×

Cortice Biosciences Announces Updated Results From a Phase 1/2 Clinical Trial Evaluating TPI 287 for Treatment of Recurrent Glioblastoma

– 56% objective response rate in 16 evaluable patients treated with TPI 287 plus Avastin®

– Overall survival results maturing: median 12.6 months; 73% alive at 9 months, 67% alive at 12 months –

– Safety profile remains favorable; no dose-limiting toxicities to date –

PHILADELPHIA, April 21, 2015 (GLOBE NEWSWIRE) -- Cortice Biosciences announced today interim results from CB-017, a Phase 1/2 clinical trial evaluating TPI 287 plus bevacizumab (Avastin®) for the treatment of patients with glioblastoma multiforme (GBM) that has recurred following first-line treatment for their disease. These results demonstrate a high response rate with the combination, survival outcomes which compare favorably to outcomes seen in other studies with standard-of-care bevacizumab alone, and a favorable safety profile with no dose limiting toxicities observed to date. The results were presented this morning in a poster session at the 2015 Annual Meeting of the American Association for Cancer Research in Philadelphia, PA.

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 brain cancers, including GBM, a highly aggressive malignancy with few therapeutic options.

“The updated results of CB-017 continue to support the safety and potential efficacy of TPI 287 in glioblastoma,” said Samuel Goldlust, M.D., Medical Director of the Brain and Spine Institute of the John Theurer Cancer Center in Hackensack, NJ and Principal Investigator of the study. “Even at doses below the maximum tolerated dose, the frequency of durable responders and overall survival exceed historical controls. This is particularly encouraging in a disease with so few effective therapeutic options at recurrence.”

“Read-outs from this on-going study remain consistently positive and impressive, especially when compared to results from landmark studies evaluating Avastin alone in GBM,” said George Farmer, Ph.D., Chief Executive Officer of Cortice. “Moreover, the evolving overall survival signal appears to correlate with overall response, which is consistent with what has also been seen in these other GBM studies. We look forward to presenting further updates from our GBM studies later this year.”

Results in detail

Cortice is running two multi-center clinical trials with TPI 287 in combination with bevacizumab for the treatment of patients with recurrent GBM who have either not received prior bevacizumab (CB-017) or who have progressed through a bevacizumab-containing regimen (CB-018). The goal of both trials is to determine the maximum tolerated dose (MTD) of TPI 287 in combination with bevacizumab as well as objective response, progression free survival, and overall survival.

In CB-017, 18 recurrent GBM patients have been enrolled to date. In addition to TPI 287 (140 to 180 mg/m2 administered every three weeks), all patients also received bevacizumab (10 mg/kg every two weeks). Sixteen patients were evaluable for response as per RANO criteria by the site investigators, and 17 patients were evaluable for overall survival.

Key efficacy results are as follows:

  • Overall response and progression free survival
    • 9 patients achieved an objective response (2 complete; 7 partial), corresponding to a 56% overall response rate
    • 6 patients achieved stable disease and 1 patient had progressive disease at first assessment for response, corresponding to a 94% disease control rate
    • Median progression free survival is 4.5 months (95% C.I. 4.1-10.7)
  • Overall survival
    • Median overall survival is 12.6 months (95% C.I. 7.6-NR) after occurrence of 40% of possible events
    • Of 11 eligible patients for analysis, 8 (73%) were alive for at least 9 months
    • Of 9 eligible patients for analysis, 6 (67%) were alive for at least 12 months

Safety data available from 16 patients treated at doses up to 180 mg/m2 of TPI 287 continues to support the favorable tolerability profile of this agent. With the exception of Grade 3 myelosuppression (2 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. The CB-017 protocol indicates that if no DLT arises in the TPI 287 180 mg/m2 dose cohort, continued dose escalation should continue in order to determine the MTD in this treatment setting.

About TPI 287

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 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 23,180 primary malignant brain tumors cases will be diagnosed in the US in 2015, 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 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 medical need. More information can be found at www.corticebiosciences.com.

Safe Harbor Statement

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.

Contact: Cortice Biosciences, Inc. 646-747-9090 info@corticebio.com

Source: Cortice Biosciences