NEW YORK, Jan. 9, 2014 (GLOBE NEWSWIRE) -- Cortice Biosciences, Inc. 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) who have not received prior anti-angiogenic treatment for their disease (clinicaltrials.gov ID: NCT01933815). 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 circumvent common drug resistance mechanisms and cross the blood-brain barrier.
Prior experience with TPI 287 administered to recurrent GBM patients has shown 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 of recurrent GBM.
"Glioblastoma is an aggressive brain tumor with few effective treatments," said Dr. Samuel Goldlust, Medical Director of the Neuro-Oncology Division at the John Theurer Cancer Center in Hackensack, NJ. "Avastin provides meaningful benefit in our patients with recurrent disease, but has significant limitations. Based upon the susceptibility of glioblastoma cells to taxanes and the ability of TPI 287 to readily cross the blood-brain barrier, the potential of combining this drug with Avastin looks very promising."
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, as prescribed in the Avastin package insert. All patients will have been diagnosed with progressive GBM after having received standard-of-care first-line therapy with radiation plus temozolomide (Temodar®). Once the MTD for TPI 287 is established, it is anticipated that patients enrolled in the expansion stage of the trial will be randomized to receive Avastin either alone or in combination with TPI 287. Key endpoints of the trial include progression-free survival, overall response rate, overall survival, and safety. Objective response and disease progression will be assessed per RANO criteria.
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.
About Glioblastoma
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.