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news.Sangamo BioSciences (Sangamo) has initiated two new clinical trials of ZFP Therapeutics, a phase 2b study in diabetic neuropathy (DN) and a phase 1 trial in glioblastoma. The company has also received renewal of $3m in funding for the phase 2b trial by the Juvenile Diabetes Research Foundation International (JDRF).
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Edward Lanphier, president and CEO of Sangamo, said: “We enter 2010 with a strong balance sheet and a robust clinical pipeline. With the initiation of these two new clinical trials, we continue to increase the value, maturity and visibility of our novel drug development platform.”
“We are developing our lead therapeutic, SB-509, for neurological indications including DN and ALS. The data generated to date in DN, our most advanced program, provide direct histologic evidence of nerve regrowth with SB-509 treatment and a mechanistic proof of concept for its neuroregenerative effects. Our enthusiasm for the potential and importance of this drug is shared by JDRF who, after extensive review of the clinical data, has committed to fund a further $3.0m of development costs for this new Phase 2b trial. While we continue active discussions with potential corporate partners, timely initiation of this trial enables us to maximize the future value of this program. Finally, the Phase 1 glioblastoma trial is our third ZFP Therapeutic and the second zinc finger nuclease (ZFN)-based program to enter the clinic and we are pleased to have achieved this significant milestone.”
The phase 1 glioblastoma trial will be initiated by Sangamo’s collaborators at City of Hope. It is designed to evaluate the safety and tolerability of a modified CD8+ cytotoxic T lymphocyte (CTL) product that has been made resistant to glucocorticoid steroids using Sangamo’s ZFP nuclease ZFN-based technology. The study will accrue subjects with recurrent/refractory malignant glioblastoma multiforme (GBM). The FDA has reviewed and accepted an Investigational New Drug (IND) application to initiate this open-label, multi-dosing phase 1 clinical trial.
Michael Jensen, associate chair for department of cancer immunotherapeutics and tumor immunology, City of Hope, said: “We look forward to initiating this study to evaluate a promising therapeutic approach for the treatment of malignant brain tumors for which there are currently few effective therapeutic options after surgery.
“In collaboration with Sangamo, we have successfully generated engineered T-cells that can destroy glioblastoma tumor cells in animals in the presence of glucocorticoids. Treatment of recurrent GBM with modified CTLs, an otherwise promising approach for this cancer, is rendered ineffective by the use of glucocorticoids to control inflammation of the brain due to the tumor and surgery. The ZFN-modification of the glucocorticoid receptor (GR) in our engineered CTLs protects the cells from the effects of steroids, which would normally inhibit T-cell function, but does not alter their cytolytic or tumor-killing properties.”