EpiCept Announces Initiation of Phase 2B Study of Azixa(TM) for Front-Line Treatment of Glioblastoma Multiforme by Myrexis
12:01a ET December 28, 2010 (Business Wire)
Regulatory News:
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) today reported that Myrexis, Inc. has initiated a controlled two-arm Phase 2b clinical study of Azixa(TM) as a front-line treatment for glioblastoma multiforme (GBM). Azixa(TM), a vascular disruption agent with potent anti-cancer activity, was discovered by EpiCept as part of its ASAP technology platform and licensed to Myrexis.
The study will enroll up to 120 newly-diagnosed GBM patients at treatment centers in the United States and India in order to evaluate Azixa(TM) combination therapy as a first-line GBM treatment. The trial will compare standard of care in this disease with standard of care in combination with Azixa(TM).
"We are pleased that Myrexis is continuing to evaluate Azixa and that they continue to see promise for the compound in a devastating disease for which current therapy is inadequate," said Jack Talley, President and Chief Executive Officer of EpiCept. "We expect them to continue to move the product candidate forward towards registration in the United States."
Azixa(TM) is currently being evaluated in other Phase II trials. In June 2010, Myrexis reported results from two of the Phase II trials, in metastatic melanoma in combination with temozolomide and in recurrent glioblastoma in combination with carboplatin, at the annual meeting of the American Society for Clinical Oncology (ASCO). Updated results from an ongoing, open-label Phase 2a monotherapy study of Azixa(TM) in treatment-experienced patients with glioblastoma multiforme (GBM) were presented in November 2010, and data from a sub-group of patients with recurrent GBM who are naive to Avastin is expected to be reported in the first half of 2011.
As one of the molecules within the EpiCept EP90745 series of apoptosis inducer compounds intended for the treatment of cancer, Azixa(TM) was discovered through the Company's Anti-cancer Screening Apoptosis Platform (ASAP). In December 2003, EpiCept granted an exclusive, worldwide development and commercialization agreement for the EP90745 series (which includes Azixa(TM)) to Myrexis, which assumed responsibility for the clinical development and commercialization of this series of compounds. The license agreement requires Myrexis to make milestone payments and pay license fees as well as a royalty to EpiCept on sales of EP90745-related products, assuming successful commercialization of any compound within the EP90745 series. The dosing of the first patient in a Phase III or equivalent trial intended to be used for registration purposes for Azixa(TM) triggers a milestone payment to EpiCept.
About EpiCept Corporation
EpiCept is focused on the development and commercialization of pharmaceutical products for the treatment of cancer and pain. The Company's lead product is Ceplene(R), approved in the EU for the remission maintenance and prevention of relapse in adult patients with Acute Myeloid Leukemia (AML) in first remission. In the U.S., a pivotal trial is scheduled to commence in 2011. The Company has two other oncology drug candidates currently in clinical development that were discovered using in-house technology and have been shown to act as vascular disruption agents in a variety of solid tumors. The Company's pain portfolio includes EpiCept(TM) NP-1, a prescription topical analgesic cream in late-stage clinical development designed to provide effective long-term relief of pain associated with peripheral neuropathies.
Forward-Looking Statements
This news release and any oral statements made with respect to the information contained in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements that express plans, anticipation, intent, contingency, goals, targets, future development and are otherwise not statements of historical fact. These statements are based on our current expectations and are subject to risks and uncertainties that could cause actual results or developments to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Factors that may cause actual results or developments to differ materially include: the risk that Azixa(TM) will not receive regulatory approval or achieve significant commercial success, the risk that we will not receive any significant payments under our agreement with Myrexis, the risk that the development of our other apoptosis product candidates will not be successful; the risk that Ceplene(R) will not receive regulatory approval or marketing authorization in the United States, the risk that Ceplene(R) will not achieve significant commercial success, the risk that any required post-approval clinical study for Ceplene(R) will not be successful, the risk that we will not be able to maintain our final regulatory approval or marketing authorization for Ceplene(R), the risk that future financing will not successfully close or that the proceeds thereof will be materially less than anticipated, the risks associated with the adequacy of our existing cash resources and our ability to continue as a going concern, the risks associated with our ability to continue to meet our obligations under our existing debt agreements, the risk that clinical trials for EpiCept(TM) NP-1 or crolibulin(TM) will not be successful, the risk that EpiCept(TM) NP-1 or crolibulin(TM) will not receive regulatory approval or achieve significant commercial success, the risk that we will not be able to find a partner to help conduct the Phase III trials for EpiCept(TM) NP-1 on attractive terms, a timely basis or at all, the risk that our other product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later stage clinical trials, the risk that we will not obtain approval to market any of our product candidates, the risks associated with dependence upon key personnel, the risks associated with reliance on collaborative partners and others for further clinical trials, development, manufacturing and commercialization of our product candidates; the cost, delays and uncertainties associated with our scientific research, product development, clinical trials and regulatory approval process; our history of operating losses since our inception; the highly competitive nature of our business; risks associated with litigation; the risk that our securities may be delisted from Nasdaq; and risks associated with our ability to protect our intellectual property. These factors and other material risks are more fully discussed in our periodic reports, including our reports on Forms 8-K, 10-Q and 10-K and other filings with the U.S. Securities and Exchange Commission. You are urged to carefully review and consider the disclosures found in our filings which are available at www.sec.gov or at www.epicept.com. You are cautioned not to place undue reliance on any forward-looking statements, any of which could turn out to be wrong due to inaccurate assumptions, unknown risks or uncertainties or other risk factors.
*Azixa is a registered trademark of Myrexis, Inc.
EPCT-GEN
SOURCE: EpiCept Corporation
EpiCept Corporation:
Robert W. Cook, 914-606-3500
rcook@epicept.com
or
Media:
Feinstein Kean Healthcare
Greg Kelley, 617-577-8110
gregory.kelley@fkhealth.com
or
Investors:
Lippert/Heilshorn & Associates
Kim Sutton Golodetz, 212-838-3777
kgolodetz@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
