Navigation Links
Ambit Biosciences Initiates Two Phase I Clinical Trials

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,

Christopher Morl, Chief Operating Officer, Ambit Biosciences (858) 334-2134, cmorl@ambitbio.comContact:Carol RuthThe Ruth Group(646)

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:
(Date:11/26/2015)... 26, 2015 ... of the  "2016 Future Horizons and ... Surface Marker Testing Market: Supplier Shares, ... their offering.  --> ... the  "2016 Future Horizons and Growth ...
(Date:11/25/2015)... WASHINGTON , Nov. 25, 2015  The ... Obstetricians and Gynecologists (ACOG), and the March of ... bipartisan Protecting Our Infants Act of 2015 ... the number of newborns born exposed to drugs, ... Since the bill,s introduction, all three organizations have ...
(Date:11/25/2015)... 25, 2015  ARKRAY USA , ... provide evidence demonstrating the accuracy of its blood glucose ... Insulin Resistance, Diabetes and Cardiovascular Disease in ... Company,s GLUCOCARD ® 01 meter and the Assure ... The ability to accurately measure glucose levels in blood ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... CBD College is proud ... Education Programs (CAAHEP) awarded accreditation to its Diagnostic Medical Sonography program. CBD College is ... only one of twelve colleges and universities in the state of California make the ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... Dr. ... Medical Associates, Inc. and Dr. Tucker Bierbaum with Emergency Medicine at St., ... observed that both STEMI and Sepsis conditions present in similar ways and require time-critical ...
(Date:11/27/2015)... ... November 27, 2015 , ... Indosoft Inc., ... the incorporation of Asterisk 11 LTS (Long Term Support) into its Q-Suite 5.10 ... brings Q-Suite 5.10 up-to-date with a version of Asterisk that will receive not ...
(Date:11/26/2015)... ... 2015 , ... Inevitably when people think Thanksgiving, they also think Holiday sales ... Black Friday and Cyber Monday massage chair sales to receive the best ... low to find the best massage chair deals, they can see all of the ...
(Date:11/26/2015)... ... November 26, 2015 , ... Somu Sivaramakrishnan announced today that ... Somu now offers travelers, value and care based Travel Services, including exclusive pricing ... well as, cabin upgrades and special amenities such as, shore excursions, discounted fares, ...
Breaking Medicine News(10 mins):