GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Interferon gamma-1b overview

Human interferon gamma-1b (Actimmune, Immukin, Imukin) an interferon-gamma, is a single-chain polypeptide containing 140 amino acids produced by recombinant DNA technology. It is formulated as an injection for subcutaneous route of administration. It is indicated for the reduction of the frequency of serious infections in patients with chronic granulomatous disease (CGD) and for the reduction in the frequency of serious infections in patients with severe, malignant osteopetrosis. It is indicated for chronic granulomatous disease (CGD) in adults and children. The drug candidate is believed to stimulate the immune system to respond to injury or infection. It is a bio-engineered form of interferon gamma which is produced by genetically engineered E.coli bacterium containing the DNA which encodes for the human protein.

It is under development for the treatment of relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome, autosomal dominant intermediate osteopetrosis type II (ADO2), solid tumors including urothelial bladder cancer, melanoma, non-small cell lung cancer, small cell lung cancer,  head and neck cancer squamous cell carcinoma, ovarian cancer, triple-negative breast cancer (TNBC), gastric cancer, colon cancer, hepatocellular carcinoma, malignant mesothelioma, gastrointestinal stromal tumor, endometrial cancer, liposarcoma, chondrosarcoma and uterine sarcoma. The drug candidate was also under development for the treatment of idiopathic pulmonary fibrosis, Friedreich ataxia, cystic fibrosis, cirrhosis and liver fibrosis. The drug candidate is a cytotoxic and immunomodulator agent. It is formulated as an injection for subcutaneous administration. The inhalation drug formulation was under development for the treatment of Mycobacterium avium complex infection and renal cell carcinoma.

Clinigen overview

Clinigen is a pharmaceutical and services company that provides access to clinical trials, medicines and unlicensed and commercial supplies. The company’s products include dexrazoxane, crisantaspase, amifostine, foscarnet sodium, acetylcysteine, cholecalciferol, folic acid, gabapentin, glycopyrronium bromide, iloprost, and others. It carries out clinical trial services, partnering, IDIS-managed access, clinical supply management, and others. Clinigen‘s clinical trial services comprise packaging and labeling, direct-to-site delivery, global storage and distribution, ancillary supply sourcing, and controlled drug services. The company serves biotechnology and pharmaceutical companies; and healthcare professionals. It operates in Japan, the US, New Zealand, Australia, Singapore, South Africa, and the UK. Clinigen Group is headquartered in Burton-on-Trent, Staffordshire, the UK.

For a complete picture of Interferon gamma-1b’s drug-specific PTSR and LoA scores, buy the report here.

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