|
ERYtech inclusion last patient Phase II |
ERYtech Pharma, a French biotechnology company, announces the inclusion of its last patient in its Phase II clinical trial for relapsed Acute Lymphoblastic Leukaemia (ALL).
The main goal of this trial is to evaluate the pharmacokinetic, the pharmacodynamic and the safety of GRASPA®, ERYtech Pharma’s new medicinal product. Twenty four patients, comprised of nine adults and nine children received at least one dose of. GRASPA® three other child, and three adult patients received the control product, the free form of native E. coli L-Asparaginase.
Professor Yves Bertrand, Administrator of the Paediatric Institute for Oncology and Haematology in Lyon (IHOP), Chairman of the Child Leukaemia Group of the European Organisation for Research and Treatment of Cancer (EORTC), and Principal Investigator announced: «This trial, which has grouped together many of my Belgian and French confreres and has demonstrated their keen interest in providing a new L-asparaginase with better tolerance and efficacy in ALL treatment. We eagerly await the final results from this trial and remain motivated for the next steps of GRASPA®’s clinical development program»
David Liens, Chief Medical Officer at ERYtech Pharma stated that «the first results will be known in three months time. A development strategy for patients with intolerance to other forms of asparaginases will be rapidly initiated ».
Yann Godfrin, ERYtech Pharma’s Chief Executive Officer would like to extend his thanks to all trial investigators for their motivation and implication, he also acknowledges Dr Irène Philip, Director of the Cellular Therapy Unit at the Léon Bérard Centre (Lyon) for their collaboration and preparation of clinical trial batches. He added, «this Multi-centre Belgian/French trial also allowed us to validate the GRASPA® logistics. This major step for ERYtech Pharma offers smart perspectives».
About GRASPA® (click here for video)
GRASPA® is a new enzyme formulation of L-asparaginase with a safer and broader range of clinical use’s compared to existing forms due to the enzymes entrapment and protection inside the homologous red blood cell.
GRASPA®’s (encapsulating L-asparaginase in red blood cells) interest is to overcome all existing
limitations associated with conventional L-asparaginase through a longer efficacy, better compliance,
reduced dosage and an increased safety profile; making it satisfactory for every ALL patient, even
high risk ones (hypersensitive, elderly patients), or patients with neutralising antibodies.
L-asparaginase is a critical and irreplaceable component of combination chemotherapy for ALL and
has been used in the clinic for over 30 years. The enzyme depletes the plasmatic amino acid
asparagine, which leukaemia cells require to continue their rapid, malignant growth. While normal cells
are able to make a sufficient amount of asparagine internally, leukaemia cells cannot. Infusion of L-
asparaginase destroys the external source of asparagine, which starves leukaemia cells of this amino
acid and leads to cellular death.
Despite its great anti-tumour efficacy, and its availability in different forms, clinicians still remain
unsatisfied by its high toxicity profile (allergic reactions, and toxicity by direct contact with organs).
L-asparaginase inefficiency in many cases is due to the appearance of neutralising antibodies that
arise through repeated enzyme exposure
About GRASPALL
GRASPALL is a comparative, randomized, multi-centre phase II clinical trial in children and adults in first ALL relapse. The main objective of this trial was to determine the relationship between the dose of GRASPA® and the length of plasmatic asparagine depletion. The experimental design followed the therapeutic regimen recommended by EORTC (COOPRALL) with the randomization of the patients amongst 3 doses of GRASPA® (50 IU/kg, 100 IU/kg or 150 IU/kg) or Kidrolase® (control group).
Secondary objectives were to evaluate GRASPA® tolerance, pharmacologic parameters and immunogenicity. Twenty-four patients (12 children and 12 adults) in France and Belgium were enrolled.
About ERYtech Pharma (Click here for more information)
ERYtech Pharma is a leading biotechnology company developing next generation medicinal products
making a huge positive impact on the lives of patients with serious unmet clinical needs.
A pioneer in the encapsulation of therapeutic molecules inside red blood cells, it is developing a
pipeline of innovative therapeutics in orphan indications or underserved subpopulation of high risk
patient’s through its proprietary technology of entrapment and in-depth exploration of red cell
physiologic properties.
ERYtech is focused in the fields of Haematology, Oncology and Metabolic Diseases. ERYtech
Pharma’s most advanced product, GRASPA®, has completed a Phase II clinical trial in leukaemia and
is currently being evaluated in the indication of several solid tumours. Beyond GRASPA®, ERYtech
has several investigational compounds addressing specific unmet clinical needs through enhanced
efficacy, better compliance, reduced dosage or increased safety profile.
|
