Results from Active Biotech's Phase II/III ANYARA trial for the treatment of renal cell cancer

Mon Jan 28, 2013 2:31am EST

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· The primary endpoint - to show a survival advantage in the intention to treat (ITT) population -
was not reached.
· In a subgroup analysis, patients with low/normal baseline IL-6 and expected anti-superantigen
antibody levels demonstrated proof of concept with ANYARA treatment comprising both a
significantly prolonged overall survival (OS; p=0.02, HR=0.59) and Progression Free Survival
(PFS).


Lund, Sweden, January 28, 2013 - Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today the
initial results from the ANYARA Phase II/III clinical study. The study encompassed 513 patients
and was designed to evaluate the effect of ANYARA in combination with interferon-alpha, compared
with interferon-alpha alone, in patients with advanced renal cell cancer. The primary endpoint was
overall survival (OS).

The results showed that the ANYARA Phase II/III study did not achieve its primary endpoint to show
a prolonged OS in the ITT population. Unexpectedly, and in contrast to previous studies in other
territories, a majority of the patients in the current study had high levels of pre-formed
antibodies against the superantigen component of ANYARA. A subgroup analysis, excluding patients
with high levels of pre-formed antibodies, resulted in a trend for survival benefit with ANYARA
treatment. Furthermore, baseline levels of the biomarker IL-6 was shown to be an important
predictive marker for a positive treatment effect of ANYARA.

In a hypothesis generating subgroup analysis, the 25 % of patients with low/normal levels of base
line IL-6 and expected anti-superantigen antibody levels, showed a statistically significant
treatment advantage on both OS (p=0.02, HR=0.59) and PFS. In North America and Western Europe,
this subgroup account for 40-50% of the total number of advanced renal cell cancer patients. 
 
"The presence of pre-formed antibodies in a high number of patients was unexpected and we are
disappointed that the primary endpoint of this trial was not reached. However, there is a
treatment effect in a significant subgroup of patients, and this observation is congruent with
ANYARAs mode of action" said Tomas Leanderson, President & CEO Active Biotech. "Based on these
data, we will seek a partner for the continued development of this unique, targeted, immune
therapy".

The safety profile was good and in line with previous observations; the most common adverse events
associated with ANYARA treatment were grade 1-2 fever, nausea or vomiting. No new and unexpected
safety concerns were identified in the study.

Additional analyses of the ANYARA Phase II/III study data are ongoing, and results will be
submitted for presentation at a scientific congress later in the year. The company will also
discuss future development strategies with major regulatory authorities.

 
ABOUT THE ANYARA PHASE II/III STUDY
The Phase II/III study was designed to evaluate the effect of ANYARA in combination with
interferon-alpha, compared with interferon-alpha alone, in patients with advanced renal cell
cancer. The primary endpoint was overall survival (OS). In May 2008, a positive interim analysis
of safety and efficacy was performed and the study continued into the Phase III part. Enrollment
of 513 patients was completed in June 2009 and recruited patients from approximately 50 sites in
Europe (UK, Ru, Uk, Bu, Ro). Secondary endpoints in the study were Progression Free Survival (PFS)
and safety.

ABOUT ANYARA
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(R)) - 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. Half of
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). Approved first line treatments are Sutent, Avastin + IFN, Torisel and
Votrient. Approved for second line treatment are Nexavar and Everolimus.

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, TASQ for prostate cancer and ANYARA primarily for the treatment of renal cell cancer.
In addition, laquinimod is in Phase II development for Crohn's and Lupus. The company also has one
additional project in clinical development, the orally administered compound 57-57 for Systemic
Sclerosis. Please visit www.activebiotech.com http://www.activebiotech.com  for more information.

For further information, please contact:
Tomas Leanderson
President & CEO
Tel +46 46 19 20 95
Email: tomas.leanderson@activebiotech.com mailto:tomas.leanderson@activebiotech.com 


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 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 8:30 a.m. CET on January 28, 2013.

Results from Active Biotech's Phase II/III ANYARA trial 
http://hugin.info/1002/R/1673441/544796.pdf 


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