Cell Genesys Reports Clinical Scale Production Capabilities for Lentiviral Gene Therapy
BOSTON, June 11 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) today announced that company scientists have developed a proprietary lentiviral-producing cell line that will enable the production of large quantities of high quality lentiviral gene delivery vector. This new technology is expected to enable Cell Genesys to produce sufficient quantities of high quality vector for future human clinical trials, an objective not readily achieved with earlier generation production methods for lentiviral vectors. The new production technology provides both scaleable and stable production capabilities. Lentiviral vectors are highly efficient at delivering genes to multiple types of dividing and non-dividing cells, including nerve, liver, muscle and bone marrow stem cells, making them potentially applicable to the gene therapy of a wide range of serious diseases. These data were presented at the American Society of Gene Therapy (ASGT) Meeting in Boston, MA by Deborah Farson, associate director in the molecular virology department of Cell Genesys.
Lentiviral vectors are gene delivery vehicles that have demonstrated efficient and long lasting in vivo gene transfer into a variety of cell types. In comparison to other viral vectors, lentiviral vectors have a large gene delivery capacity and can therefore be used to deliver a wider range of therapeutic genes. Scientists at Cell Genesys have enhanced the safety profile of the lentiviral vector, which is derived from the human immunodeficiency virus (HIV), by eliminating six genes, five of which are associated with replication (virulence), without reducing the efficiency of gene delivery. The removal of these six genes is accompanied by the addition of a built-in self-inactivating safety feature that further decreases the potential for the vector to replicate or recombine with wild-type virus during vector manufacturing or patient treatment.
"Lentiviral vectors are one of the most efficient gene delivery vehicles for gene therapy, and we are pleased to advance this vector to a position where we may be able to evaluate its benefit in the human clinical trial setting," stated Peter K. Working, Ph.D., vice president, research and development. "While we intend to further evaluate the potential applicability of this technology to the development of novel cancer treatments which is our business focus, we also plan to enter into external collaborations to evaluate lentiviral gene therapy for other serious diseases."
Lentiviral vectors, given their demonstrated success in preclinical studies of delivering genes to multiple cell types, may have broad utility in the treatment of multiple diseases including genetic deficiency disorders such as hemophilia A, a blood clotting disorder. The initial clinical target is likely to be a life threatening genetic deficiency disorder through a sponsored research collaboration at an academic center, and discussions to this effect are now under way. Additionally, Cell Genesys' lentiviral vectors have been made available to the company's majority-owned subsidiary, Ceregene, Inc., for use in gene therapies for neurologic disorders.
Cell Genesys has four different gene delivery technologies with potential applications in both in vivo and ex vivo gene therapy. These vector systems include adeno-associated viral (AAV) vectors, lentiviral vectors, adenoviral vectors and retroviral vectors. Viral-based gene delivery systems have generally been found to be more efficient in delivering therapeutic genes than non-viral vectors. To date, Cell Genesys has engineered multiple proprietary viral vectors to deliver different therapeutic genes associated with different disease indications. Cell Genesys' principal goal in its gene therapy program is to deliver genes safely and efficiently in order to achieve long term gene expression and thus potentially provide a more lasting therapeutic benefit to patients.
Cell Genesys is focused on the development and commercialization of innovative therapeutic products for cancer based on gene therapy technologies. The company is pursuing three cancer product platforms -- GVAX® cancer vaccines, oncolytic virus therapies and in vivo cancer gene therapies. Clinical trials of GVAX® vaccines are under way in lung cancer, prostate cancer, pancreatic cancer, leukemia and myeloma. Clinical trials of oncolytic virus therapies include CG7060 and CG7870 in prostate cancer. Preclinical stage programs include oncolytic virus therapies and gene therapies for multiple types of cancer. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold approximately nine million shares of common stock in its former subsidiary, Abgenix, an antibody products company. Cell Genesys is headquartered in Foster City, CA and has manufacturing operations in San Diego, CA, Hayward, CA and Memphis, TN. For additional information, please visit the company's website at www.cellgenesys.com.
Statements made herein, other than statements of historical fact, including statements about the company's and its subsidiaries' progress, results of clinical trials and preclinical programs, marketability and success of potential products, projected product development timelines and nature and growth of product pipelines are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the continuation of research collaborations, the success of research and development programs, results achieved in future preclinical studies and clinical trials, the regulatory approval process, competitive technologies and products, the scope and validity of patents, corporate partnerships and additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K dated April 1, 2002 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission.
CONTACT: Jennifer Cook Williams, Associate Director, Corporate Communications of Cell Genesys, Inc., +1-650-425-4542.
SOURCE: Cell Genesys, Inc. |
