Hackensack, NJ, United States
Hackensack, NJ, United States

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Avivi I.,Tel Aviv Medical Center | Goy A.,John Theurer Cancer Center
Clinical Cancer Research | Year: 2015

Although mantle cell lymphoma (MCL) is a rare subtype of non-Hodgkin lymphoma, proactive research efforts fueled by challenges in the management of MCL have led to an increase in median overall survival (OS) of 2.5 years in the mid 1990s to beyond 5 years nowadays. This improvement is due mostly to the use of dose-intensive strategies, particularly cytarabine-containing regimens [with or without high-dose therapy (HDT) followed by autologous stem cell transplantation (ASCT) consolidation], which are associated with deeper remission (and higher molecular complete response rate), as well as better salvage therapies. Along this line, MCL became the first lymphoma for which four novel agents have been approved in the relapsed/refractory setting: temsirolimus, lenalidomide, ibrutinib, and bortezomib (the last agent approved both in relapsed/refractory disease and in first-line combination therapy). In addition, the use of rituximab maintenance has helped reduce relapse rates and improve outcome. However, in routine practice (i.e., outside clinical trials), the outcome of MCL remains overall unchanged with standard immunochemotherapy, and even after HDT-ASCT, most patients still relapse and frequently develop chemoresistance. The persistent lack of consensus for the treatment of MCL explains the rather impressive variability in management of these patients. The integration of newer therapies, either in combination with immunochemotherapy or as consolidation/maintenance postinduction, offers new opportunities for patients with MCL. This review highlights how such developments can help refine the current MCL paradigm. © 2015 American Association for Cancer Research.


News Article | December 5, 2016
Site: www.prweb.com

Physicians Education Resource®, LLC (PER®) announces Amy E. Herman as Keynote speaker for the 21st Annual International Congress on Hematologic Malignancies®: Focus on Leukemias, Lymphomas, and Myeloma, on February 24, 2017. In making the announcement, PER® president, Phil Talamo said, “We are honored to have Amy E. Herman present at this year’s conference, her unprecedented knowledge conducting leadership training will provide attendees with added expertise to lead future medical teams, which is vital to improving the lives of cancer patients in such a fast-moving field.” With over 14 years of experience, Herman is the founder and president of The Art of Perception, Inc., and a leading expert in professional development, training some of the most influential industry leaders around the world, including the FBI, CIA, Scotland Yard, and the Peace Corps. Prior to this, Herman was the director of the educational development for the public television station, serving New Jersey and New York, Thirteen/WNET. In addition, the co-chairs for this year’s conference are Andre Goy, MD, MS, and Sagar Lonial, MD, FACP. Dr. Goy is the chairman and director of the John Theurer Cancer Center and the chief of the division of lymphoma. Dr. Lonial is the chief medical officer for the Winship Cancer Institute of Emory University and a board-certified hematologist and medical oncologist. The 21st Annual International Congress on Hematologic Malignancies®: Focus on Leukemias, Lymphomas and Myeloma is a three-day educational symposium from February 23rd-25th at the Trump International Miami. To register for the symposium, visit: http://www.gotoper.com About PER® Since 1995, PER® has been the educational resource of choice for live and online activities focusing on oncology and hematology. PER® provides high-quality, evidence-based activities featuring leading national and international faculty with a focus on practice-changing advances and standards of care in treatment and disease management. Activities also include topics on emerging strategies currently under investigation, supportive care, diagnosis and staging, prevention, screening and early detection, and practice management. With the rapid advances occurring in the field of oncology, understanding how to use molecular data to diagnose and stage patients, selecting the most appropriate candidates for novel therapeutic agents, individualizing treatment based on tumor type, and referring patients to clinical trials will continue to ensure the highest level of patient care is provided. PER® serves the oncology health care community, including physicians, fellows, advanced practice nurses, nurses, physician assistants, pharmacists, and researchers. PER® is part of the Plainsboro, N.J.-based Michael J. Hennessy Associates, Inc. family of businesses. Learn more at http://www.gotoper.com and http://www.mjhassoc.com


News Article | February 15, 2017
Site: www.prweb.com

Physicians’ Education Resource®, (PER®), will host the 21st Annual International Congress on Hematologic Malignancies®: Focus on Leukemias, Lymphomas and Myeloma, and the symposium will be co-chaired by Andre Goy — who is professor of medicine, chief of lymphoma and director at John Theurer Cancer Center, chair of oncology for Hackensack Meridian Health Network in Hackensack, New Jersey — and Sager Lonial, who is a professor and chair of the Department of Hematology and Medical Oncology at Emory School of Medicine, chief medical officer of the Winship Cancer Institute of Emory University in Atlanta, Georgia. “We are in the midst of unprecedented changes in medicine particularly in oncology,” said Goy. “Symposiums such as Miami Hematology, offer an opportunity for each attendee to share directly with world experts how such changes can truly reshape patients’ care.” The 21st Annual International Congress on Hematologic Malignancies®: Focus on Leukemias, Lymphomas and Myeloma is designed to facilitate application of the rapid changes seen in oncology while treating hematological malignancies. As health care continues to rapidly evolve, it becomes critical not only to be able to choose the best option for each patient precision medicine but also in an era with so many options available— to appreciate the best sequence of therapies to optimize outcome. This will be addressed throughout the three-day-conference during the well-known and highly interactive Medical Crossfire® discussion panels and real-world case discussions. In addition, Amy E. Herman, will speak on “The Art of Perception and its Connection to the Art of Clinical Medicine.” Herman is a leading expert in professional development, training some of the most influential industry leaders around the world, including the FBI, CIA, Scotland Yard and the Peace Corps. Previously, Herman was the director of the educational development for Thirteen/WNET, the public television station, serving New Jersey and New York. The three-day symposium will be held at the Trump International Miami on Feb.23-25 in Sunny Isles Beach, Florida, located 3.5 miles from the Miami International Airport and 13 miles from the Fort Lauderdale International Airport. About PER® Since 1995, PER® has been the educational resource of choice for live and online activities focusing on oncology and hematology. PER® provides high-quality, evidence-based activities featuring leading national and international faculty with a focus on practice-changing advances and standards of care in treatment and disease management. Activities also include topics on emerging strategies currently under investigation, supportive care, diagnosis and staging, prevention, screening and early detection, and practice management. With the rapid advances occurring in the field of oncology, understanding how to use molecular data to diagnose and stage patients, selecting the most appropriate candidates for novel therapeutic agents, individualizing treatment based on tumor type, and referring patients to clinical trials will continue to ensure the highest level of patient care is provided. PER® serves the oncology health care community, including physicians, fellows, advanced practice nurses, nurses, physician assistants, pharmacists, and researchers. PER® is part of the Cranbury, N.J.-based Michael J. Hennessy Associates, Inc. family of businesses. Learn more at http://www.gotoper.com and http://www.mjhassoc.com


–  Median overall survival improved to 13.4 from 12.9 months after extended follow-up  – –  64% of patients alive after one year compared to historical rates of 25-38%   – SCOTTSDALE, Ariz., Nov. 18, 2016 (GLOBE NEWSWIRE) -- Cortice Biosciences announced today follow-up results from CB-017, a Phase 1/2 clinical trial evaluating TPI 287 plus bevacizumab (Avastin®) in patients with recurrent glioblastoma (GBM) who have not received prior bevacizumab.  These results will be presented this evening during a poster session at the 21st Annual Scientific Meeting of the Society of Neuro-Oncology. TPI 287 is a novel microtubule stabilizing agent that readily penetrates the blood-brain barrier.  Prior preclinical and clinical results support the potential of this agent for the treatment of aggressive brain cancers in patients with few therapeutic options. “Results from our TPI 287 development program continue to support meaningful drug activity in GBM,” said George Farmer, Ph.D., Chief Executive Officer of Cortice.  “Compared to overall survival rates observed in other multi-center clinical trials enrolling similar GBM populations, outcomes of CB-017 are very encouraging.  We look forward to continued development of TPI 287 for treatment of GBM and presenting final results from the Phase 1 portion of CB-017 at another medical meeting next year.” Twenty-four patients with recurrent GBM that had progressed beyond first line treatment and who had not received prior bevacizumab were enrolled in the dose-escalation portion of CB-017.  In addition to TPI 287 (140 to 220 mg/m2 administered every three weeks in seven dose cohorts), all patients received standard-of-care bevacizumab (10 mg/kg every two weeks).  Twenty and 23 patients were evaluable for overall response and overall survival, respectively. Key efficacy metrics are as follows: Safety data available from 22 patients enrolled in CB-017 supports the favorable tolerability profile of TPI 287.  With the exception of Grade 3 myelosuppression (3 patients), all adverse events regarded as possibly related to TPI 287 have been mild to moderate.  No dose limiting toxicities (DLTs) have been observed to date. Based on observations from CB-017 so far, an optimal dose of TPI 287 has been selected for the expansion stage of the trial.  Following guidance provided by FDA, results from this study will inform the design of a single Phase 3 registration trial for TPI 287 in GBM. “The improvement in median overall survival to 13.4 from 12.9 months appears to be driven by outcomes in patients treated at the higher doses of this study,” said Dr. Samuel Goldlust, Medical Director of the Brain and Spine Institute of the John Theurer Cancer Center in Hackensack, NJ and Principal Investigator of CB-017. “This positive survival trend and the excellent tolerability of TPI 287 observed in the study to date support continued investigation in recurrent glioblastoma, an indication in desperate need of new therapies.” TPI 287 is a novel taxoid which binds to and stabilizes the assembly of microtubules similarly to commonly used taxanes, including paclitaxel (Taxol® and Abraxane®) and docetaxel (Taxotere®).  In oncology treatment settings, microtubule stabilization by these agents leads to mitotic arrest and cancer cell death.  TPI 287 has advantages over these taxanes for the treatment of brain cancers due to its ability to penetrate the central nervous system, which is often shielded from systemic administration of other anti-cancer drugs. Microtubule stabilization by TPI 287 may also have potential for the treatment of neurologic disorders affected by tau protein pathology.  These include tauopathies such as Alzheimer’s disease and orphan diseases, such as progressive supranuclear palsy, corticobasal degeneration, and frontotemporal dementia. Glioblastoma (GBM) is the most aggressive and common form of brain cancer.  Five-year survival after diagnosis is about 5%.  The Central Brain Tumor Registry estimates that about 24,790 primary malignant brain tumors cases will be diagnosed in the US in 2016, 46% of which will be GBM.  Typical front-line treatments include stereotactic or whole brain radiotherapy plus temozolomide (Temodar®).  Patients with recurrent disease are candidates for treatment with Avastin®, the last drug approved by FDA for this disease. Cortice Biosciences, Inc. is a clinical-stage drug development company developing novel therapies for oncologic and neurologic disease indications with urgent unmet medical need.  More information can be found at www.corticebiosciences.com. This media release may contain forward-looking statements about Cortice Biosciences, which can be identified by the use of terminology such as "will," "would," "should," "expects," "anticipates," "intends," "plans," "believes," "may," "estimates," "predicts," "projects,” or similar expressions intended to identify such statements.  These statements reflect the current views of Cortice with respect to future events, are based on assumptions, and subject to risks and uncertainties.


–  Median overall survival improved to 13.4 from 12.9 months after extended follow-up  – –  64% of patients alive after one year compared to historical rates of 25-38%   – SCOTTSDALE, Ariz., Nov. 18, 2016 (GLOBE NEWSWIRE) -- Cortice Biosciences announced today follow-up results from CB-017, a Phase 1/2 clinical trial evaluating TPI 287 plus bevacizumab (Avastin®) in patients with recurrent glioblastoma (GBM) who have not received prior bevacizumab.  These results will be presented this evening during a poster session at the 21st Annual Scientific Meeting of the Society of Neuro-Oncology. TPI 287 is a novel microtubule stabilizing agent that readily penetrates the blood-brain barrier.  Prior preclinical and clinical results support the potential of this agent for the treatment of aggressive brain cancers in patients with few therapeutic options. “Results from our TPI 287 development program continue to support meaningful drug activity in GBM,” said George Farmer, Ph.D., Chief Executive Officer of Cortice.  “Compared to overall survival rates observed in other multi-center clinical trials enrolling similar GBM populations, outcomes of CB-017 are very encouraging.  We look forward to continued development of TPI 287 for treatment of GBM and presenting final results from the Phase 1 portion of CB-017 at another medical meeting next year.” Twenty-four patients with recurrent GBM that had progressed beyond first line treatment and who had not received prior bevacizumab were enrolled in the dose-escalation portion of CB-017.  In addition to TPI 287 (140 to 220 mg/m2 administered every three weeks in seven dose cohorts), all patients received standard-of-care bevacizumab (10 mg/kg every two weeks).  Twenty and 23 patients were evaluable for overall response and overall survival, respectively. Key efficacy metrics are as follows: Safety data available from 22 patients enrolled in CB-017 supports the favorable tolerability profile of TPI 287.  With the exception of Grade 3 myelosuppression (3 patients), all adverse events regarded as possibly related to TPI 287 have been mild to moderate.  No dose limiting toxicities (DLTs) have been observed to date. Based on observations from CB-017 so far, an optimal dose of TPI 287 has been selected for the expansion stage of the trial.  Following guidance provided by FDA, results from this study will inform the design of a single Phase 3 registration trial for TPI 287 in GBM. “The improvement in median overall survival to 13.4 from 12.9 months appears to be driven by outcomes in patients treated at the higher doses of this study,” said Dr. Samuel Goldlust, Medical Director of the Brain and Spine Institute of the John Theurer Cancer Center in Hackensack, NJ and Principal Investigator of CB-017. “This positive survival trend and the excellent tolerability of TPI 287 observed in the study to date support continued investigation in recurrent glioblastoma, an indication in desperate need of new therapies.” TPI 287 is a novel taxoid which binds to and stabilizes the assembly of microtubules similarly to commonly used taxanes, including paclitaxel (Taxol® and Abraxane®) and docetaxel (Taxotere®).  In oncology treatment settings, microtubule stabilization by these agents leads to mitotic arrest and cancer cell death.  TPI 287 has advantages over these taxanes for the treatment of brain cancers due to its ability to penetrate the central nervous system, which is often shielded from systemic administration of other anti-cancer drugs. Microtubule stabilization by TPI 287 may also have potential for the treatment of neurologic disorders affected by tau protein pathology.  These include tauopathies such as Alzheimer’s disease and orphan diseases, such as progressive supranuclear palsy, corticobasal degeneration, and frontotemporal dementia. Glioblastoma (GBM) is the most aggressive and common form of brain cancer.  Five-year survival after diagnosis is about 5%.  The Central Brain Tumor Registry estimates that about 24,790 primary malignant brain tumors cases will be diagnosed in the US in 2016, 46% of which will be GBM.  Typical front-line treatments include stereotactic or whole brain radiotherapy plus temozolomide (Temodar®).  Patients with recurrent disease are candidates for treatment with Avastin®, the last drug approved by FDA for this disease. Cortice Biosciences, Inc. is a clinical-stage drug development company developing novel therapies for oncologic and neurologic disease indications with urgent unmet medical need.  More information can be found at www.corticebiosciences.com. This media release may contain forward-looking statements about Cortice Biosciences, which can be identified by the use of terminology such as "will," "would," "should," "expects," "anticipates," "intends," "plans," "believes," "may," "estimates," "predicts," "projects,” or similar expressions intended to identify such statements.  These statements reflect the current views of Cortice with respect to future events, are based on assumptions, and subject to risks and uncertainties.


–  Median overall survival improved to 13.4 from 12.9 months after extended follow-up  – –  64% of patients alive after one year compared to historical rates of 25-38%   – SCOTTSDALE, Ariz., Nov. 18, 2016 (GLOBE NEWSWIRE) -- Cortice Biosciences announced today follow-up results from CB-017, a Phase 1/2 clinical trial evaluating TPI 287 plus bevacizumab (Avastin®) in patients with recurrent glioblastoma (GBM) who have not received prior bevacizumab.  These results will be presented this evening during a poster session at the 21st Annual Scientific Meeting of the Society of Neuro-Oncology. TPI 287 is a novel microtubule stabilizing agent that readily penetrates the blood-brain barrier.  Prior preclinical and clinical results support the potential of this agent for the treatment of aggressive brain cancers in patients with few therapeutic options. “Results from our TPI 287 development program continue to support meaningful drug activity in GBM,” said George Farmer, Ph.D., Chief Executive Officer of Cortice.  “Compared to overall survival rates observed in other multi-center clinical trials enrolling similar GBM populations, outcomes of CB-017 are very encouraging.  We look forward to continued development of TPI 287 for treatment of GBM and presenting final results from the Phase 1 portion of CB-017 at another medical meeting next year.” Twenty-four patients with recurrent GBM that had progressed beyond first line treatment and who had not received prior bevacizumab were enrolled in the dose-escalation portion of CB-017.  In addition to TPI 287 (140 to 220 mg/m2 administered every three weeks in seven dose cohorts), all patients received standard-of-care bevacizumab (10 mg/kg every two weeks).  Twenty and 23 patients were evaluable for overall response and overall survival, respectively. Key efficacy metrics are as follows: Safety data available from 22 patients enrolled in CB-017 supports the favorable tolerability profile of TPI 287.  With the exception of Grade 3 myelosuppression (3 patients), all adverse events regarded as possibly related to TPI 287 have been mild to moderate.  No dose limiting toxicities (DLTs) have been observed to date. Based on observations from CB-017 so far, an optimal dose of TPI 287 has been selected for the expansion stage of the trial.  Following guidance provided by FDA, results from this study will inform the design of a single Phase 3 registration trial for TPI 287 in GBM. “The improvement in median overall survival to 13.4 from 12.9 months appears to be driven by outcomes in patients treated at the higher doses of this study,” said Dr. Samuel Goldlust, Medical Director of the Brain and Spine Institute of the John Theurer Cancer Center in Hackensack, NJ and Principal Investigator of CB-017. “This positive survival trend and the excellent tolerability of TPI 287 observed in the study to date support continued investigation in recurrent glioblastoma, an indication in desperate need of new therapies.” TPI 287 is a novel taxoid which binds to and stabilizes the assembly of microtubules similarly to commonly used taxanes, including paclitaxel (Taxol® and Abraxane®) and docetaxel (Taxotere®).  In oncology treatment settings, microtubule stabilization by these agents leads to mitotic arrest and cancer cell death.  TPI 287 has advantages over these taxanes for the treatment of brain cancers due to its ability to penetrate the central nervous system, which is often shielded from systemic administration of other anti-cancer drugs. Microtubule stabilization by TPI 287 may also have potential for the treatment of neurologic disorders affected by tau protein pathology.  These include tauopathies such as Alzheimer’s disease and orphan diseases, such as progressive supranuclear palsy, corticobasal degeneration, and frontotemporal dementia. Glioblastoma (GBM) is the most aggressive and common form of brain cancer.  Five-year survival after diagnosis is about 5%.  The Central Brain Tumor Registry estimates that about 24,790 primary malignant brain tumors cases will be diagnosed in the US in 2016, 46% of which will be GBM.  Typical front-line treatments include stereotactic or whole brain radiotherapy plus temozolomide (Temodar®).  Patients with recurrent disease are candidates for treatment with Avastin®, the last drug approved by FDA for this disease. Cortice Biosciences, Inc. is a clinical-stage drug development company developing novel therapies for oncologic and neurologic disease indications with urgent unmet medical need.  More information can be found at www.corticebiosciences.com. This media release may contain forward-looking statements about Cortice Biosciences, which can be identified by the use of terminology such as "will," "would," "should," "expects," "anticipates," "intends," "plans," "believes," "may," "estimates," "predicts," "projects,” or similar expressions intended to identify such statements.  These statements reflect the current views of Cortice with respect to future events, are based on assumptions, and subject to risks and uncertainties.


–  Median overall survival improved to 13.4 from 12.9 months after extended follow-up  – –  64% of patients alive after one year compared to historical rates of 25-38%   – SCOTTSDALE, Ariz., Nov. 18, 2016 (GLOBE NEWSWIRE) -- Cortice Biosciences announced today follow-up results from CB-017, a Phase 1/2 clinical trial evaluating TPI 287 plus bevacizumab (Avastin®) in patients with recurrent glioblastoma (GBM) who have not received prior bevacizumab.  These results will be presented this evening during a poster session at the 21st Annual Scientific Meeting of the Society of Neuro-Oncology. TPI 287 is a novel microtubule stabilizing agent that readily penetrates the blood-brain barrier.  Prior preclinical and clinical results support the potential of this agent for the treatment of aggressive brain cancers in patients with few therapeutic options. “Results from our TPI 287 development program continue to support meaningful drug activity in GBM,” said George Farmer, Ph.D., Chief Executive Officer of Cortice.  “Compared to overall survival rates observed in other multi-center clinical trials enrolling similar GBM populations, outcomes of CB-017 are very encouraging.  We look forward to continued development of TPI 287 for treatment of GBM and presenting final results from the Phase 1 portion of CB-017 at another medical meeting next year.” Twenty-four patients with recurrent GBM that had progressed beyond first line treatment and who had not received prior bevacizumab were enrolled in the dose-escalation portion of CB-017.  In addition to TPI 287 (140 to 220 mg/m2 administered every three weeks in seven dose cohorts), all patients received standard-of-care bevacizumab (10 mg/kg every two weeks).  Twenty and 23 patients were evaluable for overall response and overall survival, respectively. Key efficacy metrics are as follows: Safety data available from 22 patients enrolled in CB-017 supports the favorable tolerability profile of TPI 287.  With the exception of Grade 3 myelosuppression (3 patients), all adverse events regarded as possibly related to TPI 287 have been mild to moderate.  No dose limiting toxicities (DLTs) have been observed to date. Based on observations from CB-017 so far, an optimal dose of TPI 287 has been selected for the expansion stage of the trial.  Following guidance provided by FDA, results from this study will inform the design of a single Phase 3 registration trial for TPI 287 in GBM. “The improvement in median overall survival to 13.4 from 12.9 months appears to be driven by outcomes in patients treated at the higher doses of this study,” said Dr. Samuel Goldlust, Medical Director of the Brain and Spine Institute of the John Theurer Cancer Center in Hackensack, NJ and Principal Investigator of CB-017. “This positive survival trend and the excellent tolerability of TPI 287 observed in the study to date support continued investigation in recurrent glioblastoma, an indication in desperate need of new therapies.” TPI 287 is a novel taxoid which binds to and stabilizes the assembly of microtubules similarly to commonly used taxanes, including paclitaxel (Taxol® and Abraxane®) and docetaxel (Taxotere®).  In oncology treatment settings, microtubule stabilization by these agents leads to mitotic arrest and cancer cell death.  TPI 287 has advantages over these taxanes for the treatment of brain cancers due to its ability to penetrate the central nervous system, which is often shielded from systemic administration of other anti-cancer drugs. Microtubule stabilization by TPI 287 may also have potential for the treatment of neurologic disorders affected by tau protein pathology.  These include tauopathies such as Alzheimer’s disease and orphan diseases, such as progressive supranuclear palsy, corticobasal degeneration, and frontotemporal dementia. Glioblastoma (GBM) is the most aggressive and common form of brain cancer.  Five-year survival after diagnosis is about 5%.  The Central Brain Tumor Registry estimates that about 24,790 primary malignant brain tumors cases will be diagnosed in the US in 2016, 46% of which will be GBM.  Typical front-line treatments include stereotactic or whole brain radiotherapy plus temozolomide (Temodar®).  Patients with recurrent disease are candidates for treatment with Avastin®, the last drug approved by FDA for this disease. Cortice Biosciences, Inc. is a clinical-stage drug development company developing novel therapies for oncologic and neurologic disease indications with urgent unmet medical need.  More information can be found at www.corticebiosciences.com. This media release may contain forward-looking statements about Cortice Biosciences, which can be identified by the use of terminology such as "will," "would," "should," "expects," "anticipates," "intends," "plans," "believes," "may," "estimates," "predicts," "projects,” or similar expressions intended to identify such statements.  These statements reflect the current views of Cortice with respect to future events, are based on assumptions, and subject to risks and uncertainties.


–  Median overall survival improved to 13.4 from 12.9 months after extended follow-up  – –  64% of patients alive after one year compared to historical rates of 25-38%   – SCOTTSDALE, Ariz., Nov. 18, 2016 (GLOBE NEWSWIRE) -- Cortice Biosciences announced today follow-up results from CB-017, a Phase 1/2 clinical trial evaluating TPI 287 plus bevacizumab (Avastin®) in patients with recurrent glioblastoma (GBM) who have not received prior bevacizumab.  These results will be presented this evening during a poster session at the 21st Annual Scientific Meeting of the Society of Neuro-Oncology. TPI 287 is a novel microtubule stabilizing agent that readily penetrates the blood-brain barrier.  Prior preclinical and clinical results support the potential of this agent for the treatment of aggressive brain cancers in patients with few therapeutic options. “Results from our TPI 287 development program continue to support meaningful drug activity in GBM,” said George Farmer, Ph.D., Chief Executive Officer of Cortice.  “Compared to overall survival rates observed in other multi-center clinical trials enrolling similar GBM populations, outcomes of CB-017 are very encouraging.  We look forward to continued development of TPI 287 for treatment of GBM and presenting final results from the Phase 1 portion of CB-017 at another medical meeting next year.” Twenty-four patients with recurrent GBM that had progressed beyond first line treatment and who had not received prior bevacizumab were enrolled in the dose-escalation portion of CB-017.  In addition to TPI 287 (140 to 220 mg/m2 administered every three weeks in seven dose cohorts), all patients received standard-of-care bevacizumab (10 mg/kg every two weeks).  Twenty and 23 patients were evaluable for overall response and overall survival, respectively. Key efficacy metrics are as follows: Safety data available from 22 patients enrolled in CB-017 supports the favorable tolerability profile of TPI 287.  With the exception of Grade 3 myelosuppression (3 patients), all adverse events regarded as possibly related to TPI 287 have been mild to moderate.  No dose limiting toxicities (DLTs) have been observed to date. Based on observations from CB-017 so far, an optimal dose of TPI 287 has been selected for the expansion stage of the trial.  Following guidance provided by FDA, results from this study will inform the design of a single Phase 3 registration trial for TPI 287 in GBM. “The improvement in median overall survival to 13.4 from 12.9 months appears to be driven by outcomes in patients treated at the higher doses of this study,” said Dr. Samuel Goldlust, Medical Director of the Brain and Spine Institute of the John Theurer Cancer Center in Hackensack, NJ and Principal Investigator of CB-017. “This positive survival trend and the excellent tolerability of TPI 287 observed in the study to date support continued investigation in recurrent glioblastoma, an indication in desperate need of new therapies.” TPI 287 is a novel taxoid which binds to and stabilizes the assembly of microtubules similarly to commonly used taxanes, including paclitaxel (Taxol® and Abraxane®) and docetaxel (Taxotere®).  In oncology treatment settings, microtubule stabilization by these agents leads to mitotic arrest and cancer cell death.  TPI 287 has advantages over these taxanes for the treatment of brain cancers due to its ability to penetrate the central nervous system, which is often shielded from systemic administration of other anti-cancer drugs. Microtubule stabilization by TPI 287 may also have potential for the treatment of neurologic disorders affected by tau protein pathology.  These include tauopathies such as Alzheimer’s disease and orphan diseases, such as progressive supranuclear palsy, corticobasal degeneration, and frontotemporal dementia. Glioblastoma (GBM) is the most aggressive and common form of brain cancer.  Five-year survival after diagnosis is about 5%.  The Central Brain Tumor Registry estimates that about 24,790 primary malignant brain tumors cases will be diagnosed in the US in 2016, 46% of which will be GBM.  Typical front-line treatments include stereotactic or whole brain radiotherapy plus temozolomide (Temodar®).  Patients with recurrent disease are candidates for treatment with Avastin®, the last drug approved by FDA for this disease. Cortice Biosciences, Inc. is a clinical-stage drug development company developing novel therapies for oncologic and neurologic disease indications with urgent unmet medical need.  More information can be found at www.corticebiosciences.com. This media release may contain forward-looking statements about Cortice Biosciences, which can be identified by the use of terminology such as "will," "would," "should," "expects," "anticipates," "intends," "plans," "believes," "may," "estimates," "predicts," "projects,” or similar expressions intended to identify such statements.  These statements reflect the current views of Cortice with respect to future events, are based on assumptions, and subject to risks and uncertainties.


NEW YORK, Dec. 8, 2016 /PRNewswire/ -- Dr. Andre Goy, Chairman of the John Theurer Cancer Center and board member of Cota, the leading data and technology platform for value-based precision medicine, presented "Impact of Charlson Comorbidity Index (CCI) and Refining the MIPI Index in...


SAN DIEGO, Dec. 3, 2016 /PRNewswire/ -- Dr. Andre Goy, Cota board member and President of the John Theurer Cancer Center, will present a new study utilizing real-world evidence to demonstrate the importance of comorbidities on outcomes of patients with mantle cell lymphoma at the 58th...

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