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



2013-01-28 08:34:43 -


· 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®) - 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 for more information.

For further information, please contact:
Tomas Leanderson
President & CEO
Tel +46 46 19 20 95
Email: 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 :
hugin.info/1002/R/1673441/544796.pdf



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Source: Active Biotech via Thomson Reuters ONE
[HUG#1673441]


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