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Ablynx [Euronext Brussels: ABLX] today announced that it has initiated a Phase I clinical trial in healthy volunteers with ALX-0651, an anti-CXCR4 Nanobody, for use in stem cell mobilisation. ALX-0651 is the first Nanobody in clinical trials targeting a GPCR, a target class that has proven to be difficult to address with conventional antibodies. It is the second Nanobody that has entered clinical development this year, which brings the total number of Nanobodies in the clinic to seven.
CXCR4 plays a key regulatory role in hematopoietic stem cell trafficking. Blocking CXCR4 effectively releases the hematopoietic stem cells from the bone marrow and allows them to be mobilised to the peripheral blood for collection and subsequent transplantation in patients.
Hematopoietic stem cell transplantation is used to reconstitute the bone marrow and repopulate the blood and immune system in patients whose immune system has been depleted of stem cells as a result of high-dose chemotherapy. It has become a widely used procedure in patients with multiple myeloma and non-Hodgkin's lymphoma.
The Phase I study will evaluate the safety and tolerability of ALX-0651. The study will investigate the PK/PD and immunogenicity profile of the Nanobody and will establish one or more biologically effective dose levels and/or the maximum tolerated dose.
The study is expected to recruit between 70 and 120 healthy volunteers and will include a single-blinded, placebo-controlled single ascending dose phase with six to seven dose levels, followed either by an open-label extension phase or a multiple dose phase.
Dr Edwin Moses, CEO and Chairman of Ablynx, commented: "We are delighted to see our first Nanobody that targets a GPCR progressing into the clinic. GPCRs form part of an important drug target class that is difficult to address with conventional antibodies but the unique characteristics of our Nanobodies have allowed us to generate active lead Nanobody candidates for a number of different GPCRs. We are looking forward to seeing the outcome of this first clinical study during the course of 2012. There are now seven Nanobodies in clinical development and we are on track internally to initiate a third Phase I study this year before the end of 2011."
Ablynx (Euronext: ABLX) is a biopharmaceutical company engaged in the discovery and development of Nanobodies®, a novel class of therapeutic proteins based on single-domain antibody fragments, for a range of serious and life-threatening human diseases, including inflammation, thrombosis, oncology and pulmonary disease. Today, the Company has over 25 projects in the pipeline and there are seven Nanobodies in clinical development. Ablynx has ongoing research collaborations and significant partnerships with major pharmaceutical companies, including Boehringer Ingelheim, Merck Serono, Novartis and Pfizer. The Company is headquartered in Ghent, Belgium and currently employs over 280 people.