Telomerase Inhibitor Drug (GRN163L)

Chronic Lymphoproliferative Disease

We have initiated a Phase I/II, dose-escalation trial of GRN163L in patients with Chronic Lymphoproliferative Disease. The trial is primarily designed to demonstrate the safety and tolerability of GRN163L administered intravenously on a weekly basis. Importantly, Chronic Lymphoproliferative Disease also provides a unique opportunity to measure both the magnitude and time course of telomerase inhibition in tumor cells achieved at various doses of GRN163L. By serially assessing the effects of the drug on the target enzyme in cells, insights will be gained regarding the dose and dosing interval that optimally inhibits telomerase activity in the tumor. In this way, pharmacokinetic and pharmacodynamic parameters can be correlated with any observed reduction in patients' tumor burden.

This trial is open for patient enrollment at the following sites:

Long Island Jewish Medical Center
New Hyde Park, NY
Yin Yin Chi
Telephone: 718-470-4744

Weill Medical College of Cornell University
New York, NY
Jennifer Horn
Telephone: 212-746-2652

The Ohio State University Medical Center
Columbus, OH
Sharon Waymer, LPN
Telephone: 614-293-9712

Roswell Park Cancer Institute
Buffalo, NY
Amy Whitworth
Telephone: 716-845-8965

University of Texas Southwestern
Harold C. Simmons Comprehensive Cancer Center
Dallas, TX
Tracee Rainey, RN
Telephone: 214-648-5102

This Phase I, dose-escalation trial of GRN163L is primarily designed to demonstrate the safety and tolerability of GRN163L administered intravenously (IV) on different schedules in patients with refractory or relapsed solid tumor malignancies. This study will also enable an assessment of the pharmacokinetic profile of GRN163L at escalating doses. A secondary endpoint of the trial is the preliminary evaluation of anti-tumor activity of GRN163L in this patient population.

This trial is open for patient enrollment at the following sites:

The University of Chicago Medical Center
Chicago, IL
Linda Janisch, RN, MS, OCN
Telephone: 773-702-1612

Wayne State University
Karmanos Cancer Center
Detroit, MI
Amie Anderson
Telephone: 313-576-9385

This Phase I/II study in patients with advanced non-small cell lung cancer (NSCLC) is designed to determine the safety and maximum tolerated dose of GRN163L when administered intravenously in combination with a standard paclitaxel and carboplatin regimen.

The trial is open for patient enrollment at the following sites:

University of Texas
Simmons Comprehensive Cancer Center
Dallas, TX
Erin Fenske
Telephone: 214-648-1688

University of Wisconsin
Madison, WI
Sarah Marcotte
Telephone: 608-262-8158

University of Maryland Greenebaum Cancer Center
Baltimore, MD
R. Zak, RN, M.Ed.
Telephone: 410 328-9166

MD Anderson Cancer Center
Houston, TX
Roy Herbst, MD, PhD
Telephone: 713-792-6363

Geron has initiated two clinical trials in patients with multiple myeloma.

The first is a Phase I/II study to determine the safety and maximum tolerated dose (MTD) of GRN163L when administered intravenously in patients with multiple myeloma who have received at least two prior regimens of treatment.

The trial is open for patient enrollment at the following sites:

H. Lee Moffitt Cancer Center and Research Institute
Tampa, FL
Luz Diez
Telephone: 813-745-4625

Roswell Park Cancer Institute
Buffalo, NY
Dawn DePaolo
Telephone: 716-845-3824

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore, MD
Dionne Savage, RN, BSN
Telephone: 410-614-0382

Dana Farber Cancer Institute
Boston, MA
Nikhil Munshi, MD
Telephone: 617-632-4218

The second clinical trial is a Phase I dose escalation study to determine the safety, maximum tolerated dose (MTD) and objective response rate of GRN163L when administered intravenously in combination with bortezomib (Velcade^®) with and without dexamethasone in patients with relapsed and refractory disease.

The trial is open for enrollment at the following site:

Fred Hutchinson Cancer Research Center
Seattle, WA
Kathy Lilleby
Telephone: 206-667-5836

The primary objective of the Phase I/II, dose escalation study is to determine the safety, maximum tolerated dose (MTD) and objective response rate of GRN163L when administered intravenously in combination with a paclitaxel/bevacizumab regimen.

The trial is open for patient enrollment at the following sites:

Melvin and Bren Simon Cancer Center at Indiana University
Indianapolis, IN
Kathy D. Miller, MD
Telephone: 317-274-1690