Advancell Announces Positive Phase I/IIa Results With Acadra (Acadesine) in Chronic Lymphocytic Leukemia – CLL

February 21, 2011

BARCELONA, Spain, February 21, 2011 /PRNewswire/ — ADVANCELL
(http://www.advancell.net/), an emerging biopharmaceutical company, today
announced positive results from a clinical study conducted with Acadra
(Acadesine) in Chronic Lymphocytic Leukemia (http://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 ( http://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
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
(http://www.ub.edu/) and co-developed with Protherics (BTG) until November
, when the Spanish biotech licensed-back its rights from BTG.

About Acadra for the treatment of lymphoproliferative disorders

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 dose.

About Advancell

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.


    Advancell, C/ Baldiri Reixac, 10-12
    Tel.: +34-93-403-45-45
    Fax: +34-93-403-45-44
    e-mail: advancell.@advancell.net

    web: http://www.advancell.net/

SOURCE Advancell

Source: newswire

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