Data Monitoring Committee Recommends Closing Enrollment in Recurrent Glioblastoma Study

Indianapolis (ots/PRNewswire) -

- Other Enzastaurin Trials Unaffected -

After reviewing data gathered to date, as part of a planned
interim analysis, an External Data Monitoring Committee (DMC) has
recommended that the STEERING trial (Study Evaluating Enzastaurin in
Recurrent Glioblastoma) be closed for enrollment. The global Phase
III study was evaluating enzastaurin for the treatment of an
aggressive and recurrent form of brain cancer.

Results of this planned interim analysis suggested that
enzastaurin would not meet the primary endpoint of improvement in
progression-free survival over an existing chemotherapy in this
particular study. Lilly accepted the DMC recommendation and
immediately contacted all STEERING study investigators to inform them
of the decision and to provide them all available information to
manage patients.

"We are disappointed for patients suffering from recurrent
glioblastoma, but we remain confident and committed to the
development of enzastaurin," said Richard Gaynor, M.D., vice
president, cancer research and global oncology platform leader for
Eli Lilly and Company. "Recurrent glioblastoma is a rare and
difficult to treat tumor and patients and their families are seeking
innovative treatment options. Given the independently validated
response rate of 22-percent in a phase II trial, we plan to
thoroughly review the data from this interim analysis and apply the
insights learned to the glioblastoma program. Based on preclinical
and clinical evidence, the company also remains fully committed to
the continued development of enzastaurin."

Enzastaurin is being evaluated in a Phase III trial (currently
enrolling patients) as a maintenance therapy for the treatment of
non-Hodgkin's lymphoma as well as being evaluated in several phase II
studies across a variety of more common tumor types including:
breast, colon, lung, ovarian and prostate cancers. These additional
trials are unaffected by the DMC recommendation.

Enzastaurin

Enzastaurin is a potent multi-kinase inhibitor which targets
selectively the PKCbeta and PI3/AKTsignaling pathways. By blocking
these key pathways frequently over-expressed in a wide variety of
cancers, enzastaurin suppresses tumor cell proliferation, induces
tumor cell death and inhibits tumor-induced angiogenesis. As further
evidence to the rare and unmet medical need of recurrent
glioblastoma, enzastaurin was granted orphan drug designation by the
European Agency for the Evaluation of Medicinal Products (EMEA) and
by the U.S. Food and Drug Administration's Office of Orphan Products
Development for the treatment of glioblastoma.

Background on STEERING Trial

The STEERING trial (Study Evaluating Enzastaurin in Recurrent
Glioblastoma) is a randomized, open label registration study in
recurrent glioblastoma multiforme (GBM) comparing the efficacy and
safety of enzastaurin, taken orally, versus CeeNU(R)
(lomustine[CCNU]), a chemotherapy used to treat this disease. The
primary endpoint is improvement in progression-free survival.

Glioblastoma

Glioblastoma is the most aggressive and malignant form of glioma,
a type of primary brain cancer. In the early stages, glioblastoma
tumors often grow quickly and without symptoms, becoming quite large
before signs of altered brain function arise. Surgery is generally
the first line of treatment, followed by radiation and/or
chemotherapy. Although primary treatment is often successful in
temporarily stopping the progression of the tumor, glioblastomas
almost always recur and survival rates remain low.

Data Monitoring Committee

A Data Monitoring Committee (DMC) is an independent body
consisting of physicians and statisticians. Their responsibility is
to review interim analysis data from clinical trials and make a
decision on whether the trial is still set up correctly or needs any
modifications.

Lilly Oncology, a Division of Eli Lilly and Company

For more than four decades, Lilly Oncology has been collaborating
with cancer researchers to deliver innovative treatment choices and
valuable programs to patients and physicians worldwide. Inspired by
the courageous patients living with cancer, Lilly Oncology is
providing treatments that are considered global standards of care and
developing a broad portfolio of novel targeted therapies to
accelerate the pace and progress of cancer care. To learn more about
Lilly's commitment to cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class pharmaceutical
products by applying the latest research from its own worldwide
laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, Ind., Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs. Additional information about Lilly
is available at www.lilly.com.

O-LLY

This press release contains forward-looking statements about the
potential of the investigational compound enzastaurin and reflects
Lilly's current beliefs. However, as with any pharmaceutical product
under development, there are substantial risks and uncertainties in
the process of development and regulatory review. There is no
guarantee that the product will receive regulatory approvals, or that
the regulatory approval will be for the indication(s) anticipated by
the company. There is also no guarantee that the product will prove
to be commercially successful. For further discussion of these and
other risks and uncertainties, see Lilly's filing with the United
States Securities and Exchange Commission. Lilly undertakes no duty
to update forward-looking statements.

CeeNU(R) (lomustine [CCNU], Bristol Myers Squibb)

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )

ots Originaltext: Eli Lilly and Company
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Christine Van Marter of Eli Lilly and Company, +1-317-651-1473,
vanmarterch@lilly.com /Photo: NewsCom:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO /PRN Photo
Desk, photodesk@prnewswire.com


	hier anmelden...