Geron Corporation (Nasdaq:GERN) today announced the final results of two Phase 1 clinical trials of GRN1005, the company’s lead LRP-directed peptide-drug conjugate (LRP-directed PDC), in patients with brain metastases from solid tumors and patients with malignant glioma, demonstrating preliminary but encouraging single agent clinical activity in both indications. Geron expects to initiate two Phase 2 clinical trials of GRN1005 before the end of the year in patients with brain metastases arising from breast cancer (Study GRN1005 Against Brain Metastases – Breast Cancer; GRABM-B) or non-small cell lung cancer (Study GRN1005 Against Brain Metastases – Lung Cancer; GRABM-L).
The final results from the Phase 1 studies of GRN1005 were presented at the 2011 AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics in San Francisco, CA.
“Geron’s focus is on innovative anti-cancer therapies that can have a significant impact on patient outcomes. Cancer in the brain currently represents a substantial unmet medical need, because drugs that might be effective against those tumors are not able to efficiently cross the blood-brain barrier and enter the tumor,” said Stephen M. Kelsey, M.D., Geron’s Executive Vice President, Head of R&D and Chief Medical Officer. “The Phase 1 data showed that GRN1005 can penetrate brain tissue and brain tumors in patients, and is well tolerated, with encouraging evidence of anti-tumor activity against brain metastases. Importantly, GRN1005 also has activity against cancers outside the brain, and so may control extra-cranial disease, which may be cause of death in patients who have brain metastases. We expect to initiate our Phase 2 program before the end of the year with the dosing of a first patient in our clinical trial of brain metastases from breast cancer.”
Phase 1 Trial DesignsGRN1005 (previously known as ANG1005) is the conjugation of the cytotoxic drug paclitaxel to an LRP-directed peptide (Angiopep-2). GRN1005 was evaluated in two separate Phase 1 multi-center, open-label, dose escalation clinical trials, conducted by Angiochem, Inc., to identify the maximum tolerated dose (MTD) and obtain data on safety and tolerability, and preliminary evidence of anti-tumor activity in patients with heavily pre-treated progressing, advance-stage solid tumors and brain metastases (n=56; including breast, lung, skin and ovarian cancer) and in patients with recurrent or progressive malignant glioma (n=63; glioblastoma multiforme, anaplastic glioma, astrocytoma ependymoma).