Key Developments For Geron Corp
Geron Corp (GERN.O) (Consolidated Issue listed on NASDAQ Global Market)
Geron Corporation Collaborators Publish Data On hESC-Derived Glial Progenitor Cell Therapy In Cervical Spinal Cord Injury
Geron Corporation announced the publication of data showing that oligodendrocyte progenitor cells (OPCs) derived from human embryonic stem cells (hESCs), when transplanted into a rodent model of cervical spinal cord injury, reduced tissue damage within the lesion and improved recovery of locomotor function. These data provide preclinical proof-of-concept for the use of GRNOPC1, Geron's hESC-derived oligodendrocyte progenitor product, in patients with cervical spinal cord injuries. Over half of the 11,000 human spinal cord injuries that are sustained in U.S. annually are in the cervical region. The cervical injury model used in this study induced widespread tissue loss resulting in a cavity in the spinal cord. In contrast, there was no cavity in the spinal cord of the rodents that had been injected with hESC-derived OPCs seven days after injury, and the transplant area contained human oligodendrocytes. Further analysis of the injury sites revealed there were significantly more normally myelinated neurons, fewer demyelinated neurons, and importantly, a greater number of preserved motor neurons compared to controls. These data provide in vivo evidence that hESC-derived OPCs may protect the spinal cord from tissue damage induced by injury in addition to having a remyelinating function. Along with these observations was noted a decrease in genes associated with tissue damage and inflammation suggestive of a mechanism in which hESC-OPCs are exerting their tissue-sparing effect.
Geron Corporation and FDA Reach Agreement on Clinical Hold
Geron Corporation announced the Company`s plan to advance clinical development of its human embryonic stem cell (hESC)-based product, GRNOPC1, for the treatment of spinal cord injury. The plan is expected to enable Geron to re-initiate the Phase I clinical trial of GRNOPC1 in patients with complete thoracic spinal cord injury and to support future expansion of the trial to patients with cervical injuries. As part of ongoing work to optimize GRNOPC1 manufacturing and product release, the Company developed new candidate markers and assays. Data from studies using the new markers were submitted to the FDA. The IND for spinal cord injury was placed on clinical hold pending FDA review of the data. Geron will complete a confirmatory preclinical study using GRNOPC1 that has been characterized by the new markers and assays, as agreed upon in discussions with the FDA. As part of the ongoing plan to advance clinical development to cervical patients, Geron had already initiated this preclinical study in an animal model of cervical injury. In discussions with the Company, the FDA has advised that it concurs with Geron that positive data from this study can be used to support both release of the clinical hold and expansion to cervical patients. Geron expects the data from this study to enable re-initiation of the clinical trial in the third quarter of 2010.
Corning Incorporated And Geron Corporation Showcase New Synthetic Surface Matrices To Enhance Stem Cell Growth
Corning Incorporated and Geron Corporation announced the development of novel synthetic surface matrices demonstrated to enhance and support the scalable manufacturing and growth of human embryonic stem cells (hESCs). Through its ongoing collaboration with Geron, Corning has developed a synthetic surface that supports the growth and differentiation of hESCs in a defined (animal-free) medium. Data presented today at the World Stem Cell Summit in Baltimore, Md., will show multi-passage growth of multiple undifferentiated hESC lines and the subsequent differentiation of one of these cell lines into cardiomyocytes. Laboratory products using specialized surfaces resulting from this collaboration will be commercialized by Corning subject to certain commercial use restrictions. Geron will receive a royalty on future product sales and has exclusive rights to use the surfaces in the manufacturing of certain therapeutic products. Through this collaboration, a platform of surfaces is in development to support the needs of stem cell researchers worldwide in their efforts to grow specific cells in quantities desired for research purposes.
Geron Corporation Announces Direct Equity Issuance
Geron Corporation announced that it has sold shares of the Company common stock and issued warrants to purchase common stock to institutional investors for proceeds of $3.6 million. The proceeds will fund an equity contribution to ViaGen, Inc., in which the Company holds a 27% ownership interest. The Company sold 550,000 shares of common stock and issued warrants to purchase additional shares at a premium. Both the common stock sold and the stock underlying the warrants are subject to a lock-up on sale from the date of issuance. The shares and warrants were offered through a prospectus supplement to the Company's effective universal shelf registration statement. The Company arranged the financing directly with the investors.
Geron Corporation's Investigational New Drug Application For Spinal Cord Injury Placed On Hold
Geron Corporation announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency`s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial. Geron Corporation will work closely with the FDA to facilitate their review of the new data and to release the clinical hold. No patients have yet been treated in this study.
