Navigation Links
Semafore's SF1126, a Vascular Targeted Pan-PI3K/mTOR Inhibitor, Is Well Tolerated and Demonstrates Activity in Phase I Solid Tumor Patients
Date:5/30/2009

Clinical Data Presented at the 2009 ASCO Meeting

INDIANAPOLIS, May 30 /PRNewswire/ -- Semafore Pharmaceuticals, Inc., a privately held cancer drug discovery and development company, today presented data from a Phase I clinical trial of its vascular targeted pan-PI3K/mTORC1/2 inhibitor, SF1126, at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Orlando, Florida.

Dr. E. Gabriela Chiorean, from the Indiana University Simon Cancer Center in Indianapolis, IN presented the interim Phase I data on SF1126 in 36 advanced solid tumor patients. The majority of patients were heavily pretreated with a median of four prior chemotherapy regimens. Sixteen of 36 (44%) patients achieved disease stabilization with a median duration of 12 weeks. Of note, a GIST, endometrial, and prostate cancer patient each achieved durable stable disease for 20 weeks (5 mos.). These specific tumor types are associated with aberrations of the PI3K pathway that commonly lead to resistance and poor prognostic outcomes.

Pharmacodynamic analysis of tumor tissue confirmed inhibition of the PI3K pathway by complete absence of a downstream target (pS6). In contrast, a normal tissue (skin) demonstrated no inhibition providing evidence of tumor selectivity of SF1126. Pharmacokinetics displayed dose proportionality and no accumulation between cycles.

SF1126 was well tolerated. The most common side effects were grade 1 or 2 vomiting (42%), nausea (39%), diarrhea (33%), fever (22%), fatigue (19%), chills (14%), and puritis (11%). There were two patients with grade 3 toxicity, one with diarrhea, the other with urticaria and pruritis. Notably, there were no clinically significant changes in glucose or insulin levels reported.

"Based on these Phase I results we are encouraged that SF1126 is well tolerated and may hold promise for the treatment of solid tumor malignancies," said Dr. Chiorean.

This multi-center Phase I study was conducted at: Indiana University Simon Cancer Center, Indianapolis, IN; Arizona Cancer Center, Tucson, AZ; Winship Cancer Institute, Emory University, Atlanta, GA; Scottsdale Clinical Research Institute, Scottsdale, AZ.

About SF1126

SF1126 is the only clinical stage vascular targeted pan-PI3K inhibitor that selectively inhibits all PI3K class I isoforms and other key members of the PI3K superfamily, including mTORC1/2, DNA-PK, PLK-1, CK2, ATM and PIM-1. SF1126 is designed to inhibit both angiogenesis and cell proliferation by targeting and binding to integrins that are expressed on the surface of new tumor vasculature and within the tumor compartment.

In preclinical xenograft models SF1126 has demonstrated broad activity as a single agent; synergy with commonly used chemotherapy agents, targeted agents, and radiation; and has been shown to reverse resistance mediated through the PI3K/PTEN pathway.

About PI3 Kinase

Phosphatidylinositol 3 kinases (PI3K) are involved in one of the major pathways of intracellular signal transduction and are important in controlling cell growth/angiogenesis, differentiation, proliferation and survival/apoptosis. Dysregulation of the PI3 kinase signaling cascades can lead to cancer and aberrant PI3K pathway activity is observed with high frequency in a variety of tumor types. PI3K signaling through its downstream effectors AKT and mTOR is also known to promote tumor cell survival, proliferation, and growth. Dysregulation of PI3K signaling is also thought to contribute resistance to a variety of anticancer therapies. Thus, PI3K is considered a high value target in treating cancer.

About Semafore Pharmaceuticals, Inc.

Semafore is a clinical stage drug discovery and development company focused on small molecule modulators of the PI3 kinase and PTEN cell signaling pathway, a promising target pathway for multiple disorders, including the company's focus - cancer. Semafore is a leader in the development of PI3K inhibitors and one of the first biopharmaceutical companies to focus on both PI3K and PTEN inhibitors. The Company has successfully discovered and is developing a portfolio of drug candidates addressing these targets. Semafore is also leveraging its experience in the PI3K arena to identify and design inhibitors that block multiple pathways. For more information visit the Company's web site at www.SemaforePharma.com.


'/>"/>
SOURCE Semafore Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Semafore Pharmaceuticals Reports Positive Interim Results from a Phase I Study of SF1126, a Targeted Pan-PI3K Inhibitor, in Patients with Advanced Solid Tumors
2. SF1126, Semafores PI3 Kinase Inhibitor, Found to Block Angiogenic Signaling From Both VEGF and Bv8 in Multiple Cell Lines
3. Clinical Data on Semafores SF1126, a Vascular Targeted Pan-PI3K/mTOR Inhibitor, to be Presented at the 2009 ASCO Meeting
4. ACTOS(R) (pioglitazone HCl) Demonstrates Reduced Risk of Ischemic Cardiovascular Disease in Patients with Type 2 Diabetes
5. Cleveland Clinic Summits to Focus on Cardiovascular Medical Innovation
6. Anthera Announces Completion of Enrollment and Dosing in Phase II Trial of A-002 for the Treatment of Cardiovascular Disease
7. Anthera Announces Positive Phase II Clinical Results From A-002 Cardiovascular Disease Trial
8. Cardiologists Tackle Next Frontier in Cardiovascular Disease
9. Enrollment of Women in Cardiovascular Trials Fails to Meet Current Federal Mandates
10. Synvista Announces New Data Showing Haptoglobin Type Predicts Effectiveness of Tight Glycemic Control on Cardiovascular Outcomes in Patients with Diabetes
11. New Analysis of METEOR Study Demonstrate Effects of AstraZenecas CRESTOR(R) (Rosuvastatin Calcium) on Atherosclerosis in Patients With Two or More Risk Factors for Cardiovascular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/27/2017)...  Commended for their devotion to personalized service, SMP Pharmacy ... one in the South Florida Business Journal,s 50 Fastest-Growing Companies, ... list, the national specialty pharmacy has found its niche.  To ... soon be honored by SFBJ as the 2017 Power Leader ... to receive his award in October, Bardisa said of the ...
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, Inc. ... response letter from the U.S. Food and Drug Administration ... of sirukumab for the treatment of moderately to severely ... additional clinical data are needed to further evaluate the ... severely active RA. ...
(Date:9/19/2017)... LOUISVILLE, Ky. , Sept. 19, 2017   ZirMed ... and predictive analytics, today announced that it has been ranked ... the Black Book™ Rankings 2017 User Survey. ZirMed ... software solution for large hospitals and medical centers over 200 ... in Black Book,s healthcare technology user survey history. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... As health professionals work to improve their approach to healthcare, there is ... than filling out a survey; in many cases health professionals and patients are working ... and research on the importance of active engagement with patients and members of the ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a ... utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the ... a CBD form that can be easily incorporated into liquid products, while reducing costs ...
(Date:10/13/2017)... SAN LUIS OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... with Alzheimer’s or dementia. However, many long-term care insurance companies have a waiver for ... mean is the 90-day elimination period, when the family pays for care, is often ...
(Date:10/13/2017)... ... October 13, 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House ... most popular and least understood books in the Holy Scriptures, Revelation. The Book of ... baffled scholars for centuries. Many have tossed it off as mere rubbish, but Yisrayl ...
(Date:10/13/2017)... ... ... “America On The Brink”: the Christian history of the United States and ... of published author, William Nowers. Captain Nowers and his wife, Millie, have six ... years in the Navy. Following his career as a naval aviator and carrier ...
Breaking Medicine News(10 mins):