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Lilly Targeted Agent Shows Promise in Treating Primary Brain
Cancer
Investigational Oral, Targeted Agent Shrinks Tumor with Minimal Side Effects in
Glioblastoma
INDIANAPOLIS, May 17 /PRNewswire-FirstCall/ -- Preliminary results from a
Phase II clinical trial show patients with recurrent glioblastoma multiforme, a
form of primary brain cancer, experienced a significant tumor response rate
with minimal side effects when treated with enzastaurin, an oral, targeted
agent under development at Eli Lilly and Company (LLY).(1) Enzastaurin is the
first targeted agent of Lilly Oncology to enter into late stage clinical
development heralding a new phase of innovation for the group, which has
produced Gemzar(R) (gemcitabine HCl) and Alimta(R) (pemetrexed), two of the
world's leading chemotherapy agents.
"Recurring glioblastoma is a desperate disease for which there are very few
adequate treatments," said Howard Fine, M.D., chief of Neuro-Oncology at the
National Cancer Institute and lead author of the study, which was presented
today at the annual meeting of the American Society of Clinical Oncology
(ASCO).
Glioblastoma, a type of brain cancer, is part of the larger group of tumors
that impact the central nervous system, known as gliomas. Patients with highly
recurrent glioblastoma are usually at a more advanced stage of the disease and
correspondingly may face altered brain function or death due to the tumor's
rapid growth rate. Radiation therapy is the most effective treatment following
surgery. Almost all patients receive some form of radiation therapy. Gliomas
-- tumors of the brain -- are among the most angiogenic of all tumors, meaning
the tumor has the ability to grow by drawing on blood from surrounding vessels
at a very rapid rate. The inhibition of tumor angiogensis may offer the
potential as a highly effective form of therapy.
The Phase II study presented at ASCO included 92 patients with recurrent
glioblastoma who had failed more than one prior regimen of chemotherapy.
Patients' treatment consisted of an oral fixed dose of 500 mg of enzastaurin,
administered daily. Treatment was allowed to continue indefinitely depending
upon the patient's response to the drug.
Results show that tumor shrinkage was evident in patients who received
enzastaurin, with a corresponding response rate of 20 - 25 percent. Overall,
enzastaurin was well tolerated in this patient population and clinical results
show that patients experienced minimal side effects while administered
enzastaurin. The most common side effect was thrombocytopenia, which is a low
platelet count.
"Enzastaurin's mode of action is unique because it impacts tumor cells in
multiple ways, while other targeted agents act on one pathway," said Richard
Gaynor, M.D., vice president of cancer research and clinical investigation at
Lilly.
Gaynor said that in the trial enzastaurin stopped the flow of blood to
patients' tumors, resulting in disruption of tumor growth and -- in most cases
-- tumor shrinkage. In addition to prohibiting angiogenesis of tumor cells,
enzastaurin inhibits the cell pathway signaling through the PKC-beta and Pl3
kinase/AKT pathways, two of the pathways that are vital to the survival of
tumor cells.(2) These pathways are frequently activated in glioblastoma and
because cancer cells don't follow the checks and balances seen in normal cells,
the tumors grow unchecked. Furthermore, tumor-induced angiogenesis requires
activation of these pathways. Enzastaurin causes tumor cells to turn off those
survival signals. Consequently, enzastaurin has both direct tumor cell killing
effects (apoptosis) and indirect, tumor-starving effects (antiangiogensis) said
Gaynor.
Gaynor said final results from the Phase II study are expected by 2006 and
Lilly is currently designing the protocol for the Phase III study of
enzastaurin in recurrent glioblastoma. The Phase III study will further verify
the efficacy and safety of the drug in a larger patient population.
About Glioblastoma
Glioblastoma is the most aggressive and malignant form of glioma, a type of
primary brain cancer. Surgery is often used to treat gliomas, along with
radiation. However, since surgery and radiation fail to cure the disease,
doctors may turn to additional radiation or chemotherapy. In early stages
glioblastoma tumors often grow without symptoms and therefore can become quite
large before symptoms arise. When the tumor becomes symptomatic, tumor growth
is usually very rapid and is accompanied by altered brain function, and if left
untreated the disease becomes lethal. Although primary treatment is often
successful in temporarily stopping the progression of the tumor, glioblastomas
almost always recur and become lethal.
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 http://www.lilly.com/ . P-LLY
This press release contains forward-looking statements about the potential of
the investigational compound enzastaurin (LY-317615) 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.
Enzastaurin (LY-317615, Lilly)
Gemzar(R) (gemcitabine HCl), Lilly
Alimta(R) (pemetrexed), Lilly
(1) Results from a phase II trial of Enzastaurin HCl (LY317615) in patients
with recurrent high grade gliomas; H. Fine, L. Kim, C. Royce, D. Draper, I.
Haggarty, H. Elinzano, D. Thorton
(2) Results from clinical trial: The PKC-Beta selective inhibitor, Enzastaurin
HCl (LY317615), suppresses GSK3Beat phosphorylation, induces apoptosis and
suppresses growth of human colon cancer and glioblastoma xenografts; J. Graff,
A. McNulty, K. Hanna, B. Konicek, R. Lynch, S. Bailey
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
DATASOURCE: Eli Lilly and Company
CONTACT: Gregory L. Clarke (U.S. Media), +1-317-276-5222, pager:
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of Eli Lilly and Company