Trial is being conducted in collaboration with the GOG Foundation
CAMBRIDGE, MA, USA I July 21 2015 I Cerulean Pharma Inc. (Nasdaq: CERU) today announced that the first patient has been dosed in an open label Phase 1b clinical trial of its lead product candidate, CRLX101, in combination with weekly paclitaxel in patients with relapsed ovarian cancer by the University of Virginia School of Medicine. This trial is being conducted by Cerulean in collaboration with the GOG Foundation under the direction of principal investigator, Carolyn N. Krasner, M.D., of the Massachusetts General Hospital Cancer Center.
“Relapsed ovarian cancer is an area of high unmet medical need,” said Chris Guiffre, Cerulean’s President & Chief Executive Officer. “We believe that CRLX101 can help women living with ovarian cancer, especially when used in combinations with other cancer treatments. We are currently studying CRLX101 in combination with Avastin® in another trial of women with relapsed ovarian cancer, and now we have begun studying CRLX101 in combination with weekly paclitaxel in the same setting. We appreciate our collaboration with the GOG Foundation on this important new study.”
Paclitaxel, a widely used chemotherapy used as subsequent therapy for the treatment of advanced ovarian cancer, has anti-angiogenic properties which can induce hypoxic conditions, leading to the up-regulation of hypoxia inducible factor 1α, or HIF-1α, causing tumors to develop drug resistance. Preclinical data demonstrate that CRLX101 reduces the up-regulation of HIF-1α, and may sensitize tumors that have become resistant to previous therapy.
This Phase 1b multi-center, open-label, dose-escalation study combines CRLX101 with weekly paclitaxel in up to 18 patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer. The trial is designed to identify the maximum tolerated dose as well as pharmacokinetics, safety and tolerability of CRLX101 in combination with weekly paclitaxel. Preliminary evidence of efficacy will also be evaluated.
About GOG Foundation, Inc.
The GOG Foundation, Inc. (GOG Foundation) is an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of its processes is utilized in order to constantly improve the quality of patient care. The GOG Foundation conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva. The GOG Foundation is a separate entity from the National Clinical Trials Network groups that are funded by the National Cancer Institute.
About CRLX101
CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication, and also inhibits hypoxia-inducible factor-1α (HIF-1α), which research suggests is a master regulator of cancer cell survival mechanisms. CRLX101 has shown activity in four different tumor types, both as monotherapy and in combination with other cancer treatments. CRLX101 is in Phase 2 clinical development and has been dosed in more than 250 patients. The U.S. FDA has granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.
About CRLX301
CRLX301 is a dynamically tumor-targeted NDC designed to concentrate in tumors and slowly release its anti-cancer payload, docetaxel, inside tumor cells. In preclinical studies, CRLX301 delivers up to 10 times more docetaxel into tumors, compared to an equivalent milligram dose of commercially available docetaxel and was superior to docetaxel in seven of seven animal models, with a statistically significant survival benefit seen in five of those seven models. In addition, preclinical data show that CRLX301 had lower toxicity than has been reported with docetaxel in similar preclinical studies. CRLX301 is currently in Phase 1 clinical development.
About Cerulean Pharma
The Cerulean team is committed to improving treatment for people living with cancer. We apply our Dynamic Tumor Targeting Platform to create a portfolio of NDCs designed to selectively attack tumor cells, reduce toxicity by sparing the body’s normal cells, and enable therapeutic combinations. Our first platform-generated candidate, CRLX101, is in multiple clinical trials in combination with other cancer treatments, all of which aim to unlock the power of combination therapy. Our second platform-generated candidate, CRLX301, is in a Phase 1/2a clinical trial. For more information, please visit www.ceruleanrx.com.
About Cerulean’s Dynamic Tumor Targeting™ Platform
Cerulean’s Dynamic Tumor Targeting Platform creates NDCs that are designed to provide safer and more effective cancer treatments. We believe our NDCs concentrate their anti-cancer payloads inside tumors while sparing normal tissue because they are small enough to pass through the “leaky” vasculature present in tumors but are too large to pass through the wall of healthy blood vessels. Once inside tumors, our NDCs enter tumor cells where they slowly release anti-cancer payloads from within the tumor cells.
SOURCE: Cerulean Pharma
Post Views: 163
Trial is being conducted in collaboration with the GOG Foundation
CAMBRIDGE, MA, USA I July 21 2015 I Cerulean Pharma Inc. (Nasdaq: CERU) today announced that the first patient has been dosed in an open label Phase 1b clinical trial of its lead product candidate, CRLX101, in combination with weekly paclitaxel in patients with relapsed ovarian cancer by the University of Virginia School of Medicine. This trial is being conducted by Cerulean in collaboration with the GOG Foundation under the direction of principal investigator, Carolyn N. Krasner, M.D., of the Massachusetts General Hospital Cancer Center.
“Relapsed ovarian cancer is an area of high unmet medical need,” said Chris Guiffre, Cerulean’s President & Chief Executive Officer. “We believe that CRLX101 can help women living with ovarian cancer, especially when used in combinations with other cancer treatments. We are currently studying CRLX101 in combination with Avastin® in another trial of women with relapsed ovarian cancer, and now we have begun studying CRLX101 in combination with weekly paclitaxel in the same setting. We appreciate our collaboration with the GOG Foundation on this important new study.”
Paclitaxel, a widely used chemotherapy used as subsequent therapy for the treatment of advanced ovarian cancer, has anti-angiogenic properties which can induce hypoxic conditions, leading to the up-regulation of hypoxia inducible factor 1α, or HIF-1α, causing tumors to develop drug resistance. Preclinical data demonstrate that CRLX101 reduces the up-regulation of HIF-1α, and may sensitize tumors that have become resistant to previous therapy.
This Phase 1b multi-center, open-label, dose-escalation study combines CRLX101 with weekly paclitaxel in up to 18 patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer. The trial is designed to identify the maximum tolerated dose as well as pharmacokinetics, safety and tolerability of CRLX101 in combination with weekly paclitaxel. Preliminary evidence of efficacy will also be evaluated.
About GOG Foundation, Inc.
The GOG Foundation, Inc. (GOG Foundation) is an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of its processes is utilized in order to constantly improve the quality of patient care. The GOG Foundation conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva. The GOG Foundation is a separate entity from the National Clinical Trials Network groups that are funded by the National Cancer Institute.
About CRLX101
CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication, and also inhibits hypoxia-inducible factor-1α (HIF-1α), which research suggests is a master regulator of cancer cell survival mechanisms. CRLX101 has shown activity in four different tumor types, both as monotherapy and in combination with other cancer treatments. CRLX101 is in Phase 2 clinical development and has been dosed in more than 250 patients. The U.S. FDA has granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.
About CRLX301
CRLX301 is a dynamically tumor-targeted NDC designed to concentrate in tumors and slowly release its anti-cancer payload, docetaxel, inside tumor cells. In preclinical studies, CRLX301 delivers up to 10 times more docetaxel into tumors, compared to an equivalent milligram dose of commercially available docetaxel and was superior to docetaxel in seven of seven animal models, with a statistically significant survival benefit seen in five of those seven models. In addition, preclinical data show that CRLX301 had lower toxicity than has been reported with docetaxel in similar preclinical studies. CRLX301 is currently in Phase 1 clinical development.
About Cerulean Pharma
The Cerulean team is committed to improving treatment for people living with cancer. We apply our Dynamic Tumor Targeting Platform to create a portfolio of NDCs designed to selectively attack tumor cells, reduce toxicity by sparing the body’s normal cells, and enable therapeutic combinations. Our first platform-generated candidate, CRLX101, is in multiple clinical trials in combination with other cancer treatments, all of which aim to unlock the power of combination therapy. Our second platform-generated candidate, CRLX301, is in a Phase 1/2a clinical trial. For more information, please visit www.ceruleanrx.com.
About Cerulean’s Dynamic Tumor Targeting™ Platform
Cerulean’s Dynamic Tumor Targeting Platform creates NDCs that are designed to provide safer and more effective cancer treatments. We believe our NDCs concentrate their anti-cancer payloads inside tumors while sparing normal tissue because they are small enough to pass through the “leaky” vasculature present in tumors but are too large to pass through the wall of healthy blood vessels. Once inside tumors, our NDCs enter tumor cells where they slowly release anti-cancer payloads from within the tumor cells.
SOURCE: Cerulean Pharma
Post Views: 163
