Positive results reported by Active Biotech's TTS Phase I cancer study
The studies were performed on patients with non-small-cell lung cancer (NSCLC), one of the most common tumor forms that also has by far the highest mortality rate. Almost half a million people develop NSCLC every year, and there are no effective treatment. NSCLC is primarily treated with chemotherapy and surgery.
The primary goal of a Phase I clinical trial is to determine effective and safe doses of the product in question, but since this study was performed on cancer patients, the product's therapeutic effect on the tumor itself was also studied. TTS is a unique form of cancer treatment in which an antibody combined with a toxin stimulates the immune system to specifically attack the tumor cells.
A total of 66 patients were evaluated in the study. One month after treatment, 46% of these patients had a stabilization of the disease, which means that the tumor load had not increased. For half of these patients, the course of the disease remained unchanged after two months of observation. In some patients, the tumor stabilization lasted 6 months or more without repeating the treatment. Such long-term stabilization of the disease is noteworthy, since the patients involved in the study had a very poor prognosis and were not expected to improve after any of the currently available forms of treatment. More than two thirds of the patients had undergone at least one course of chemotherapy to which they no longer responded.
Another strong indication of the product's clinical effect is the fact that the tumor mass of seven patients was reduced by more than 25 per cent, a reduction that lasted for at least four weeks in five cases. The maximum tumor reduction observed was 48 per cent.
"This agent was exceedingly well tolerated. In this highly selected group of patients, durable freedom from disease progression was observed in several individuals who had manifested progressive disease at the time of enrolment. Also the observed median survival is promising", says Dr. Corey Langer, Principal Investigator, Fox Chase Cancer Center, Philadelphia, who treated many of the patients.
The Phase I study was designed as a dose escalation study in which patients received repeated doses of the TTS product. The principal aim of the study was to define the maximum tolerable dose that can be safely administered to patients, although all tumor effects were also documented. The most common side-effect seen in the study was a short-lived drop in blood pressure, which was expected. This means that the product's safety has now been documented.
"The fact that the side-effects are easy to manage, together with the anti-tumor effect observed in the study, has left us even more convinced of the potential of the TTS concept," says Tomas Leanderson, Head of R&D at Active Biotech.
The clinical Phase II trial will commence in the autumn of 2001 in collaboration with the Karolinska Hospital in Stockholm and Christie Hospital in Manchester.
Lund 26 June 2001
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Active Biotech is a biotechnology company focusing on research in and development of pharmaceuticals and vaccines. Our expertise lies in our in-depth knowledge of the human immune system. We have a high-quality project portfolio with significant value potential. Important products and projects include drugs for use in treating multiple sclerosis (SAIK) and cancer (TTS), as well as the cholera vaccine, SBL Cholera Vaccine and the tourist diarrhoea vaccines, Dukoral and ETEC. Active Biotech's net sales in 2000 totalled SEK 280 million.
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