Positive results confirmed in final report for Active Biotech's TTS cancer product
The primary endpoint was defined as the number of responders to treatment. After 2 and 4 months of TTS CD2 treatment, 68% and 40% of the patients showed stable disease (SD), respectively. Median time to progression was 119 days.
Of the total number of renal-cancer patients included in the study, 72% had previously received treatment with Interleukin-2, Interferon-alpha or chemotherapy, but continued to progress. The high frequency of patients with stable disease in the study indicates the efficacy of treatment. Furthermore, the TTS products possess a unique, immune-mediated mode of action with few and mild side effects.
One patient in the study showed a sustained partial response (PR) lasting more than 11 months. This patient received a relatively high dose compared to the main population, a fact that emphasises the need for optimised dosing. This was previously noted in a separate TTS clinical study in patients with non-small cell lung cancer (NSCLC)(2).
"The high number of patients with stable disease clearly indicates that we have an active drug. A very clear response is demonstrated in the patient having received a substantially higher dose, which indicates that it is a matter of being able to give higher TTS doses", says Professor Robert Hawkins, Principal Investigator, Christie Hospital in Manchester, UK.
In parallel, the candidate drug TTS CD3 has been optimised with the objective to possess an enhanced anti-tumour activity with lower general toxicity. This means that it can be given at significantly higher doses, which was shown in the TTS CD2 study to be of crucial importance.
In addition, a reduction of antigenicity in TTS CD3 facilitates the handling of the treatment, since it can be given to patients in a standardised bolus injection rather than in an individualised infusion as TTS CD2. A separate patent application has been submitted by Active Biotech for TTS CD3.
A phase I clinical dose escalation trial with TTS CD3 is ongoing at the Fox Chase Cancer Center in Philadelphia, USA and at the Radiumhospitalet in Oslo, Norway, in patients with non-small cell lung cancer (NSCLC)(3). At present, a dose approximately 10 times higher than the dose of TTS CD2 previously given has successfully been administrated to patients.
Having reached the objectives for TTS CD2 and CD3 development, Active Biotech has decided to focus future TTS development on TTS CD3. The TTS CD3 development will primarily be directed towards approval for the treatment of NSCLC. Today, NSCLC is primarily treated with chemotherapy and surgery. There is an extensive medical need for new treatment methods, since available therapies do not provide satisfactory results and have major side effects.
The timing of the ongoing Phase I study will be decisive for the start of controlled Phase II/III trials but current estimates for the initiation of such trials would be during2005.
"The decision to focus on CD3 is purely commercial. The CD2 development has provided a solid base and vital data on the biological activity of the TTS compounds. The focus on CD3 will lead to a more efficient development program with an attractive product profile. Overall development cost will be reduced and we expect a prolonged patent life up to year 2021", says Sven Andréasson, President & CEO of Active Biotech.
Non small-cell lung cancer (NSCLC) is one of the most commonly occurring malignant diseases. It is also the form of cancer with the highest mortality rate. NSCLC affects close to a million people worldwide each year. There are no sufficiently effective treatment methods. The market for drugs used in the treatment of lung cancer are currently valued at slightly more than
USD 1 billion (Source: Blomquist & Associates, February 1, 2003).
Lund, December 17, 2003
Active Biotech AB (publ)
President & CEO
Active Biotech AB is a biotechnology company focusing on research in and development of pharmaceuticals. Active Biotech has a strong R&D portfolio and pipeline products with focus primarily on autoimmune/ inflammatory diseases and cancer. Most advanced projects include orally administered small molecules with unique immunomodulatory properties that can be used to treat autoimmune and inflammatory diseases (SAIK-MS), as well as a novel concept for use in cancer immunotherapy (TTS).
Active Biotech AB
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