Santaris Pharma presents positive clinical data on SPC2996 in Chronic Lymphocytic Leukaemia

First RNA Antagonist medicine to be tested in patients reduces severity of adult leukaemia

COPENHAGEN, Denmark | June 6, 2007 |
Santaris Pharma, the Danish biopharmaceutical company, announced today that SPC2996, the Company’s new RNA Antagonist of Bcl-2, has shown early evidence of efficacy in an initial Phase I/II clinical study in Chronic Lymphocytic Leukaemia (CLL). The results of the study were reported this week at the 2007 Annual Meeting of the American Society of Clinical Oncology, held in Chicago, Illinois.

The clinical trial was conducted in patients with advanced CLL, the most common form of adult leukaemia, and involved 12 centres in France, Britain, Denmark, and the USA. Conclusions from the study were as follows:

-- A reduction in the number of cancerous B-lymphocytes (white blood cells) and a beneficial effect on lymph nodes and overall tumour response was observed in patients given 6 repeated doses of drug at 4mg/kg/infusion over a two week period, with the effects on lymphocytes being seen within 24 hours of the first dose.

-- A relationship between dose of SPC2996 and activity was observed in the study, with higher doses giving improved effects on lymphocyte counts, lymph nodes, time to progression and overall tumour response.

-- SPC2996 treatment was associated with statistically significant reduction in mean Bcl-2 levels in white blood cells from CLL patients, supporting the intended mechanism of action of the drug.

Commenting on the results, Prof Bertrand Coiffier, from the Hospices Civils de Lyon, University of Lyon, France, the international coordinating investigator for the study, said:

“These results are early stage but promising. All patients came into this study with clinically progressing CLL. Despite this, patients receiving the drug at an effective level had rapid and sustained falls in circulating cancerous lymphocytes. There also appeared to be evidence of drug induced tumour responses. We look forward to further studies with this interesting new agent in CLL.”

The Phase I/II study was primarily aimed at finding the optimum dose of drug to be given in longer term, more rigorously controlled trials in CLL and Lymphoma, a related and more common tumour type. Dr Lene Worsaae Dalby, Santaris Pharma’s Vice-President of Clinical Development, said:

“We are encouraged by the data from this safety and proof of principle study. We are currently conducting a second trial with SPC2996 to optimise dose scheduling in favour of fewer doses of the drug given at higher concentrations. Following this second Phase I/II study, Santaris expects to commence randomised Phase II studies in CLL and to investigate the drug also in follicular lymphoma”.

The trial of SPC2996 in CLL is the first time an RNA targeted antisense drug containing the potent RNA analogue, Locked Nucleic Acid (LNA), has been evaluated in man for safety and efficacy. SPC2996 was well tolerated and infusions were unproblematic. Dr Henrik Orum, Santaris Pharma’s Chief Scientific Officer, commented:

“This clinical trial confirms that LNA-based drugs can be given safely to patients, can reach the site of action in cancer cells and are potent enough to induce clinically relevant benefits, even when given for only a brief period. This is encouraging for the rapidly advancing new field of RNA targeted medicines and for the future of RNA Antagonists in particular. We look forward to further human studies with this and other LNA-based drugs.”

SOURCE: Santaris Pharma

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