Date: 2011-06-29
Type of information: Initiation of the trial
phase: 1
Announcement: initiation
Company: Ablynx (Belgium)
Product: ALX-0651 (anti-CXCR4 Nanobody)
Action mechanism:
Disease: stem cell mobilisation
Therapeutic area:
Country:
Trial
details: 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.
Latest
news: Ablynx 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.
