Trial Expected to Enroll Patients With Hormone Receptor Positive Breast Cancer and Patients With Midline Carcinoma With NUT Rearrangement
LEXINGTON, MA, USA I December 18, 2014 I Curis, Inc. (CRIS), an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced that the first patient has initiated treatment with CUDC-907 in a Phase 1 clinical trial in patients with advanced or relapsed solid tumors, including hormone receptor positive (HR+)/ HER2-negative breast cancer or midline carcinoma with certain NUT gene rearrangements. CUDC-907 is an oral, dual inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) enzymes that is currently under investigation in the first-in-human Phase 1 clinical study in patients with relapsed or refractory lymphomas and multiple myeloma.
“We look forward to investigating the therapeutic potential of CUDC-907, a molecule with the unique ability to inhibit both HDAC and PI3K enzymes, in patients with hormone receptor positive breast cancer,” said Pamela Munster, M.D., Principal Investigator of the study and Professor, Department of Medicine (Hematology/Oncology) at the University of California, San Francisco’s Helen Diller Family Comprehensive Cancer Center. “Scientifically, CUDC-907 merits evaluation in patients with HR+ breast cancer in combination with hormonal therapy as HDACs are critical components of the estrogen receptor transcriptional complex. Additionally, the high prevalence of alterations in the PI3K pathway further supports the rationale of testing the molecule in this specific subset of patients with breast cancer.”
“We are excited to initiate this study with CUDC-907 in patients with HR+ breast cancer and in patients with NUT midline carcinoma or NMC, a rare, aggressive cancer, genetically defined by rearrangements of the NUT gene,” said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. “There are currently no therapies for patients with NMC. However, Curis’ preclinical data and other published results in the field have demonstrated that NMCs may be sensitive to treatment with molecules that inhibit HDAC enzymes such as CUDC-907. Based on these data, we are eager to further investigate the potential of CUDC-907 in the treatment of patients with NMC.”
About the Upcoming Solid Tumor Phase 1 Study
The solid tumor study is an open label, multi-center study to assess the safety, tolerability and pharmacokinetics of CUDC-907 in subjects with advanced, relapsed solid tumors, including hormone receptor positive breast cancer or midline carcinoma with NUT rearrangement. In the case of breast cancer, tumors must be estrogen receptor (ER+) and/or progesterone receptor (PR+) positive and HER2-negative, with disease progression following treatment with at least one prior hormonal therapy for advanced/metastatic disease or disease relapse while on adjuvant hormonal therapy. Additionally, ongoing treatment with tamoxifen, anastrozole, exemestane or letrozole is allowed.
The primary objective of this study is to determine the safety and tolerability of oral CUDC-907 using the recommended schedules of administration that have already been identified in the first-in-human trial of CUDC-907, namely 5 days “on”/2 days “off” weekly or three times a week in 21 day cycles. The secondary objectives of this study are to assess the plasma and tissue pharmacokinetics, to establish the maximum tolerated dose, the recommended Phase 2 dose in patients with solid tumor malignancies, to evaluate biomarkers of activity and the preliminary anti-cancer activity of CUDC-907.
For additional details regarding the study, please refer to www.clinicaltrials.gov (Identifier:NCT02307240)
About CUDC-907:
CUDC-907 is an oral, dual inhibitor of Class I and II HDAC, as well as Class I PI3K enzymes. Specifically, CUDC-907 is designed to inhibit HDACs 1, 2, 3, 6 and 10 and PI3K-alpha, delta and beta isoforms. CUDC-907 is currently undergoing investigation in a first-in-human trial to assess its safety, pharmacokinetics and preliminary anti-cancer activity in patients with relapsed/refractory lymphomas and multiple myeloma. The development of CUDC-907 is in part supported by The Leukemia & Lymphoma Society (LLS) under a funding agreement established in 2011 between Curis and LLS’s Therapy Acceleration Program. For additional details of CUDC-907’s Phase 1 studies, please refer to www.clinicaltrials.gov (study identifiers: NCT01742988 and NCT02307240).
About Curis, Inc.
Curis is an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers. Curis’ pipeline of drug candidates includes CUDC-907, a dual HDAC and PI3K inhibitor, CUDC-427, a small molecule antagonist of IAP proteins and Debio 0932, an oral HSP90 inhibitor. 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. For more information, visit Curis’ website at www.curis.com.
SOURCE: Curis
Post Views: 58
Trial Expected to Enroll Patients With Hormone Receptor Positive Breast Cancer and Patients With Midline Carcinoma With NUT Rearrangement
LEXINGTON, MA, USA I December 18, 2014 I Curis, Inc. (CRIS), an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced that the first patient has initiated treatment with CUDC-907 in a Phase 1 clinical trial in patients with advanced or relapsed solid tumors, including hormone receptor positive (HR+)/ HER2-negative breast cancer or midline carcinoma with certain NUT gene rearrangements. CUDC-907 is an oral, dual inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) enzymes that is currently under investigation in the first-in-human Phase 1 clinical study in patients with relapsed or refractory lymphomas and multiple myeloma.
“We look forward to investigating the therapeutic potential of CUDC-907, a molecule with the unique ability to inhibit both HDAC and PI3K enzymes, in patients with hormone receptor positive breast cancer,” said Pamela Munster, M.D., Principal Investigator of the study and Professor, Department of Medicine (Hematology/Oncology) at the University of California, San Francisco’s Helen Diller Family Comprehensive Cancer Center. “Scientifically, CUDC-907 merits evaluation in patients with HR+ breast cancer in combination with hormonal therapy as HDACs are critical components of the estrogen receptor transcriptional complex. Additionally, the high prevalence of alterations in the PI3K pathway further supports the rationale of testing the molecule in this specific subset of patients with breast cancer.”
“We are excited to initiate this study with CUDC-907 in patients with HR+ breast cancer and in patients with NUT midline carcinoma or NMC, a rare, aggressive cancer, genetically defined by rearrangements of the NUT gene,” said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. “There are currently no therapies for patients with NMC. However, Curis’ preclinical data and other published results in the field have demonstrated that NMCs may be sensitive to treatment with molecules that inhibit HDAC enzymes such as CUDC-907. Based on these data, we are eager to further investigate the potential of CUDC-907 in the treatment of patients with NMC.”
About the Upcoming Solid Tumor Phase 1 Study
The solid tumor study is an open label, multi-center study to assess the safety, tolerability and pharmacokinetics of CUDC-907 in subjects with advanced, relapsed solid tumors, including hormone receptor positive breast cancer or midline carcinoma with NUT rearrangement. In the case of breast cancer, tumors must be estrogen receptor (ER+) and/or progesterone receptor (PR+) positive and HER2-negative, with disease progression following treatment with at least one prior hormonal therapy for advanced/metastatic disease or disease relapse while on adjuvant hormonal therapy. Additionally, ongoing treatment with tamoxifen, anastrozole, exemestane or letrozole is allowed.
The primary objective of this study is to determine the safety and tolerability of oral CUDC-907 using the recommended schedules of administration that have already been identified in the first-in-human trial of CUDC-907, namely 5 days “on”/2 days “off” weekly or three times a week in 21 day cycles. The secondary objectives of this study are to assess the plasma and tissue pharmacokinetics, to establish the maximum tolerated dose, the recommended Phase 2 dose in patients with solid tumor malignancies, to evaluate biomarkers of activity and the preliminary anti-cancer activity of CUDC-907.
For additional details regarding the study, please refer to www.clinicaltrials.gov (Identifier:NCT02307240)
About CUDC-907:
CUDC-907 is an oral, dual inhibitor of Class I and II HDAC, as well as Class I PI3K enzymes. Specifically, CUDC-907 is designed to inhibit HDACs 1, 2, 3, 6 and 10 and PI3K-alpha, delta and beta isoforms. CUDC-907 is currently undergoing investigation in a first-in-human trial to assess its safety, pharmacokinetics and preliminary anti-cancer activity in patients with relapsed/refractory lymphomas and multiple myeloma. The development of CUDC-907 is in part supported by The Leukemia & Lymphoma Society (LLS) under a funding agreement established in 2011 between Curis and LLS’s Therapy Acceleration Program. For additional details of CUDC-907’s Phase 1 studies, please refer to www.clinicaltrials.gov (study identifiers: NCT01742988 and NCT02307240).
About Curis, Inc.
Curis is an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers. Curis’ pipeline of drug candidates includes CUDC-907, a dual HDAC and PI3K inhibitor, CUDC-427, a small molecule antagonist of IAP proteins and Debio 0932, an oral HSP90 inhibitor. 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. For more information, visit Curis’ website at www.curis.com.
SOURCE: Curis
Post Views: 58
