DUBLIN, Calif., Jan 05, 2011 (BUSINESS WIRE) --
SuperGen, Inc. (NASDAQ:SUPG) today announced that it has enrolled the first patient in its first in human study of SGI-110, a second-generation hypomethylating agent, in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML).
SGI-110 was discovered and developed internally at SuperGen. The phase I study will be conducted in two stages. In the initial stage, patients will receive escalating doses of SGI-110 until the maximum tolerated dose (MTD) or the biologically effective dose (BED) is determined. Patients will be randomized to receive one of two dosing schedules of either a daily subcutaneous injection for 5 days, or a single weekly subcutaneous injection for 3 injections, both in a 28 day cycle. The second stage will include expansion of the number of patients treated at the selected dosing schedule to better evaluate both efficacy and safety in MDS and AML patients.
"We are pleased with the advancement of SGI-110 into the clinical stage. Moreover, we are honored to work with a group of highly distinguished collaborators, including members of the Stand Up to Cancer Epigenetics Dream Team, in the development of this important new agent," said Mohammad Azab, M.D., Chief Medical Officer.
A summary of preclinical efficacy, safety, and pharmacokinetics data of SGI-110 was presented at the recent American Society of Hematology conference. A downloadable copy of the poster can be found in the Pipeline section of the Company's website, http://www.supergen.com.
SGI-110 is a small molecule, DNA hypomethylating agent. It is intended to follow up on the Company's currently marketed product, Dacogen® (decitabine) for Injection that is licensed and marketed by Eisai and Cilag GmbH International, a member of the Johnson & Johnson family of companies. In preclinical studies, SGI-110 has shown potential to be administered with dosing schedules less frequent than currently marketed products. SuperGen is working with the Epigenetics Dream Team from Stand Up to Cancer to develop this drug. The goal of this Dream Team is to bring the promise of epigenetic therapy to clinical practice in the treatment of leukemia, breast, colon and lung cancers.
SuperGen is a pharmaceutical company dedicated to the discovery and development of novel cancer therapeutics in epigenetic and cell signaling modulation. The Company develops products through biochemical and clinical proof of concept to partner for further development and commercialization. For more information about SuperGen, please visit http://www.supergen.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause the company's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the overall success of the Phase I trial protocol for SGI-110, our ability to discover, develop and move target compounds into clinical development and other risks and uncertainties detailed from time to time in the company's filings with the Securities and Exchange Commission including its most recently filed Form 10-Q and 10-K. SuperGen, Inc. undertakes no duty to update any of these forward-looking statements to conform them to actual results.
SOURCE: SuperGen, Inc.
Timothy L. Enns, 925-560-2810
Senior Vice President
Corporate Communications & Business Development
Susanna Chau, 925-560-2845