in every cell. Using IAP proteins and other anti-apoptotic factors, cancer cells evade apoptosis in response to a variety of signals, including those provided by anti-cancer agents such as chemotherapy, or naturally occurring inflammatory and immune signals transmitted through members of the tumor necrosis factor (TNF) family. IAP inhibitors such as CUDC-427 are designed to counteract the effects of IAP proteins, thus shifting the balance away from cancer cell survival and allowing apoptosis to proceed.
About Curis, Inc.
Curis is an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers. Curis is seeking to further the development of its pipeline of drug candidates, including CUDC-907, a dual histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) inhibitor, and CUDC-427, a small molecule antagonist of IAP proteins. Curis is also engaged in a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are developing and commercializing Erivedge(R), the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma. Curis’ HSP90 inhibitor, Debio 0932 is being studied in patients with advanced lung and kidney cancers by partner Debiopharm. For more information, visit Curis’ website at www.curis.com.
SOURCE: Curis
Post Views: 118
Expansion Phase to Include Patients With Ovarian Cancer and Certain Hematologic Malignancies
LEXINGTON, MA, USA I June 5, 2014 I Curis, Inc. (CRIS), an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced that it has re-initiated dosing in the single-agent clinical trial of CUDC-427 in patients with advanced and/or refractory solid tumors or lymphomas. CUDC-427 is a novel, oral small molecule that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins that support survival of cancer cells.
The primary objective of the monotherapy study under the amended protocol is to determine the safety and recommended Phase 2 dose for CUDC-427 when administered orally once daily for two weeks, followed by a one week rest period in 21-day cycles until disease progression or study discontinuation. The study is expected to enroll patients in consecutive cohorts at dose levels of 100 to 300 mg per day. In addition to safety and tolerability measures, the amended protocol is designed to enroll patients in an expansion cohort, which is planned to be limited to patients with ovarian or certain hematologic cancers, including mucosa-associated lymphoid tissue (MALT) lymphoma.
“We are pleased that patients can once again receive CUDC-427 and are looking forward to further investigating this drug candidate’s potential as a single agent,” said Anthony W. Tolcher, M.D., FRCP, Director of Clinical Research at South Texas Accelerated Research Therapeutics (START). “We will continue to analyze specific genetic alterations and molecular signatures that may render certain patients’ cancers more susceptible to CUDC-427’s effects.”
“We are pleased to have re-opened enrollment on the CUDC-427 monotherapy trial at START and Sarah Cannon Research Institute with risk mitigation measures designed to ensure patient safety,” said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. “We continue to believe in CUDC-427’s potential as an anti-cancer agent either as a single agent or in combination settings in select cancer types.”
“We look forward to building and expanding upon the promising clinical results previously observed with CUDC-427,” added Jeffrey Infante, M.D., Director of Drug Development Program at the Sarah Cannon Research Institute (SCRI).
About the Phase 1 Dose Escalation Trial
This Phase 1, open-label, multicenter study is designed to determine the safety and recommended Phase 2 dose of oral CUDC-427 administered once daily as a single agent on a 14 days on/7 days off schedule in 21-day cycles in patients with advanced and/or refractory solid tumors or lymphoma. The secondary objectives of the study are to assess CUDC-427’s tolerability, pharmacokinetics, exploratory biomarkers of activity and preliminary anti-cancer activity. Patients are expected to be enrolled in consecutive cohorts according to the standard 3+3 design at once daily dose levels ranging from 100 to 300 mg. Upon determination of the recommended Phase 2 dose, the trial is designed to enroll expansion cohorts with up to 12 more patients with a particular type of cancer. For additional details, please refer to www.clinicaltrials.gov (NCT01908413).
About CUDC-427
CUDC-427 is an oral, small molecule Smac mimetic that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis (IAP) proteins. IAP proteins are a family of functionally and structurally related proteins that promote cancer cell survival by inhibiting programmed cell death, also known as apoptosis, which is a normal process inherent in every cell. Using IAP proteins and other anti-apoptotic factors, cancer cells evade apoptosis in response to a variety of signals, including those provided by anti-cancer agents such as chemotherapy, or naturally occurring inflammatory and immune signals transmitted through members of the tumor necrosis factor (TNF) family. IAP inhibitors such as CUDC-427 are designed to counteract the effects of IAP proteins, thus shifting the balance away from cancer cell survival and allowing apoptosis to proceed.
About Curis, Inc.
Curis is an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers. Curis is seeking to further the development of its pipeline of drug candidates, including CUDC-907, a dual histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) inhibitor, and CUDC-427, a small molecule antagonist of IAP proteins. Curis is also engaged in a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are developing and commercializing Erivedge(R), the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma. Curis’ HSP90 inhibitor, Debio 0932 is being studied in patients with advanced lung and kidney cancers by partner Debiopharm. For more information, visit Curis’ website at www.curis.com.
SOURCE: Curis
Post Views: 118
