2013-09-12 10:02:01 -
Detailed analysis further supports effect of ANYARA in
a biomarker defined subgroup
Lund (Sweden), September 12, 2013. Active Biotech (NASDAQ OMX NORDIC: ACTI)
today announced that a biomarker trend analysis of overall survival (OS) and
Progression Free Survival (PFS) from the ANYARA Phase II/III study in renal cell
cancer will be presented at the scientific conference "European Cancer Congress
2013" (ECCO-ESMO-ESTRO) held in Amsterdam, the Netherlands, September 27 -
Professor Tim Eisen, Department of Oncology, Cambridge University Hospitals NHS
Foundation Trust, UK,
will present "Baseline biomarker trend analysis of a
randomized phase 2/3 study of naptumomab estafenatox plus IFN-alpha vs IFN-alpha
in advanced renal cell carcinoma *".
The detailed analysis gives further support to the previous findings that low
baseline levels of pre-formed antibodies against ANYARA or low levels of the
cytokine IL-6, independently predict anti-tumor efficacy after ANYARA+IFN-alpha
treatment. The results also highlight the potential role of IL-6 as a predictive
factor for the outcome of immunotherapy of cancer in general.
The analysis showed clear trends of increased OS (decreasing Hazard Ratios,
"HR"s) in patients with decreasing IL-6 and anti-ANYARA antibodies. Similar
trends were seen for PFS HRs.
For more detailed information, please see eccamsterdam2013.ecco-
org.eu/. The presentation will be available on Active Biotech's web site
* T. Eisen, G. Hedlund, G. Forsberg, Ö. Nordle, R. Hawkins.
ABOUT THE ANYARA PHASE II/III STUDY
The Phase II/III study encompassed 513 patients from approximately 50 sites in
Europe (UK, Ru, Uk, Bu, Ro) and was designed to evaluate the effect of ANYARA
(naptumomab estafenatox) in combination with interferon-alpha, compared with
interferon-alpha alone, in patients with advanced renal cell cancer. The primary
endpoint was overall survival (OS). Secondary endpoints were Progression Free
Survival (PFS) and safety. The results were presented at ASCO in June 2013. High
baseline levels of pre-formed antibodies against superantigens were shown to
decrease ANYARA levels while the biomarker IL-6 was suggested to be a predictive
marker for immune therapies. Although the study did not achieve its primary
endpoint to show a prolonged OS in the overall ITT population, the addition of
ANYARA to interferon-alpha improves OS and PFS in a biomarker defined subgroup.
In this subgroup, patients with high levels of pre-formed antibodies against
superantigens or the cytokine IL-6 were excluded. In this subgroup of 130
patients, the median OS for the ANYARA vs. placebo treatment arm were 63.3 vs.
31.1 months (HR: 0.59; p=0.020), respectively. The median PFS were 13.7 (ANYARA)
vs. 5.8 (placebo) months (HR: 0.62; p=0.016).
ANYARA is a TTS (Tumor Targeting Superantigen) compound that makes the treatment
of cancer tumor-specific. The development of ANYARA is mainly focused on renal
cell cancer. Positive data was reported from clinical Phase I trials in lung
cancer, renal cell cancer and pancreatic cancer. In July 2009, the results from
two Phase I studies of ANYARA were published in the Journal of Clinical
Oncology, where ANYARA was studied both as a single agent (monotherapy) and in
combination with an established tumor therapy - docetaxel (Taxotere®) - in
patients with advanced cancer. The results showed that ANYARA was well tolerated
both as monotherapy and in combination with docetaxel. ANYARA has been granted
orphan-drug status by the EMA for the indication renal cell carcinoma.
ABOUT RENAL CELL CARCINOMA
Renal Cell Carcinoma (RCC) affects approximately 180,000 people worldwide each
year. Approximately 50 % of the patients are affected by metastases. If the
disease has metastasized, average survival is around 2 years. The survival rate
of patients diagnosed with renal cancer is only 5-15% after five years. The
market for treatment of RCC is estimated at approximately USD 2.7 billion per
year (EvaluatePharma March 2012).
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with
focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase
are laquinimod, an orally administered small molecule with unique
immunomodulatory properties for the treatment of multiple sclerosis, tasquinimod
for prostate cancer and ANYARA primarily for the treatment of renal cell cancer.
In addition, laquinimod is also in Phase II development for Crohn's and Lupus.
The company also has one additional project in clinical development, the orally
administered compound paquinimod (57-57) for systemic sclerosis. Please visit
www.activebiotech.com for more information.
For further information:
Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00
Active Biotech's Safe Harbor Statement in Accordance with the Swedish Securities
This press release contains certain forward-looking statements. Such forward-
looking statements involve known and unknown risks, uncertainties and other
important factors that could cause the actual results, performance or
achievements of the company, or industry results, to differ materially from any
future results, performance or achievement implied by the forward-looking
statements. The company does not undertake any obligation to update or publicly
release any revisions to forward-looking statements to reflect events,
circumstances or changes in expectations after the date of this press release.
Active Biotech is obligated to publish the information contained in this press
release in accordance with the Swedish Securities Market Act. This information
was provided to the media for publication 10:00 am CET on September 12, 2013.
Active Biotech's project ANYARA will be presented at the European Canc:
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Active Biotech via Thomson Reuters ONE