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

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 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 (http://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 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.

    
    Contact:

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

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