SAN DIEGO and LAVAL, Quebec, July 29 /PRNewswire/ -- SGX (Structural GenomiX, Inc.) and Shire (Shire BioChem, Inc.), today announced that SGX has acquired worldwide rights from Shire to Troxatyl(R), an anti-cancer agent currently in Phase 1/2 clinical trials for the treatment of acute myelogenous leukemia (AML). Based on promising interim clinical data, SGX plans to complete the ongoing Phase 1/2 studies and progress Troxatyl(R) into Phase 2 early in 2005.
“With this transaction, SGX is executing on its strategic objective of in-licensing high quality product candidates to complement our developing oncology pipeline, which includes preclinical programs in leukemias, urological cancers and other solid tumors,” said Stephen K. Burley M.D., D.Phil., chief scientific officer of SGX. “The in-licensing of Troxatyl(R) allows us to accelerate the development of our oncology franchise as we continue advancing to the clinic the compounds discovered with our proprietary FAST(TM) lead generation technology.”
“Given the rapid rate of relapse of virtually all AML patients, there is a pressing need for a more effective therapy for these patients,” added Dr. Burley. “The existing safety and efficacy data on Troxatyl(R) from the current trials indicates the potential for rapidly moving this program through further clinical trials and subsequently to the market to address critical unmet medical needs.”
Said Matthew Emmens, Shire’s chief executive officer: “Our strategy focuses our business on core therapeutic areas in markets where we can build leading competitive positions. The out-licensing of Troxatyl(R) is part of this refocus. SGX has the expertise to progress this cancer treatment and give it full support in the market in order to maximize the potential of the product and the return to Shire.”
Under the terms of the agreement, SGX will make an upfront payment, milestone payments based on successful development and approval of Troxatyl(R) and will also make royalty payments based on net sales.
About Troxatyl(R)
Troxatyl(R) represents a new class of anti-cancer agents. Its unique structure confers some important advantages compared to existing therapies such as cytarabine and gemcitibine; in particular it is not subject to common deactivating mechanisms that can rapidly cause resistance to existing therapies. In preclinical studies, Troxatyl(R) has demonstrated broad activity against both solid tumors and hematological malignancies. To date, approximately 700 patients have been treated in various Troxatyl(R) Phase 1/2 studies where delivery of the drug was by bolus intravenous (IV) administration. The most promising early clinical results were observed in an AML study when Troxatyl(R) was given by IV bolus administration. More recent studies have shown that Troxatyl(R) is even more effective when administered IV as a continuous infusion (CI) over 4 or 5 days, resulting in significantly increased exposure to the cancer cells. An ongoing Phase 1/2 CI study of AML patients who have failed two or more chemotherapy regimens and in some cases bone marrow transplantations has shown very promising results, demonstrating that CI administration can give significantly improved response rates compared to IV bolus administration. A Phase 1/2 study in solid tumors is also in progress.
Other studies have shown the potential for Troxatyl(R) treatment of other hematological cancers, including blast phase chronic myelogenous leukemia (CML) and myeloid dysplastic syndrome (MDS), and in various solid tumors.
About AML
AML is a hematopoietic stem cell disorder that is the most common form of leukemia, accounting for approximately 90 percent of all acute leukemias in adults. Although induction chemotherapy results in complete remission in 50-75 percent of patients, relapse is very common and long-term survival rates remain at less than 20 percent. Unfortunately, patients with relapsed AML at present have very limited treatment options pointing out the need for the development of new agents in this area.
About SGX
SGX is a drug discovery and development company accelerating the discovery of novel therapeutics to treat human diseases. SGX is developing a pipeline of preclinical programs in oncology from the application of its fragment-based lead discovery technology: FAST(TM). FAST(TM) relies on libraries of synthetically enabled fragments developed by SGX, to ensure rapid hit-to-lead optimization and draws on SGX expertise in high-throughput co-crystallography, state of the art computational scoring and automated parallel synthesis. SGX utilizes FAST(TM) on programs focused in oncology as well as partnered programs in other disease areas. The Company is based in San Diego, California. For more information, please visit our website at http://www.stromix.com/.
About Shire
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world’s key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US. For further information on Shire, please visit the Company’s website: http://www.shire.com/
Forward-Looking Statements
This press release contains forward-looking statements, including those relating to SGX’s plan to advance Troxatyl(R) initially for the treatment of AML, and SGX’s plans to complete the current Phase 1/2 trial and initiate Phase 2 trials in early 2005. The clinical development of investigational pharmaceutical products is subject to risks and uncertainties. There can be no assurance that SGX’s studies of any of its product candidates can be conducted within the time frame that the company expects, or that the studies will yield positive results. For further discussion of these and other risks and uncertainties, see the various disclosures made by SGX. SGX undertakes no duty to update forward-looking statements.
Structural GenomiX, Inc.
CONTACT: Herbert G. Mutter, Vice President, Finance of SGX,+1-858-228-1565, herb_mutter@stromix.com; or media, Jason Spark of Atkins +Associates, +1-858-527-3491, jspark@irpr.com, for SGX
Web site: http://www.shire.com/
Web site: http://www.stromix.com/
