Advancell Announces Positive Phase I/IIa Results With Acadra (Acadesine) in Chronic Lymphocytic Leukemia - CLLBy Advancell, PRNE
Sunday, February 20, 2011
BARCELONA, Spain, February 21, 2011 - ADVANCELL (www.advancell.net/), an emerging
biopharmaceutical company, today announced positive results from a clinical
study conducted with Acadra (Acadesine) in Chronic Lymphocytic Leukemia
(www.cancer.gov/) (CLL) patients resistant to current therapies. The
company also announced promising non-clinical results in Multiple Myeloma
(MM), Mantle Cell Lymphoma (MCL) and other lymphoproliferative disorders.
Synergism of Acadra in combination with current treatment in these
indications has been demonstrated.
"We are very pleased with these strong results that make
Acadra a promising first-in-class candidate for further development in CLL
and other indications," said Dr. Kenneth Weissmahr, CEO of Advancell.
"The efficacy observed with Acadra is of particular interest
because there is a clear unmet clinical need in patients who become resistant
to standard therapies and particularly in those who have alterations in the
p53 gene," said Dr. Clara Campas, who is responsible for the clinical
development programs and co-author of the Acadra patent.
Dr. Campas added, "The drug has important synergic effects
with other chemotherapy agents including bortezomib in multiple myeloma and
anti-CD20 monoclonal antibodies in mantle cell lymphoma. The advantage of
Acadra and anti-CD20 antibodies as combination agents is that both are B-cell
directed and independent of p53."
The results of the Phase I/II study (
clinicaltrials.gov/) demonstrated that Acadra (Acadesine) has an
acceptable safety and tolerability profile in doses which induce reduction in
the leukemic tumor burden. The study patient population included 24 patients
with relapsed or refractory CLL who had received a minimum of one prior line
of treatment including either a fludarabine or an alkylator-based regimen.
Seven out of the nine patients treated with Acadra at the
Optimal Biological Dose presented a decrease in absolute B cell count, a
reduction of clinically palpable lymphadenopathies or both. Two patients
presented with symptomatic CLL-related neuropathic pain and skin infiltration
that resolved after Acadra treatment.
Reversible asymptomatic hyperuricaemia was observed in some
patients in part I and was significantly reduced in incidence with the
introduction of mandatory prophylactic allopurinol in subsequent cohorts.
Importantly, Acadra did not induce myelosuppression at any of the doses
tested. No Grade 3 or 4 adverse events occurred at the OBD or below and no
Grade 5 events occurred in the study.
The study was closely followed by a Data Monitoring Board
formed by four independent CLL international experts which concluded that,
"Although the study was not designed to analyze peripheral blood response and
lymph node response, clear evidence of efficacy has been obtained to move
forward. The good safety profile of Acadra observed makes it an attractive
combination partner with other CLL therapies."
Advancell has also conducted in vivo non-clinical studies in
other lymphoproliferative disorders. These studies showed that Acadra has
anticancer activity in Multiple Myeloma and Mantle Cell Lymphoma at doses
which are safe and well tolerated in humans. Interestingly, the drug has
demonstrated synergic effects in combination with bortezomib in a Multiple
Myeloma animal model and in combination with rituximab in a p53-mutated
Mantle Cell Lymphoma animal model. These results suggest the potential use of
Acadra as part of combination therapy in such indications. Dr. Kenneth
Weissmahr comments,"The very encouraging non-clinical data is showing the
potential of Acadra in Multiple Myeloma and Mantle Cell Lymphoma which
increases substantially the market potential of this drug. These results
validate our business model and now we look forward to partner the program
with a company that guarantees its development to market."
Acadra was in-licensed by Advancell from the University of
Barcelona (www.ub.edu/) and co-developed with Protherics (BTG) until
November 2009, when the Spanish biotech licensed-back its rights from BTG.
About Acadra for the treatment of lymphoproliferative
Acadra (acadesine) is an investigational, intravenous, small
molecule that is transformed to its monophosphate active form (ZMP) once
present within cells. Acadra selectively induces cell death (apoptosis) to
B-cell leukemic cells with a mechanism of action independent of p53 status.
This differentiates Acadra from other drugs currently used in CLL, whose
mechanism of action is highly dependent on p53 status. Acadra eliminates
B-cells without affecting T-cells, thus preserving the patient's immunity.
Acadesine was studied as recently as 2010 by Merck in a Phase
III study for prevention of reperfusion injury in CABG surgery and was safe
and well tolerated when administered by an intravenous infusion in a single
Advancell, founded in 2001, is an innovative Spanish
biopharmaceutical company that addresses patients' unmet medical needs and
well-being by developing value-added products. Headquarters are located in
the Barcelona Science Park (PCB).
Advancell's mission is to build a portfolio of high value
pharmaceutical products based on its enabling nanomedicine technology and
from the in-licensing of promising pre-clinical candidates.
Advancell focuses on indications with a clear unmet medical
need in oncology, dermatology and CNS where our technologies and development
capabilities can add distinctive value. The company has four programs in
clinical development and pursues a series of preclinical opportunities.
Contact: Advancell, C/ Baldiri Reixac, 10-12 08028-Barcelona Tel.: +34-93-403-45-45 Fax: +34-93-403-45-44 e-mail: advancell.@advancell.net
Contact: Advancell, C/ Baldiri Reixac, 10-12, 08028-Barcelona, Tel.: +34-93-403-45-45, Fax: +34-93-403-45-44, e-mail: advancell. at advancell.net
Tags: Advancell, Barcelona, February 21, Spain