An adjuvant approach to Cancer therapy:
Innovation through simplification ...
Advantagene: Making the “Standard of Care” for cancer work better
Advantagene’s therapeutic approach is called Gene Mediated Cytotoxic Immunotherapy (GMCI™). GMCI™ is a local immunotherapy that fights systemic micrometastases. This “off-the-shelf immunotherapy” is based on an adenoviral vector that encodes the gene for the Herpes Simplex Virus thymidine kinase (AdV-tk). The vector is injected directly at the site of disease, after which the patient receives a two-week course of a prodrug. GMCI™ can even be administered in an outpatient setting, if permitted by the underlying standard of care.
Since GMCI™ works via a novel mechanism, and is synergistic with standard care--radiation, surgery, and many chemotherapies--no aspect of existing care needs to be replaced. Our approach improves patient outcomes without interrupting proven therapies. Integration with the standard of care procedures allows very efficient, non-disruptive clinical studies, helping to manage the cost of clinical development, and driving adoption by patients and physicians. Furthermore, after more than 300 patient doses, the safety profile of GMCI™ is excellent. These product attributes insure the continuation of rapid clinical adoption through product commercialization.
Advantagene’s two lead products are in advanced stages of clinical development. ProstAtak™, for prostate cancer, has completed a Phase II study with positive results and received Fast-Track designation from the FDA. GliAtak™, a malignant glioma product, has completed a Phase I dose finding study with highly encouraging results, received funding from the National Institutes of Health for further development and has received Orphan Drug designation from the FDA. A follow-on Phase Ib/randomized Phase II study is in progress. In addition the company has a Phase I study open for its pancreatic cancer product, PancAtak™.
Advantagene also has a full pipeline of preclinical products that target major cancers at the initial removal of primary tumors to prevent local and metastatic recurrence. Advantagene holds three primary U.S. patents (1997-2001) and one European (2004) issued patent providing FTO and exclusivity. Advantagene also has exclusive worldwide rights to intellectual property related to this novel cancer immunotherapy.
Since GMCI™ works via a novel mechanism, and is synergistic with standard care--radiation, surgery, and many chemotherapies--no aspect of existing care needs to be replaced. Our approach improves patient outcomes without interrupting proven therapies. Integration with the standard of care procedures allows very efficient, non-disruptive clinical studies, helping to manage the cost of clinical development, and driving adoption by patients and physicians. Furthermore, after more than 300 patient doses, the safety profile of GMCI™ is excellent. These product attributes insure the continuation of rapid clinical adoption through product commercialization.
Advantagene’s two lead products are in advanced stages of clinical development. ProstAtak™, for prostate cancer, has completed a Phase II study with positive results and received Fast-Track designation from the FDA. GliAtak™, a malignant glioma product, has completed a Phase I dose finding study with highly encouraging results, received funding from the National Institutes of Health for further development and has received Orphan Drug designation from the FDA. A follow-on Phase Ib/randomized Phase II study is in progress. In addition the company has a Phase I study open for its pancreatic cancer product, PancAtak™.
Advantagene also has a full pipeline of preclinical products that target major cancers at the initial removal of primary tumors to prevent local and metastatic recurrence. Advantagene holds three primary U.S. patents (1997-2001) and one European (2004) issued patent providing FTO and exclusivity. Advantagene also has exclusive worldwide rights to intellectual property related to this novel cancer immunotherapy.
The promise of cancer immunotherapy is in the prevention and control of recurrent disease. While traditional approaches to the management of cancer, including surgery, chemotherapy, and radiation therapy have been proven to improve patient outcomes, these approaches generally leave behind small amounts of disease, resulting in the inevitable return of a more aggressive cancer—with fewer treatment options.
