Therapy Areas: Hereditary Disorders
JHL Biotech to launch three-arm pharmacokinetic study in healthy volunteers in Bulgaria to treat colorectal, lung and ovarian cancers
23 February 2018 -

Biopharmaceutical startup JHL Biotech Inc reported on Thursday the receipt of approval from the European authority, Bulgarian Drug Agency for a Phase I Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149.

Following the approval, the company will launch a three-arm pharmacokinetic study in healthy volunteers in Bulgaria beginning March 2018.

The company said that the data from this trial will support the rapid development and commercialisation of JHL1149. JHL1149 would provide an affordable alternative to bevacizumab, a biologic used to treat many cancers, the most common of which are metastatic colorectal cancer, lung cancer and ovarian cancer.

Currently, the company expects several biosimilars to be in clinical trials: Rituximab biosimilar (JHL1101) to treat rheumatoid arthritis and Non-Hodgkin's Lymphoma; Dornase alfa biosimilar (JHL1922) to manage symptoms of cystic fibrosis; as well as Trastuzumab biosimilar (JHL1188) to treat breast cancer.

Login
Username:

Password:


Related Headlines

Vertex Pharmaceuticals receives European Commission approval for ORKAMBI (lumacaftor/ivacaftor) To treat children with cystic fibrosis aged 1 to <2 years old

cystetic Medicines doses first healthy volunteer in CM001 Phase one clinical trial

Vertex Presents Data Demonstrating Significant Benefits of Long-Term Treatment with CFTR Modulators at the European Cystic Fibrosis Conference

First Patient Enrolled in Phase 3 Clinical Trial Evaluating ARINA-1 in Lung Transplant

Vertex and CRISPR Therapeutics Complete Submission of Rolling Biologics License Applications to the US FDA for exa-cel for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

Insmed completes adult patient enrolment in brensocatib pivotal ASPEN study

Vertex Receives FDA Clearance of Investigational New Drug Application for VX-264, a Novel Encapsulated Cell Therapy for the Treatment of Type 1 Diabetes

Aluna Raises USD 15.3m in Series B Funding

First Patient Dosed in Adaptive Phage Therapeutics' PHAGE Clinical Trial Evaluating Phage Therapy in Cystic Fibrosis-related Respiratory Infection

CF Foundation Invests Up to USD 15m in ReCode Therapeutics for Development of mRNA Therapy

Markels Named to Arcturus Therapeutics Board of Directors

SpliSense commences first-in-human, Phase 1/2 clinical trial of SPL84 to treat cystic fibrosis

Sionna Therapeutics receives approval from US Food and Drug Administration for Investigational New Drug application of SION-638

Arcturus Forges Collaboration with CSL to Develop and Commercialize Self-amplifying mRNA Vaccines

Vanda Pharmaceuticals VPO-227 granted US FDA Orphan Drug Designation for the treatment of cholera