Advancell Announces Positive Phase I/IIa Results With Acadra (Acadesine) in CLL

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BlankAdvancell Announces Positive Phase I/IIa Results With Acadra (Acadesine) in

Chronic Lymphocytic Leukemia - CLL

Press Release

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. 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. 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.