NEW YORK, March 20, 2014 (GLOBE NEWSWIRE) -- Cortice Biosciences announced today that enrollment has begun in the first stage of a Phase 2 open-label trial designed to evaluate the safety and efficacy of the Company's lead drug candidate, TPI 287, in combination with standard-of-care Avastin® (bevacizumab) for treatment of patients with recurrent glioblastoma (GBM) that has progressed following Avastin treatment alone (clinicaltrials.gov/NCT02047214). TPI 287 is an abeotaxane, a novel taxoid derivative that works similarly to taxane chemotherapeutics, such as Taxol®, Abraxane®, and Taxotere®, but with the distinct advantages of being able to readily cross the blood-brain barrier and evade common drug resistance mechanisms.
The first stage of this trial is designed to determine the maximum tolerated dose (MTD) of TPI 287 administered every three weeks when used in combination with Avastin administered at 10 mg/m2 every two weeks. All patients will have GBM that that has progressed while on or following treatment with Avastin. Once the MTD for TPI 287 is established in this setting, Cortice plans to expand to the second stage of the trial to evaluate additional patients with TPI 287 plus Avastin. Safety is the primary endpoint of the study. Key secondary endpoints, including overall response rate and progression-free survival, will be assessed per RANO criteria.
Prior experience with TPI 287 in recurrent GBM patients indicates that the drug may have meaningful impact on treating infiltrative disease, which often evades Avastin therapy. This suggests that TPI 287 and Avastin may be synergistic as treatment for recurrent GBM. Also designed to investigate this potential synergy, Cortice is conducting a separate clinical trial to evaluate TPI 287 in combination with Avastin for treatment of recurrent GBM naïve to prior Avastin treatment (clinicaltrials.gov/NCT01933815).
"We are pleased to be part of this important clinical study evaluating TPI 287 in recurrent GBM, a disease with very few effective treatment options," said Dr. Burt Nabors, Director of the Division of Neuro-Oncology at the University of Alabama at Birmingham. "Results from this trial, as well as Cortice's other Phase 2 trial evaluating TPI 287 in patients naïve to bevacizumab, could be informative and instrumental in bringing a new therapy to our patients."
About TPI 287
TPI 287 is a novel taxoid derivative, known as an abeotaxane, 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 the taxanes due to its ability to circumvent common drug resistance mechanisms and its propensity to penetrate the central nervous system. Accordingly, TPI 287 has the potential to treat primary brain tumors and secondary brain metastases that are often shielded from systemic administration of taxanes. 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 22,800 primary malignant brain tumors cases will be diagnosed in the US in 2014, 16% 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 FDA approved agent for this disease.
About Cortice Biosciences
Cortice Biosciences, Inc. is a clinical-stage drug development company pioneering novel therapies for the treatment of oncologic and neurologic disease indications with urgent unmet medical need. More information can be found at www.corticebio.com.
Cortice Biosciences, Inc. 646-747-9090
New York, New York, UNITED STATES
Cortice Biosciences, Inc. 646-747-9090
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