WEST LAFAYETTE, IN, USA I January 24, 2014 I Endocyte, Inc. (ECYT), a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today provided an update regarding the review of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on the pending EU conditional marketing authorization applications for vintafolide, etarfolatide and intravenous (IV) folic acid.
“Following the discussion of our marketing applications this week, the CHMP has confirmed the questions they would like us to address, including during an oral explanation at an upcoming meeting,” said Ron Ellis, CEO and president of Endocyte. “It is our expectation that the oral explanation will occur in the first quarter, and if we are able to address those questions completely, an opinion from the CHMP could be rendered at the following monthly meeting.”
The submissions for vintafolide in combination with pegylated liposomal doxorubicin (PLD) for the treatment of adult patients with folate receptor-positive, platinum-resistant ovarian cancer and for the companion diagnostic imaging agent, etarfolatide, are currently under review for a conditional marketing authorization application with the EMA.
About Vintafolide (MK-8109/EC145)
Vintafolide is an investigational proprietary, injectable, SMDC consisting of folate (vitamin B9) linked to a potent vinca alkaloid chemotherapy agent, desacetylvinblastine hydrazide (DAVLBH). Vintafolide is designed to target the chemotherapy agent to rapidly growing cancer cells that actively take up folate via the folate receptor. The folate receptor is expressed in a wide variety of cancers including ovarian cancer.
Vintafolide (MK-8109/EC145) in combination with pegylated liposomal doxorubicin (PLD) is currently under review with the European Medicines Agency (EMA) for the treatment of adult patients with folate receptor-positive platinum-resistant ovarian cancer. Vintafolide has also been granted orphan drug status by the European Commission. Vintafolide, along with investigational companion imaging agent, etarfolatide, is currently being evaluated in a Phase 3 clinical trial for platinum-resistant ovarian cancer, (PROCEED trial; ClinicalTrials.gov Identifier NCT01170650) and a Phase 2b trial for non-small cell lung cancer (NSCLC) (TARGET trial; ClinicalTrials.gov Identifier NCT01577654). A Phase 2 randomized trial of vintafolide in folate receptor-positive triple negative breast cancer is expected to be initiated in the near future.
As part of an exclusive license agreement with Endocyte, Merck is responsible for the development and worldwide commercialization of vintafolide. Endocyte would intend to co-promote vintafolide in the U.S. pending regulatory filing and approval, and is responsible for the development, manufacture and commercialization of etarfolatide worldwide.
About Etarfolatide (EC20)
Etarfolatide is an investigational folate receptor-targeted companion imaging agent that is being developed as a non-invasive method to identify tumors that express the folate receptor. These tumors are the molecular target of Endocyte’s folate receptor-targeted therapeutic compounds such as vintafolide and EC1456. Folic acid is used with etarfolatide for the enhancement of image quality. Etarfolatide is under review with the EMA and has been granted orphan drug status by the European Commission.
About Endocyte
Endocyte is a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging agents for personalized targeted therapies. The company’s SMDCs actively target receptors that are expressed or over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly potent drugs into these cells. The companion imaging agents are designed to identify patients whose disease expresses the molecular target of the therapy and who therefore may be more likely to benefit from treatment. For more information, visit http://www.endocyte.com.
SOURCE: Endocyte
Post Views: 128
WEST LAFAYETTE, IN, USA I January 24, 2014 I Endocyte, Inc. (ECYT), a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases, today provided an update regarding the review of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on the pending EU conditional marketing authorization applications for vintafolide, etarfolatide and intravenous (IV) folic acid.
“Following the discussion of our marketing applications this week, the CHMP has confirmed the questions they would like us to address, including during an oral explanation at an upcoming meeting,” said Ron Ellis, CEO and president of Endocyte. “It is our expectation that the oral explanation will occur in the first quarter, and if we are able to address those questions completely, an opinion from the CHMP could be rendered at the following monthly meeting.”
The submissions for vintafolide in combination with pegylated liposomal doxorubicin (PLD) for the treatment of adult patients with folate receptor-positive, platinum-resistant ovarian cancer and for the companion diagnostic imaging agent, etarfolatide, are currently under review for a conditional marketing authorization application with the EMA.
About Vintafolide (MK-8109/EC145)
Vintafolide is an investigational proprietary, injectable, SMDC consisting of folate (vitamin B9) linked to a potent vinca alkaloid chemotherapy agent, desacetylvinblastine hydrazide (DAVLBH). Vintafolide is designed to target the chemotherapy agent to rapidly growing cancer cells that actively take up folate via the folate receptor. The folate receptor is expressed in a wide variety of cancers including ovarian cancer.
Vintafolide (MK-8109/EC145) in combination with pegylated liposomal doxorubicin (PLD) is currently under review with the European Medicines Agency (EMA) for the treatment of adult patients with folate receptor-positive platinum-resistant ovarian cancer. Vintafolide has also been granted orphan drug status by the European Commission. Vintafolide, along with investigational companion imaging agent, etarfolatide, is currently being evaluated in a Phase 3 clinical trial for platinum-resistant ovarian cancer, (PROCEED trial; ClinicalTrials.gov Identifier NCT01170650) and a Phase 2b trial for non-small cell lung cancer (NSCLC) (TARGET trial; ClinicalTrials.gov Identifier NCT01577654). A Phase 2 randomized trial of vintafolide in folate receptor-positive triple negative breast cancer is expected to be initiated in the near future.
As part of an exclusive license agreement with Endocyte, Merck is responsible for the development and worldwide commercialization of vintafolide. Endocyte would intend to co-promote vintafolide in the U.S. pending regulatory filing and approval, and is responsible for the development, manufacture and commercialization of etarfolatide worldwide.
About Etarfolatide (EC20)
Etarfolatide is an investigational folate receptor-targeted companion imaging agent that is being developed as a non-invasive method to identify tumors that express the folate receptor. These tumors are the molecular target of Endocyte’s folate receptor-targeted therapeutic compounds such as vintafolide and EC1456. Folic acid is used with etarfolatide for the enhancement of image quality. Etarfolatide is under review with the EMA and has been granted orphan drug status by the European Commission.
About Endocyte
Endocyte is a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy in cancer and other serious diseases. Endocyte uses its proprietary technology to create novel SMDCs and companion imaging agents for personalized targeted therapies. The company’s SMDCs actively target receptors that are expressed or over-expressed on diseased cells, relative to healthy cells. This targeted approach is designed to enable the treatment of patients with highly potent drugs into these cells. The companion imaging agents are designed to identify patients whose disease expresses the molecular target of the therapy and who therefore may be more likely to benefit from treatment. For more information, visit http://www.endocyte.com.
SOURCE: Endocyte
Post Views: 128
