Print“An analysis of 30 patients in that trial found the drug to be ineffective. The company says it is also shutting down a mid-stage study in patients with non-small cell lung cancer because it could not enroll enough patients.”
Geron will quit development of the experimental brain cancer therapy, GRN1005, and cut 43 related jobs as it shifts its focus to testing another drug candidate, imetelstat, as a treatment for blood cancers and some types of solid tumors. It was the second clinical program cut by the company in 2012. The company scrapped plans to pursue imetelstat for the treatment of metastatic HER2-negative breast cancer after worries arose about the drug’s safety and efficacy in a mid-stage trial.
“We are very disappointed that the results of the GRN1005 program fell short of our criteria for further development,” says John Scarlett, Geron's president and CEO.
Geron says the decision to discontinue development of GRN1005 was made after the company completed a planned interim analysis for its mid-stage study in patients with metastases arising from breast cancer. An analysis of 30 patients in that trial found the drug to be ineffective. The company says it is also shutting down a mid-stage study in patients with non-small cell lung cancer because it could not enroll enough patients.
The lack of available therapies for brain metastases, and the unique approach of GRN1005 class of therapeutics made this therapy an attractive one to pursue. The drug takes advantage of receptors highly expressed at the blood-brain-barrier, the major physical obstacle to the delivery of therapeutic molecules into the central nervous system. The receptors of interest belong to the low-density lipoprotein cholesterol-binding receptor family and help provide brain cells with nutrients.
Geron’s drug, GRN1005, developed by Angiochem as ANG1005, binds to one of these receptors known as the LDL receptor–related protein. By taking advantage of a process by which molecules are absorbed through cell membranes, the drug in essence can get a ride through the blood-brain-barrier into the brain where it can have an effect.
But studies of GRN1005 have shown mixed results. One positive study of the drug in animal brain tumor models showed tumors were undetectable in 63 percent of eight treated animals. Results from the first-in-human study for advanced solid tumors, however, showed a partial response in only five of the 20 patients receiving the maximum tolerated dose; but in those five patients shrinkage of brain lesions was observed.
Cancellation of the GRN1005 program spells trouble for Angiochem’s small molecule cancer program. Geron has already told Angiochem it is terminating its licensing of GRN1005 as well as an associated research collaboration and option agreement.
The value of Geron’s shares briefly dipped below $1.00 in heavy trading following the announcement before stabilizing at about $1.14 per share.
December 07, 2012
http://www.burrillreport.com/article-geron_favors_telomerase_target_over_blood_brain_barrier_in_company_restructuring.html
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