Cortice Announces Enrollment of a Clinical Trial Targeting Tau Dysfunction in Mild-to-Moderate Alzheimer's Disease

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| Source: Cortice Biosciences

NEW YORK, Jan. 21, 2014 (GLOBE NEWSWIRE) -- Cortice Biosciences announced today that enrollment has begun in a Phase 1 open-label dose-escalation trial designed to evaluate safety, tolerability and preliminary efficacy of the company's lead drug candidate, TPI 287, for treatment of patients with mild-to-moderate Alzheimer's disease (www.clinicaltrials.gov ID NCT01966666). TPI 287 is an abeotaxane, a taxoid that binds to and stabilizes microtubules (MTs) similarly to the taxanes, paclitaxel and docetaxel. A distinct advantage of TPI 287 over the taxanes is an ability to readily cross the blood-brain barrier.

A hallmark of Alzheimer's disease (AD) and related "tauopathies" is the presence of neurofibrillary tangles composed of dysfunctional tau protein in the brain. The normal role of tau is to help stabilize and ensure the proper integrity and function of neuronal MTs in the central nervous system. Tau dysfunction has been correlated with MT destabilization and impaired cognition, which can be ameliorated by MT stabilizing agents in tauopathy animal models. The MT stabilizing properties of TPI 287, combined with its ability to penetrate into the brain, support the rationale for evaluating TPI 287 as treatment of tauopathies, including AD.

"The compelling body of preclinical work demonstrating the efficacy of MT stabilizing agents in tauopathy models supports the rationale for evaluating TPI 287 as treatment of AD and related neurodegenerative disorders," said George Farmer, Ph.D., Chief Executive Officer of Cortice. "From this study, we hope to learn more about the potential that TPI 287 may have in treating afflicted patients who are in dire need of effective treatments."

About TPI 287

TPI 287 is a taxoid derivative, known as an abeotaxane, which binds to and stabilizes the assembly of microtubules similarly to the taxanes, paclitaxel and docetaxel. TPI 287 has advantages over the taxanes due to its propensity to penetrate the central nervous system. Microtubule stabilization by TPI 287 in the brain may have potential for the treatment of neurologic diseases associated with dysfunctional tau protein and defective microtubule architecture. As an anti-cancer agent designed to inhibit cellular division and growth, TPI 287 is also being evaluated for the treatment of glioblastoma, secondary brain metastases, and pediatric neuroblastoma.

About tauopathies

Tauopathies are a collection of over twenty different neurodegenerative diseases characterized by the presence of neurofibrillary tangles (NFTs) in the brain. NFTs are composed of dysfunctional tau protein whose presence has been directly correlated with disease severity and progression. Tau dysfunction has been associated with defective microtubule architecture in the axons of affected neurons, which is a major cause of impaired neuronal function. Tauopathy examples include orphan indications such as progressive supranuclear palsy (about 25,000 patients diagnosed in the U.S.), corticobasal degeneration (about 600 patients), frontotemporal dementia (about 55,000 patients) and much larger indications such as Alzheimer's disease (about 5 million patients). More information can be found at www.psp.org, www.theaftd.org, and www.alzfdn.org.

About Cortice Biosciences

Cortice Biosciences 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.
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