Systems Medicine, Inc. (SMi) develops oncology products by integrating predictive cellular pharmacogenomics (“omics”) with world-class clinical and regulatory expertise. This allows SMi to
develop patient-selective therapies by defining the “context-of-vulnerability” of cancer and treating only those patients most likely to respond to specific drugs or drug combinations. The Company's
business plan is to acquire clinical stage products, assess the context-of-vulnerability for those drugs, and optimally position those drugs for success in clinical development and commercial use.
People:
SMi has assembled a world-class team of genomic-based clinical oncologists, translational drug developers, and business executives that uniquely position SMi as an
oncology company. The core of SMi's team founded ILEX Oncology, which was acquired for $1.0 billion in 2005. Dr's. Daniel Von Hoff (founder of ILEX) and Steve
Weitman, both renowned medical oncologists, lead SMi's clinical group. They are supported by an extensive network of industrial, academic, and regulatory-based
oncologists. Dr's. Jeffrey Trent and Spyro Mousses lead the genomic-based translational efforts. Drs. Robert MacArthur and Patrick Shannon lead the drug development and
regulatory affairs team. Mr. Richard Love, founder of ILEX, is Chairman of the Company. Mr. Jeffrey Jacob, a former senior executive at Research Corporation Technologies,
Inc., serves as CEO and President and Mr. Timothy Williamson, a veteran of business development in large, mid, and small biotech/pharmaceutical companies serves as Chief
Business Officer.
Products:
The Company has in-licensed, and is presently developing, a novel Phase II compound for multiple oncology indications which include genomic-based patient selection.
In addition, SMi is in negotiation with multiple pharmaceutical companies to partner additional clinical stage compounds. The Company also has an ongoing pre-clinical
program to develop a highly specific Src-inhibitor (SMi-11958), derived from a proprietary class of new compositions invented at MD Anderson Cancer Center.
Platform:
SMi's OncoLethal Engine™, or “OLE”, utilizes a systems biology approach to discover, understand, and exploit the vulnerabilities that arise in
cells during, and because of, the cancer process. Specific cutting edge “omics” tools, such as high-throughput RNAi profiling supported by powerful
bioinformatics, are the core of the OLE platform. The key to the platform is SMi's ability to integrate these tools into world-class clinical development,
translational drug development, and diagnostics to help identify and select patient populations that will be specifically responsive to SMi’s drugs.
Partnering:
As a result of its highly respected people and its unique platform, SMi is in a preferred position for partnering with large pharma and biotech companies. SMi offers
potential partners the opportunity to recast their clinical development programs with focused clinical-based genomics programs, allowing them to reposition their drugs as
“molecular-based” therapeutics. SMi's team provides a “one-stop shop” to facilitate patient screening-based development, as well as the
regulatory nuances of a “personalized medicine” approach.
Call for Investors:
SMi seeks to raise $25MM-$30MM in a financing targeted for late 2006. This will enable SMi to pursue key milestones for SMi-BX1 such as: a) completion of a Phase II
sarcoma trial (in life), b) completion of a Phase IIa GIST trial, c) completion of a Phase I study of SMi-BX1 drug combinations, and d) initiation of a Phase II
“context-of-vulnerability” trial. SMi also plans to file an IND and initiate clinical studies for its lead Src inhibitor, as well as close at least one new clinical stage drug
development partnership. The proceeds will also allow the Company to complete its new OncoLethal EngineTM facility.