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Structural GenomiX Receives $48.5 Million Award From NIH

Award Part of $300 Million NIH Funding Initiative for Protein Structure Research

SAN DIEGO, July 1 /PRNewswire/ -- Privately-held Structural GenomiX, Inc. (SGX) today announced receipt of a $48.5 million National Institutes of Health (NIH) Cooperative Agreement Award from the National Institute of General Medical Sciences (NIGMS) www.nigms.nih.gov. The award is one of ten the NIH announced today as part of its Protein Structure Initiative (PSI), which aims to facilitate the discovery of the three-dimensional structures of proteins to help reveal their role in disease and aid in the design of new medicines.

The NIH award provides five years of renewed funding for a consortium administered by SGX, the New York Structural GenomiX Research Consortium (NYSGXRC) (www.nysgxrc.org). SGX expects to retain approximately 50 percent of the funding with the remainder to be distributed to institution collaborators. The NYSGXRC is an internationally-recognized, industry-academic structural genomics center that was established by Dr. Stephen K. Burley, SGX's chief scientific officer and senior vice president, during the pilot study phase of the PSI. Additional participants in the NYSGXRC include scientists at Albert Einstein College of Medicine, Brookhaven National Laboratory, Columbia University, and the University of California at San Francisco.

"We are partnering with some of the finest medical research institutions in the world," commented Burley.

Under Dr. Burley as principal investigator, SGX will lead the overall research efforts under this NIH Award and will be responsible for primary oversight and administration of activities by the institution collaborators, as well as all gene cloning and expression, purification, and biophysical characterization of target proteins. SGX will use its proprietary technology platform to produce high quality and well characterized proteins for crystallization and structure determination. In addition, SGX will provide access to its state-of-the-art X-ray beamline at the Advanced Photon Source, Argonne National Laboratory for structure determination efforts.

"We are pleased that SGX's comprehensive protein structure research efforts to date laid the groundwork for this NIH award," stated Dr. Burley. "Understanding of protein structures plays an integral role in comprehending complex biological systems and in developing the next generation of drug targets and medicines. This award gives SGX an unprecedented opportunity to favorably impact both basic biomedical research and the drug discovery process."

About SGX

SGX discovers and develops innovative cancer therapeutics. SGX's lead product candidate is Troxatyl(TM), a novel cancer therapeutic currently in Phase 2/3 clinical trials for the treatment of Acute Myelogenous Leukemia and in Phase 1/2 studies for various solid tumors. SGX has also developed a preclinical pipeline of novel oncology therapeutics using SGX FAST(TM) technology, a proprietary fragment-based approach to lead generation. The SGX preclinical oncology pipeline comprises novel inhibitors of wild-type and Gleevec® resistant mutants of BCR-ABL (importantly, T315I) and dual specificity inhibitors of the MET-RON receptor tyrosine kinases. SGX is also pursuing a broad program of fragment-based lead generation directed against a portfolio of validated oncology targets that include HSP-90 and the Aurora kinases. SGX has secured revenue generating drug discovery and development partnerships with leading pharmaceutical and biotechnology companies including Eli Lilly, Serono S.A., and Roche. For more information, please visit the company's website at www.stromix.com.

About the NIGMS Protein Structure Initiative

For more information about the NIGMS Protein Structure Initiative, visit http://www.nigms.nih.gov/psi/

Forward-Looking Statement

This press release contains forward-looking statements that may relate to future events or SGX's future performance. We cannot guarantee future events or performance, which may differ materially from our expectations. We urge you to carefully review and consider the various disclosures made by us that describe some of the factors that affect our business and may cause such material differences.

CONTACT: Annette North, L.L.B., Vice President, Legal Affairs of SGX, +1-858-228-1530, [email protected]; or Media, Jason Spark of Atkins + Associates, +1-858-527-3491, [email protected], for SGX

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Source: Structural GenomiX, Inc

FDA Grants Orphan Drug Designation for Troxatyl (Troxacitabine)

SAN DIEGO, CA -- May 12, 2005 -- Structural GenomiX, Inc. (SGX) announced today that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration for its lead product candidate, Troxatyl" (troxacitabine), for the treatment of acute myelogenous leukemia (AML).

Troxatyl is a novel nucleoside analog that is currently being evaluated by the Company in a Phase 1/2 trial for the treatment of relapsed AML and in a Phase 1/2 trial for the treatment of various solid tumors. The Company plans to complete the Phase 1/2 AML trial and progress Troxatyl into a Phase 2 trial in relapsed and/or refractory adult AML patients in mid 2005.

Preliminary data from the Company's Phase 1/2 AML trial will be presented in a poster session at the American Society of Clinical Oncology (ASCO) 2005 Annual Meeting in Orlando, Florida.

Orphan Drug Designation provides the sponsor of an orphan drug product with eligibility for: seven year marketing exclusivity following marketing approval; tax credits for clinical research; reduced NDA filing fees; grants for further clinical research and development; and assistance with the review of clinical trials protocols.

About Troxatyl

Troxatyl is an anti-cancer agent currently in Phase 1/2 acute myelogenous leukemia (AML) clinical trials. SGX plans to complete the ongoing Phase 1/2 studies and progress Troxatyl into Phase 2 in mid 2005. Over 600 patients have received Troxatyl in various Phase 1 and 2 studies where delivery of the drug was by bolus intravenous (IV) administration. Preclinical studies have shown that continuous IV infusion results in a significant increase in exposure of cancer cells to Troxatyl. Evaluation of Troxatyl administered by continuous IV infusion in patients is currently ongoing in clinical studies.

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.

SOURCE: Structural GenomiX, Inc.

FDA Approvals: Orphan Drugs Troxatyl, Tilarginine Acetate, Aerosolized Gene Therapy

Yael Waknine

June 24, 2005 The U.S. Food and Drug Administration (FDA) has approved orphan drugs troxacitabine injection for the treatment of acute myelogenous leukemia, tilarginine acetate injection for the treatment of cardiogenic shock, and a compacted nonviral DNA vector mist for the treatment of cystic fibrosis.

Orphan Drug Troxacitabine (Troxatyl) for Acute Myelogenous Leukemia

On April 4, the FDA approved orphan drug troxacitabine (Troxatyl injection, made by Structural GenomiX, Inc.) for the treatment of acute myelogenous leukemia (AML).

Preliminary clinical data from a phase 1/2 trial in 48 patients with refractory or relapsed AML have shown the nucleoside analog to be well tolerated; no grade 3/4 toxicities were observed in 18 patients receiving the maximum tolerated dose of 60 mg/m2 via continuous infusion for five days.

Treatment with troxacitabine induced an overall response rate of 17% and response duration of six months or longer, representing a significant improvement over prior therapies that have typically yielded a 5% response rate with a one- to two-month average life expectancy in this heavily pretreated population.

The favorable response and duration activity are considered to be a result of the continuous infusion approach that enables patients to tolerate an approximate 50% increase in dose compared with bolus infusion. Continuous infusion was shown to significantly increase cancer cell exposure to the drug in preclinical studies.

The company will be initiating a pivotal phase 2 clinical study of troxacitabine in second relapse/second salvage high-risk AML patients later this year. Other indications for troxacitabine currently under investigation include myelodysplastic syndrome and various solid tumors.

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