Troxatyl for the Treatment of Acute Myelogenous Leukemia & Blast CML

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Structural GenomiX Initiates Phase 2/3 Trial of Troxatyl for the Treatment

of Acute Myelogenous Leukemia

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SAN DIEGO, Aug. 16 /PRNewswire/ -- Privately held Structural GenomiX,

Inc., (SGX) announced today that the first patient has been enrolled in a

Phase 2/3 clinical trial of Troxatyl, a novel anti-cancer drug candidate

for treatment of acute myelogenous leukemia (AML). The study, with targeted

enrollment of 211 patients at approximately 40 trial centers in the United

States and Europe, is designed to establish the safety and effectiveness of

Troxatyl in patients with relapsed or refractory AML

(http://www.clinicaltrials.gov <http://www.clinicaltrials.gov/> ).

Francis Giles, M.D., Chief of Section, Developmental Therapeutics,

Department of Leukemia at the University of Texas M. D. Cancer

Center, is a Principal Investigator in the study. Dr. Giles commented, " My

M.

D. Cancer Center colleagues and I are very excited to be playing a

leadership role in the clinical development of Troxatyl for treatment of

AML.

Our initial clinical studies and additional recent work with this novel

investigational agent have demonstrated considerable promise for treatment

of

both AML and myelodysplastic syndromes, for which there are significant

unmet

medical needs. Among those needs, none are more pressing than in third-line

treatment of AML. We are delighted to have a study focused on this very

refractory population open for enrollment of our patients. "

The patients targeted in this Phase 2/3 study are those who are in

second

relapse with duration of second response less than 6 months, or who were

refractory to two previous courses of induction chemotherapy.

About Troxatyl

Troxatyl, a nucleoside analog, represents the first member of a new

class

of anti-cancer agents. Its unique chemical structure confers potential

advantages compared to existing AML therapy in that it is not subject to

common deactivating mechanisms that can cause resistance to existing

therapy.

In preclinical studies, Troxatyl has demonstrated broad activity against

both

solid tumors and hematologic malignancies. To date, approximately 700

patients have been treated in various Troxatyl Phase 1 and 2 studies in

which

delivery of the drug was by bolus intravenous (IV) injection. Promising

early

clinical results were observed in AML, myelodysplastic syndromes, blast

phase

chronic myelogenous leukemia, renal cell carcinoma, and pancreatic cancer

when

Troxatyl was administered via bolus IV injection.

Recent preclinical work has shown that Troxatyl administered as a

continuous IV infusion (CI) over 4 or 5 days results in significantly

increased drug exposure to the cancer cells. A presentation of data at ASCO

from a recently completed Phase 1/2 CI study of AML patients, most of whom

had

failed multiple chemotherapy regimens and in some cases bone marrow

transplantation, reported an overall response rate of 19 percent. Moreover,

the study demonstrated that a 50 percent greater dose of Troxatyl may be

safely administered via continuous infusion compared to the bolus IV

injection

route. The presentation also reported that the responding patients had a

median duration of response greater than 7 months. In this setting,

Troxatyl

had a manageable and transient toxicity profile and was well tolerated, even

in patients over the age of 60 who are typically less tolerant of existing

therapies than younger patients. A Phase 1/2 CI study in solid tumors is

currently enrolling pancreatic cancer patients

(http://www.clinicaltrials.gov <http://www.clinicaltrials.gov/> ).

About AML

AML is a hematopoietic stem cell disorder that is the most common form

of

acute leukemia, accounting for 80 to 90 percent of all acute leukemias in

adults. Although standard induction chemotherapy results in complete

remission in 50 to 75 percent of patients, relapse is common and long-term

survival rates remain at approximately 20 percent. At present, patients

with

relapsed or refractory AML have limited treatment options, underscoring the

need for new drugs in this challenging therapeutic area. A recently

published

review of M. D. 's historical experience with third-line therapy for

AML patients reports a less than 5 percent overall response rate with a 1 to

2

month average life expectancy, underscoring the unmet need in this patient

setting.

About SGX

SGX is a biotechnology company focused on the discovery and development

of

innovative cancer therapeutics. SGX's lead product candidate is Troxatyl, a

novel cancer therapeutic currently in Phase 2/3 clinical trials for the

treatment of Acute Myelogenous Leukemia and in Phase 1/2 clinical trials for

the treatment of various solid tumors. SGX has also developed a preclinical

pipeline of novel oncology therapeutics using SGX FAST technology, a

proprietary fragment-based approach to lead generation. The SGX preclinical

oncology pipeline comprises novel inhibitors of the Gleevec resistant

BCR-ABL

(including T315I) mutant 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 website at

http://www.stromix.com <http://www.stromix.com/> .

Forward-Looking Statements

This press release contains forward-looking statements, including those

relating to SGX's plans regarding a Phase 2/3 clinical trial of Troxatyl

and to advance Troxatyl for the treatment of AML. The clinical

development of investigational pharmaceutical products is subject to risks

and

uncertainties. There can be no assurance that SGX's investigational 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. There

can be no assurance that future clinical trials will confirm the preliminary

results referred to in this release or that Troxatyl will receive

regulatory approvals or prove to be commercially successful. 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.