Multicenter prospective nonrandomized controlled clinical trial to prove neuro-therapeutic effects of granulocyte colony-stimulating factor
for acute spinal cord injury: analyses of follow-up cases after at least 1 year.
Pegfilgrastim is a long-acting formulation of oncology medicine filgrastim (granulocyte colony-stimulating factor
, or G-CSF).
Savara announced completion of the target enrollment of 135 patients in IMPALA, its global pivotal Phase 3 clinical study evaluating its lead product candidate Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor
, for the treatment of autoimmune pulmonary alveolar proteinosis, or aPAP.
ARRY-382 is a highly selective oral inhibitor of the Colony-stimulating factor
1 receptor (CSF1R) kinase.
The company stated that the Phase 3 GENESIS trial is aimed at evaluating the safety, tolerability and efficacy of the combination treatment of BL-8040 and granulocyte colony-stimulating factor
(G-CSF), as compared to the control arm of placebo and G-CSF.
BioLineRx announced results from the lead-in period of the GENESIS trial, a double-blind, placebo-controlled Phase 3 trial comparing BL-8040 in combination with granulocyte colony-stimulating factor
, to G-CSF alone, for the mobilization of hematopoietic stem cells used for autologous transplantation in multiple myeloma patients.
The company also has the largest number of breast cancer compounds in development, including BYL719 (alpelisib), an alpha-specific PI3K inhibitor; LSZ102, an oral SERD; LJM716, a fully human, anti-HER3 IgG1 antibody; and MCS110, a colony-stimulating factor
1 (CSF1) inhibitor.
This phase is expected to enroll an expanded cohort of approximately 10 additional patients.VBI-1901 is administered intradermally and is adjuvanted with granulocyte-macrophage colony-stimulating factor
, a potent adjuvant that mobilizes dendritic cell function.
F-627 (Benegrastim) is a recombinant human granulocyte colony-stimulating factor
(rhG-CSF) dimer that has a best-in-class potential to manage chemotherapy-induced neutropenia (CIN) in cancer patients.