TORONTO, Canada & SAN DIEGO, CA, USA I September 26, 2015 I Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, today announced preliminary results of a Phase 1 dose-escalation study of marizomib in combination with pomalidomide (POM) and low dose dexamethasone (Lo-DEX) in patients with relapsed and refractory multiple myeloma. The marizomib/POM/Lo-DEX combination was able to decrease myeloma proteins by at least 50 percent to achieve an overall response rate of 62 percent in a patient population that was refractory to multiple prior therapies. Marizomib, a novel and highly potent pan-proteasome inhibitor, POM and DEX were generally well tolerated, with no dose-limiting toxicities observed at the four dose levels tested. The study was one of only six studies highlighted during a special plenary session at the International Myeloma Society’s 15th International Myeloma Workshop in Rome, Italy.
“Nearly all patients with relapsed and refractory multiple myeloma will eventually relapse on currently available therapies, underscoring the importance of developing new treatment options,” said Professor Andrew Spencer, lead author, Head of the Malignant Hematology & Stem Cell Transplantation Service at The Alfred Hospital and Professor of Hematology at Monash University in Melbourne, Australia. “Marizomib does not appear to add toxicity to the established POM/DEX safety profile, and the combination of drugs demonstrated encouraging activity in some of the sickest patients with multiple myeloma. I believe that this combination of drugs holds great promise for the treatment of multiple myeloma.”
“We are encouraged by the results of this Phase 1 study and are working diligently with our clinical sites and Celgene Corporation to accelerate the clinical development of marizomib,” said Mohit Trikha, Ph.D., Chief Scientific Officer and Head of R&D at Triphase Accelerator. “Now that the dose-escalation stage of the study has been completed, we are enrolling patients in a larger dose-expansion stage to select the dosing regimen for larger-scale clinical studies.”
Study Design and Key Results
The multicenter, open-label, dose-escalation study evaluated the combination of intravenous marizomib plus oral POM and Lo-DEX in patients with relapsed and refractory multiple myeloma. All patients had received at least two prior myeloma therapies, which must have included the approved myeloma drugs, lenalidomide and bortezomib, and the patients must have been refractory to their last myeloma therapy. The study was conducted at the Dana Farber Cancer Institute in Boston, the University of Maryland Medical Center in Baltimore, the Karmanos Cancer Center in Detroit, and the Peter MacCallum Cancer Centre and the Alfred Hospital in Australia. The Multiple Myeloma Research Consortium also supported this research.
Results for the 13 patients evaluable for response included 8 (62 percent) with a partial response, 2 (15 percent) with a minimal response, and 3 (23 percent) with stable disease. All of the patients had a decrease in their myeloma protein by the end of the first treatment cycle. The most common Grade 3 (severe) adverse events related to at least one of the study treatments were neutropenia, anemia and thrombocytopenia.
About Marizomib
Marizomib is a novel and highly potent proteasome inhibitor that irreversibly binds and inhibits all three proteasome subunits, which translates into longer duration of effect and potentially improved clinical activity. Triphase Accelerator is developing marizomib in both intravenous and oral formulations as a potential best-in-class proteasome inhibitor for hematologic malignancies and solid tumors. The IV formulation has been evaluated in more than 270 patients in six clinical studies in patients with solid and hematologic malignancies, either as a single agent or in combination with dexamethasone, a histone deacetylase inhibitor, or an immunomodulatory drug.
Triphase Accelerator is currently evaluating marizomib in a Phase 1 proof-of-concept clinical study in combination with bevacizumab (Avastin®) in patients with Grade IV malignant glioma (glioblastoma). Triphase Accelerator is also evaluating an oral formulation in preclinical studies. The Company has received Orphan Drug designation for marizomib in multiple myeloma in the United States and the European Union.
About Triphase Accelerator
Triphase Accelerator is a private drug development company with a primary focus on oncology and with operations in Toronto and San Diego. Triphase Accelerator is dedicated to advancing novel compounds through Phase 2 proof-of-concept clinical studies using a unique, science-based, high-quality model that is faster and more cost-effective than traditional pharmaceutical and biotech industry drug development approaches. Triphase Accelerator was spun out of the Ontario Institute for Cancer Research (OICR), with support from the Fight Against Cancer Innovation Trust (FACIT), MaRS Innovation and MaRS. It has a strategic relationship with Celgene for oncology-focused drug development opportunities. For more information, visit www.triphaseco.com or Linkedin.
SOURCE: Triphase Accelerator
Post Views: 42
TORONTO, Canada & SAN DIEGO, CA, USA I September 26, 2015 I Triphase Accelerator Corporation, a private drug development company dedicated to advancing novel compounds through Phase 2 proof-of-concept, today announced preliminary results of a Phase 1 dose-escalation study of marizomib in combination with pomalidomide (POM) and low dose dexamethasone (Lo-DEX) in patients with relapsed and refractory multiple myeloma. The marizomib/POM/Lo-DEX combination was able to decrease myeloma proteins by at least 50 percent to achieve an overall response rate of 62 percent in a patient population that was refractory to multiple prior therapies. Marizomib, a novel and highly potent pan-proteasome inhibitor, POM and DEX were generally well tolerated, with no dose-limiting toxicities observed at the four dose levels tested. The study was one of only six studies highlighted during a special plenary session at the International Myeloma Society’s 15th International Myeloma Workshop in Rome, Italy.
“Nearly all patients with relapsed and refractory multiple myeloma will eventually relapse on currently available therapies, underscoring the importance of developing new treatment options,” said Professor Andrew Spencer, lead author, Head of the Malignant Hematology & Stem Cell Transplantation Service at The Alfred Hospital and Professor of Hematology at Monash University in Melbourne, Australia. “Marizomib does not appear to add toxicity to the established POM/DEX safety profile, and the combination of drugs demonstrated encouraging activity in some of the sickest patients with multiple myeloma. I believe that this combination of drugs holds great promise for the treatment of multiple myeloma.”
“We are encouraged by the results of this Phase 1 study and are working diligently with our clinical sites and Celgene Corporation to accelerate the clinical development of marizomib,” said Mohit Trikha, Ph.D., Chief Scientific Officer and Head of R&D at Triphase Accelerator. “Now that the dose-escalation stage of the study has been completed, we are enrolling patients in a larger dose-expansion stage to select the dosing regimen for larger-scale clinical studies.”
Study Design and Key Results
The multicenter, open-label, dose-escalation study evaluated the combination of intravenous marizomib plus oral POM and Lo-DEX in patients with relapsed and refractory multiple myeloma. All patients had received at least two prior myeloma therapies, which must have included the approved myeloma drugs, lenalidomide and bortezomib, and the patients must have been refractory to their last myeloma therapy. The study was conducted at the Dana Farber Cancer Institute in Boston, the University of Maryland Medical Center in Baltimore, the Karmanos Cancer Center in Detroit, and the Peter MacCallum Cancer Centre and the Alfred Hospital in Australia. The Multiple Myeloma Research Consortium also supported this research.
Results for the 13 patients evaluable for response included 8 (62 percent) with a partial response, 2 (15 percent) with a minimal response, and 3 (23 percent) with stable disease. All of the patients had a decrease in their myeloma protein by the end of the first treatment cycle. The most common Grade 3 (severe) adverse events related to at least one of the study treatments were neutropenia, anemia and thrombocytopenia.
About Marizomib
Marizomib is a novel and highly potent proteasome inhibitor that irreversibly binds and inhibits all three proteasome subunits, which translates into longer duration of effect and potentially improved clinical activity. Triphase Accelerator is developing marizomib in both intravenous and oral formulations as a potential best-in-class proteasome inhibitor for hematologic malignancies and solid tumors. The IV formulation has been evaluated in more than 270 patients in six clinical studies in patients with solid and hematologic malignancies, either as a single agent or in combination with dexamethasone, a histone deacetylase inhibitor, or an immunomodulatory drug.
Triphase Accelerator is currently evaluating marizomib in a Phase 1 proof-of-concept clinical study in combination with bevacizumab (Avastin®) in patients with Grade IV malignant glioma (glioblastoma). Triphase Accelerator is also evaluating an oral formulation in preclinical studies. The Company has received Orphan Drug designation for marizomib in multiple myeloma in the United States and the European Union.
About Triphase Accelerator
Triphase Accelerator is a private drug development company with a primary focus on oncology and with operations in Toronto and San Diego. Triphase Accelerator is dedicated to advancing novel compounds through Phase 2 proof-of-concept clinical studies using a unique, science-based, high-quality model that is faster and more cost-effective than traditional pharmaceutical and biotech industry drug development approaches. Triphase Accelerator was spun out of the Ontario Institute for Cancer Research (OICR), with support from the Fight Against Cancer Innovation Trust (FACIT), MaRS Innovation and MaRS. It has a strategic relationship with Celgene for oncology-focused drug development opportunities. For more information, visit www.triphaseco.com or Linkedin.
SOURCE: Triphase Accelerator
Post Views: 42
