Navigation Links
Ambit Biosciences Initiates Two Phase I Clinical Trials
Date:12/20/2010

SAN DIEGO, Dec. 20, 2010 /PRNewswire/ -- Ambit Biosciences (Ambit), today announced that it has initiated separate Phase I trials for two products AC430, a selective Janus Kinase 2 (JAK2) inhibitor, and AC480, a pan-HER inhibitor.

The Phase I trial for AC430 is a two part, placebo-controlled, single ascending, and multiple ascending dose trial in healthy volunteers.  AC430 will be administered orally once-daily and doses escalated until a maximum tolerated or maximum feasible dose is established.  In addition to evaluating the safety, tolerability, and pharmacokinetics of AC430, the study will also assess cytokine signal transduction.  

The Phase I trial for AC480 is a multi-center, dose escalation study with AC480 administered by intravenous infusion on days one and two of a 21 day cycle, either alone or in combination with docetaxel.  The trial will assess safety, pharmacokinetics and anti-tumor activity of AC480 in patients with advanced solid tumors.

"The initiations of these studies are important milestones," said Alan Lewis, President and CEO Ambit Biosciences. "AC430 has demonstrated convincing efficacy in pre-clinical models of autoimmune and inflammatory diseases, and AC480 IV was developed to assess whether pulsatile doses of a pan-HER inhibitor administered in combination with a taxane such as docetaxal would produce synergistic anti-tumor activity."

About AC430AC430 was specifically developed to be a best-in-class JAK2 inhibitor.  In preclinical studies, AC430 has exhibited potency against JAK2 in cell-based models that is at least equivalent, and in most cases superior to, competing JAK2 inhibitors, and also has excellent oral pharmacokinetic properties.  In preclinical oncology and autoimmune models, AC430 is well tolerated and has significant efficacy at oral doses as low as 10 mg/kg/day.  JAK2 has been implicated as a target for therapy in both oncology and autoimmune disease.

About AC480AC480 is a small molecule kinase inhibitor that selectively inhibits the HER family of receptors, HER1, HER2, HER3 and HER4.  Excessive HER signaling has been associated with the development of a wide variety of types of solid tumors, including those found in lung, breast, head and neck and brain cancers.  Currently marketed HER inhibitors inhibit only one or two of the HER family members and a pan-HER inhibitor that inhibits all of the HER receptors may be effective in more cancer types.  Published data with oral HER inhibitors administered in combination with taxanes, such as docetaxel, demonstrate activity in clinical studies and these clinical data are supported by preclinical data demonstrating that combining HER inhibitors with taxanes produces synergistic anti-tumor activity.  An intravenous formulation of a pan-HER inhibitor such AC480 enables high pulsatile doses to be administered in combination with taxanes.

About Ambit BiosciencesAmbit Biosciences Corporation is a biotechnology company engaged in discovering, developing and commercializing targeted small molecule therapeutics for the treatment of cancer.

Ambit contacts:Alan Fuhrman, Chief Financial Officer, Ambit Biosciences (858) 334-2133, afuhrman@ambitbio.com

Christopher Morl, Chief Operating Officer, Ambit Biosciences (858) 334-2134, cmorl@ambitbio.comContact:Carol RuthThe Ruth Group(646) 536-7004cruth@theruthgroup.com
'/>"/>

SOURCE Ambit Biosciences Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Ambit Biosciences Strengthens Board of Directors and Executive Team
2. Ambit Biosciences Files Registration Statement for Proposed Initial Public Offering
3. Ambit Biosciences and Astellas Enter Strategic Partnership to Research, Develop and Commercialize FLT3 Kinase Inhibitors in Multiple Indications
4. Ambit Biosciences Corporation Presents Phase I Clinical Results of AC220 in Patients With Acute Myeloid Leukemia at ASH Conference
5. Ambit Biosciences Corporation Announces Presentations Profiling AC220 Clinical and Non-Clinical Data at 51st American Society of Hematology Annual Meeting
6. Catalyst Biosciences Receives Milestone Payment from Pfizer for Progress in Lead Hemostasis Program
7. Cell Biosciences Announces US Patent Issuance
8. Sofie Biosciences Raises $2M to Support Development of Diagnostic Imaging Agents and Devices
9. Sangamo BioSciences Announces Presentation of Phase 2 Data in Amyotrophic Lateral Sclerosis (ALS) at Society for Neuroscience Meeting
10. Regado Biosciences, Inc. Introduces REG3, a Novel Aptamer-Based Inhibitor of Glycoprotein VI and its Matched Active Control Agent, at the American Heart Association (AHA) Scientific Sessions 2010 Meeting
11. Cardio3 BioSciences Announces Positive Outcome of the C-Cure(R) Phase II Clinical Trial in Heart Failure Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... Aptuit, LLC, hat heute den ... Massachusetts General Hospital (MGH) unter Leitung von Dr. ... Identifizierung und Validierung neuartiger Targets in gramnegativen Bakterien.  Aptuit ... von Antibiotika bei der Behandlung schwerer Infektionen entgegenwirken können. ... ...
(Date:1/24/2017)... -- Laboratory Markets Limited has completed a comprehensive market ... both clinical and research laboratory settings. This study, which ... $6.8 billion and growing to $9.2 billion (CAGR of ... of mass spectrometry across more than 5,200 clinical and ... in the use of mass spectrometry in terms of ...
(Date:1/24/2017)... 2017 Global Market for Pharmaceutical ... A majority of medicines & drugs produced in ... (API), and such processes require alcoholic solvents such as ... of pharmaceutical solvents continues to be concentrated in the ... (APEJ) region as leading API suppliers and ...
Breaking Medicine Technology:
(Date:1/24/2017)... ... January 24, 2017 , ... ... semi-final round of the 2017 Cupid's Cup Entrepreneurship Competition. Chaired by Under Armour ... in 2017. The entrepreneurs will showcase their businesses on February 6, 2017, at ...
(Date:1/24/2017)... ... January 24, 2017 , ... ... today that its annual Solutions Series of webinars will start January 31 with ... discussing a number of current health and benefits topics, including employee engagement, pricing ...
(Date:1/24/2017)... ... January 24, 2017 , ... His message has been heard by more than ... End Distracted Driving , Joel Feldman, has reached his biggest national audience yet: the ... of the top newspapers in circulation in the country, and he hopes it will ...
(Date:1/24/2017)... (PRWEB) , ... January 24, 2017 , ... Center ... 21st century leadership, has named Hector M. Chavez, Manager, Employee & Labor Relations at ... center - as its Hispanic Leader of the Month. City of Hope is committed ...
(Date:1/24/2017)... (PRWEB) , ... January 24, 2017 , ... ... is the focus of a new report from the Frank Hawkins Kenan ... School. , Influential business leaders, academics and policy makers identified concrete solutions at ...
Breaking Medicine News(10 mins):