Likelihood of Approval and Phase Transition Success Rate Model – Poly-ICLC in Malignant Pleural Mesothelioma
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How likely is it that a drug will get approved? Will the drug transition to the next phase of its clinical pathway? This report provides you with the data that allows you to track and predict the specific likelihood of approval (LOA) and phase transition success rate (PTSR) of a drug using GlobalData’s proprietary machine learning algorithms developed using over 10 years of historical data.
Poly-ICLC in Malignant Pleural Mesothelioma Drug Details:
Poly-ICLC (Hiltonol) is under development for the treatment of colorectal cancer, pancreatic ductal adenocarcinoma, melanoma, squamous head and neck cancer, human papillomavirus (HPV)-associated HNSCC, sarcoma, malignant pleural mesothelioma, lymphomas including cutaneous T-cell lymphoma, B-cell lymphoma, merkel cell carcinoma, metastatic adenocarcinoma of pancreas, MMR-p colorectal cancer, metastatic pancreatic cancer, colon cancer, prostate cancer, HIV-1 infection, epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (first line therapy), recurrent or metastatic breast cancer, non-small cell lung cancer, solid tumors, bladder cancer, kidney cancer and low-grade glioma. It is administered intramuscularly, intradermally, intratumorally and subcutaneously. The drug candidate is a synthetic complex of carboxymethylcellulose, polyinosinic-polycytidylic acid and poly-L-lysine double-stranded RNA. Poly-ICLC is a viral mimic and broad activator of innate immunity. Poly ICLC may stimulate the release of cytotoxic cytokines and by inducing interferon-gamma production, may increase the tumoricidal activities of various immunohematopoietic cells. It activates the oligoadenylate synthetase (OAS) and the p68 protein kinase. It is also acts as TLR3 agonist. The drug was also under development for the treatment of brain tumor, anaplastic astrocytoma, anaplastic oligoastrocytoma, oligodendroglioma, glioblastoma multiforme, poxviridae infections, west nile virus infections, japanese encephalitis, dengue fever, yellow fever, st louis encephalitis, murray valley, orthopox virus infections, banzai viruses, smallpox, severe acute respiratory syndrome (SARS), acute myeloid leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML) and influenza.
Report Coverage
The data is segmented by drug name per indication and shows the current likelihood of approval for the drug compared to the indication benchmark and the industry benchmark.
The Likelihood of Approval data is updated regularly based on events that take place which impact the clinical development process and regulatory considerations. GlobalData’s proprietary machine learning models consider these events in real time, to produce quantitative changes to the LOA and PTSR along with qualitative reasoning why the likelihood of approval has changed.
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Reasons to Buy
- Predict the specific likelihood of approval and phase transition success rates of a drug using a combination of machine learning and proprietary models
- Get information on LOA and PTSR for competitors’ drugs to plan your clinical development, commercialization and marketing strategies
- Track event-driven changes in LOA and PTSR benchmarked against indication LOA/PTSR
- Use PTSR and LOA information and event-driven changes for your investment decisions.
Frequently asked questions
- Drugs which have been approved in the past 10 years
- Drugs which have failed during clinical development in the past 18 years
- Drugs which are currently in development
- Phase I, Phase II, Phase III, and Pre-Registration development stage
- Drugs must meet one of the following criteria to be included in the model:
- The developer has specified the US as an intended market for approval.
- The developer has not specified any country as an intended market for approval, i.e. the “Drug Geography” is listed as “Global”
- Innovator drugs and biosimilars
- Diagnostics, Imaging Agents, Biomarkers, stents and other drug delivery devices (covered in GlobalData’s Medical Intelligence Center).
- Nutraceuticals, dietary supplements, alternative medicines, imaging agents, radio emitter, transplants, transfusions, fillers, cosmetics, probiotics, antiseptics, antacids, mobilizing agents, veterinary drugs and drugs not seeking approval.
- Generic drugs
- Innovative drugs in Preclinical or Discovery Stage.
- Pipeline drugs sponsored by a Government or Institution.
- Drugs with a specific Drug Geography not the United States.
The probability of a drug ultimately receiving market authorization
The probability of a drug’s advancement to the next stage of clinical development
GlobalData’s Drug-Specific Likelihood of Approval (LoA) calculates the Phase Transition Success Rate (PTSR) and Likelihood of Approval (LoA) customized to individual drug. The model uses a combination of Machine Learning (ML) and a GlobalData proprietary algorithm to process data points from the Drugs, Clinical Trials, Regulatory Milestones, Company, and Financial databases.
Inclusion
Data Scope:
Drug Phase Scope:
Drug Geography Scope:
Drug Type Scope:
Entity Type Scope:
Only drugs in development by companies are included in the model.
Exclusion
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