Targovax AS Announces First Patient Included In Phase I/II Clinical Study With The Therapeutic Cancer Vaccine TG01 In Operable Pancreatic Cancer
Approval from the Norwegian Medicines Agency (NOMA) to start clinical phase I/II study in Norway was received in November, and first patient was recruited in January.
18-24 patients will be included in the clinical Phase I/II study. Results from the Phase I part are expected in first half of 2013.
Principal investigator and oncologist Svein Dueland states: “It is exciting that we now recruit patients for this study, which originates from collaboration between Oslo University Hospital and Norsk Hydro. Participation in clinical trials is an important part of the treatment we can offer cancer patients.”
Hanne Mette D Kristensen, CEO, says: “We are proud that Targovax now has its first drug in clinical Phase I/II, only two years after the company’s inception. The study will run at the Radium Hospital at Oslo University Hospital, international pioneers in development of immunotherapy and cancer vaccines. TG01 has already shown promising results in patients. If these results are confirmed by systematic studies, TG01 may mean the first real change for pancreatic cancer patients.”
Targovax is owned by The Radium Hospital Research Foundation, Birk Venture and RO Invest, inventors and management. The company has received grant from Innovation Norway for running the clinical Phase I/II trial in collaboration with OUS, The Radium Hospital.
Targovax is a cancer biotech-company started in October 2010. The TG01 cancer vaccine is therapeutic; it is given as treatment to patients who already have cancer to prevent recurrence, and educates the body’s immune system to recognize and kill cancer cells.
Approximately 80-90% of pancreatic cancers have RAS mutations. Cancers with RAS mutations have proved to be difficult to treat with current treatment, and there is a significant unmet medical need.
A follow-up review of clinical trials from the end of the 90′es indicates increased survival for patients treated with TG01. Some of these patients are still alive more than ten years later. This is promising within a disease with very poor prognosis.
TG01 has received Orphan Drug Status for pancreatic cancer in EU and USA. Targovax owns patents and the documentation from earlier development of TG01.
Source: Targovax AS