Navigation Links
Intra-Cellular Therapies Announces Completion of Phase I Single Rising Dose Trial of First-in-Class Selective Phosphodiesterase 1 (PDE1) Inhibitor and Reports Top-line Safety and Pharmacokinetic Findings

NEW YORK, Feb. 19, 2013 /PRNewswire/ -- Intra-Cellular Therapies, Inc. ("ITI") today announced the completion of a Phase I single rising dose study of its phosphodiesterase 1 (PDE1) inhibitor, ITI-214.  ITI-214, a novel, first-in-class selective PDE1 inhibitor, was discovered by ITI and is in development under an exclusive collaboration with Takeda Pharmaceutical Company Limited for the treatment of Cognitive Impairment Associated with Schizophrenia (CIAS). 

The primary objectives of the Phase I study were to determine the safety, tolerability and pharmacokinetic profile of single oral doses of ITI-214 in healthy volunteers.  The study was conducted as a randomized, double-blind, placebo-controlled study in 70 subjects.  The results indicated that ITI-214 was safe and well-tolerated across a broad range of single oral doses.  Moreover, ITI-214 demonstrates a favorable pharmacokinetic profile consistent with once-a-day dosing. The study represents a significant milestone as it is the first demonstration of the safety of a PDE1 inhibitor in a Phase 1 clinical trial.

"We are pleased with the advancement of ITI-214 in clinical development," stated Sharon Mates , Ph.D., Chairman and Chief Executive Officer of Intra-Cellular Therapies.  "The data obtained for ITI-214 support its continued development for the treatment of Cognitive Impairment Associated with Schizophrenia and other neuropsychiatric and neurological disorders."

About Schizophrenia

Schizophrenia is a major neuropsychiatric disorder that affects over one percent of the world population with an illness that begins in late adolescence and lasts a lifetime. Its best known symptoms are "positive symptoms", which include hallucinations and delusions; but other mental functions are also affected, including social and motivational skills ("negative symptoms") and cognitive behaviors, like inattention and poor memory. Current antipsychotics are effective primarily on reducing positive symptoms but are largely ineffective at reducing negative and cognitive symptoms. The medical need in this disease area is enormous.

About PDE1 Inhibitors

These compounds are unique, orally available, investigational drugs being developed for the treatment of cognitive impairments accompanying schizophrenia and other neurological and neuropsychiatric disorders, including Alzheimer's disease, Attention Deficit Hyperactivity Disorder and Parkinson's disease. These compounds may also have the potential to improve motor dysfunction associated with these disorders. These compounds are very selective for the PDE1 subfamily relative to other PDE subfamilies. They have no known significant off target activities at other enzymes, receptors or ion channels.

About Intra-Cellular Therapies, Inc.

Intra-Cellular Therapies, Inc. (ITI) is a biopharmaceutical company that is developing novel drugs for the treatment of diseases and disorders of the Central Nervous System (CNS). The Company was formed in 2002 to exploit intracellular signaling pathways of the brain in its efforts to develop novel CNS therapeutics. The Company's initial efforts were built on the insights generated from the Nobel Prize winning science of Dr. Paul Greengard at The Rockefeller University, the scientific founder of ITI. Using novel technologies developed at ITI, the Company has developed a pipeline of drugs that have the potential to treat a wide range of diseases associated with the CNS. Additional information about ITI is available through its corporate website,  

Allen A. Fienberg , Ph.D., Vice President, Business Development, Intra-Cellular Therapies, Inc., +1-212-923-3344; or Lisa Burns (Investors), or Justin Jackson (Media), both of Burns McClellan, Inc., +1-212-213-0006,


SOURCE Intra-Cellular Therapies, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Grant Awarded to Study Novel Therapies for Muco-Obstructive Diseases Includes Studies on Cempras Solithromycin (CEM-101) in a Cystic Fibrosis Anti-inflammatory Model
2. Launch Of Premium-priced, Novel Targeted Therapies Will Drive Growth In The Acute Leukemia Markets Beginning In 2015
3. Generex Provides an Overview of its Cancer Immunotherapy Product, AE37, and Potential in Early Breast Cancer Given Current and Potential Future Therapies
4. The Treatment Landscape for Hepatocellular Carcinoma Will Change Dramatically Over the Next Ten Years Due to the Launch of New Therapies in the United States and EU5
5. Oncologists in the United States and Europe Indicate that Novel Chemotherapies Hold the Most Near-Term Promise for Improving Outcomes in Soft Tissue Sarcoma
6. Takeda Receives FDA Approval for Three New Type 2 Diabetes Therapies, NESINA (alogliptin) and Fixed-Dose Combinations OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl)
7. Oncobiologics and Boston Oncology Team Up to Deliver Biosimilar Therapies for Cancer and Immune Disease to Middle East and North African Markets
8. Chimerix Presents Data Highlighting Burden Of Care Associated With Current Antiviral Therapies In Stem Cell Transplantation
9. Growing Prevalence of Asthma is Fueling Vigorous Industry Competition for Effective, Affordable Therapies
10. Neurostimulation Devices Market to 2018 - Technological Advances and Robust Pipeline with Multi-Indication Potential and Non-Invasive Therapies to Drive Growth
11. Multi-Targeted Therapies - New Wave of Combination Therapies in Late Stage Development for Lung Cancer Offer Promise
Post Your Comments:
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... announced the addition of the  "2016 ... the Global Cell Surface Testing Market: ... report to their offering.  --> ... addition of the  "2016 Future Horizons ...
(Date:11/26/2015)... , Nov. 26, 2015 Research and ... the "Advanced Wound Care Market by Type (Dressings, ... End User (In-Patient Facility, Out-Patient Facility), and Geography - ... --> --> ... description, definition and forecast of the global advanced wound ...
(Date:11/26/2015)... , November 26, 2015 ... the "Self Administration of High Viscosity Drugs" ... ) has announced the addition of the ... report to their offering. --> Research ... addition of the "Self Administration of High ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... , ... MPWH, the No.1 Herpes-only dating community in the world, revealed that over 50% of ... than 3.7 billion people under the age of 50 – or 67% of the population ... global estimates of HSV-1 infection . , "The data shocks us highly!" said Michelle ...
(Date:11/27/2015)... DE (PRWEB) , ... November 27, 2015 , ... ... member of the well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s ... an independent group of Microsoft Dynamics SL software users, partners, industry experts and ...
(Date:11/27/2015)... MINNEAPOLIS, Minn. (PRWEB) , ... November 27, 2015 ... ... you start failing. Secura Consultants has prided itself for not only fulfilling the ... best income protection solutions at an affordable price and providing top-tier customer service. ...
(Date:11/27/2015)... ... ... CBD College is proud to announce that on November 20th, ... its Diagnostic Medical Sonography program. CBD College is honored to join this very short ... universities in the state of California make the cut. CBD College is officially the ...
(Date:11/27/2015)... ... November 27, 2015 , ... Dr. Thomas Dunlap ... and Dr. Tucker Bierbaum with Emergency Medicine at St., Joseph Health System’s ... STEMI and Sepsis conditions present in similar ways and require time-critical intervention to avoid ...
Breaking Medicine News(10 mins):