While BTI may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. Multiple patients have been treated in the safety and escalation portion of the trial, which will be followed by a two-stage efficacy portion of the clinical program. BXCL501 was well tolerated with no serious or severe adverse events across the entire dose range.Phase 3 Pivotal trials are anticipated to enroll approximately 600 to 700 patients (300-350 each in schizophrenia and bipolar disorder) and are designed to measure reduction in PEC at two hours as the primary endpoint, as used in clinical trials of other approved agents. Any such forward-looking statements represent management's estimates as of the date of this press release.
In this study, BXCL701 will be administered at a dose of 0.3 mg, twice daily for a total daily dose of 0.6mg (the previously defined maximum tolerated dose [MTD] of the drug), to all patients for a short period of 14 days. We believe it is highly differentiated from antipsychotics currently used as standard of care, which produce unwanted symptoms such as tremors, neutropenia and extra-pyramidal motor effects. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. "We believe BXCL701 may have the potential to extend treatment responses to KEYTRUDABXCL701 is an investigational orally administered innate immune activator designed to initiate inflammation in the tumor microenvironment. A data read out is expected in 2H 2019.A Clinical Trial Application (CTA) was accepted by the U.K.
BTI believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain.BTI may not realize its expectations, and its beliefs may not prove correct. The CCR2/CCR5 antagonist BMS-813160 is being trialed in combination with nivolumab or gem nab in metastatic pancreatic cancer patients NCT03184870]. December 11, 2019 7:00am The Phase 1 pharmacokinetic (bioavailability) and safety study of BXCL501 yielded positive top-line data in 28 healthy volunteers.The Phase 1b, randomized, double blind, placebo-controlled, multi-center, U.S. trial reported positive topline data in 90 schizophrenia patients. Forward-looking statements in this press release include, but are not limited to the timing and data from clinical development initiatives and trials for BXCL701 and the potential for BXCL701 to improve or extend treatment responses when combined with checkpoint inhibitors.
Approved and experimental immunotherapies often struggle to address cancers that appear "cold" or uninflamed. It is designed the potential to generate a calming effect without producing excessive sedation. BTI's two most advanced clinical development programs are BXCL501, a sublingual thin film formulation designed for acute treatment of agitation resulting from neurological and psychiatric disorders, and BXCL701, an immuno-oncology agent designed for the treatment of prostate cancer and for treatment of pancreatic cancer.
When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. Lead-in Stage - in which the safety and tolerability of the combination of BXCL701 administered once daily (QD) on Days 1 to 14 of a 21-day cycle plus PEMBRO 200 mg administered intravenously (IV) on Day 1 of every 21 days will be assessed and confirmed in patients with metastatic castration-resistant prostate cancer (mCRPC). Managing patient agitation in neuropsychiatric and neurodegenerative disorders represents a significant challenge for physicians and caregivers, and we believe BXCL501 has the potential to address these challenges while providing an efficient treatment regimen for patients.The Phase 1b trial of intravenously dosed dexmedetomidine in schizophrenia patients demonstrated safety and established an optimal dose range for BXCL501.
Results from secondary analyses showed statistically significant calming as measured by the ACES (Agitation-Calmness Evaluation Scale) at two hours compared to placebo following a single dose of 80 mcg (p=0.0156), 120 mcg (P=0.0005) and 180 mcg (P<0.0001). A selective adrenergic agent with a sublingual route of administration, BXCL501 is designed to be easy to administer and has shown a rapid onset of action in clinical studies. These forward-looking statements should not be relied upon as representing BTI's views as of any date subsequent to the date of this press release.Thank you for subscribing! For more information, please visit This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. BTI’s two most advanced clinical development programs are BXCL501, an investigational, sublingual thin film formulation for the acute treatment of agitation resulting from neuropsychiatric disorders, and BXCL701, an investigational orally administered systemic innate immunity activator for the treatment of a rare form of prostate cancer and for treatment of pancreatic cancer in combination with other immuno-oncology agents.BXCL501 is our most advanced neuroscience clinical program, being developed initially for the treatment of acute agitation in patients with schizophrenia and bipolar disorders.
Development plans for the acute treatment of agitation with BXCL501 in hyperactive delirium and opioid withdrawal are underway.BTI is currently enrolling patients in the U.S. in a clinical trial evaluating the double combination of BXCL701 and Keytruda® for treatment emergent Neuroendocrine Prostate Cancer (tNEPC).