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Cortice Announces Enrollment of a Phase 1 Trial Evaluating TPI 287 Plus Radiotherapy for Treatment of Lung and Breast Cancer Metastases to the Brain

NEW YORK, Jan. 7, 2015 (GLOBE NEWSWIRE) -- Cortice Biosciences announced today that enrollment has begun in a Phase 1 clinical trial designed to determine safety and efficacy of TPI 287 in combination with standard-of-care fractionated stereotactic radiotherapy (FSRT) for the treatment of patients with advanced lung and breast cancers that have spread to the brain. TPI 287 is a novel microtubule stabilizing agent similar to the commonly used taxanes, paclitaxel (Taxol® and Abraxane®) and docetaxel (Taxotere®), but with the unique properties of being able to evade common drug resistance mechanisms and readily penetrate the blood-brain barrier.

Conducted by investigators at Moffitt Cancer Center in Tampa, FL, this trial is designed to determine the maximum tolerated and recommended Phase 2 dose of three weekly infusions of TPI 287 administered concurrently with FSRT for treatment of tumors metastatic to the brain. Taxanes have long been known to sensitize tumors to the killing effects of radiation therapy, and are often prescribed in combination for treatment of cancers originating at primary sites outside of the brain. Given the brain penetrable properties of TPI 287 and encouraging activity in a mouse model of brain metastases formation (Fitzgerald et al., Mol. Can. Ther. (2012)), this trial will test whether TPI 287 can safely do the same when combined with FSRT for treatment of tumors that spread to the brain while improving local control and decreasing distant brain failure.

"The unique properties of TPI 287 make this drug an ideal candidate to evaluate in combination with FSRT for the treatment of brain metastases," said Dr. Solmaz Sahebjam of Moffitt Cancer Center and Principal Investigator of this trial. "Radiotherapy is currently the only approved therapeutic option for treatment of tumors that spread to the brain and which cannot be surgically removed. Despite conferring relatively high response rates, radiation treatment alone remains inadequate, leaving room for much improvement. I am excited to be part of this exploratory study in efforts to bring a new treatment modality to cancer patients."

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 Metastases to the Brain

According to the National Cancer Institute, brain metastases occur in 20-40% of all cancer patients, totaling 98,000-170,000 new cases each year in the United States. Most commonly, brain metastases originate from lung cancers (50%), breast cancers (15-20%), and melanoma (10%). Fractionated stereotactic radiotherapy (FSRT) or whole brain radiotherapy (WBRT) remains the standard of care for treatment of patients with or without surgery, with response rates ranging from 60-80% seen with the former. Nevertheless, practically all tumors recur and mortality rates due to brain metastases are extremely high.

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.corticebiosciences.com.

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

Source: Cortice Biosciences