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https://scr.zacks.com/News/Press-Releases/Press-Release-Details/2016/NSPX-GenSpera-Changes-Name-to-Inspyr-Therapeutics-Focused-on-Development-of-Mipsagargin-for-Multiple-Cancer-Indications-article/default.aspx
Mipsagargin Development Plan in HCC
Inspyr now has the final report and full data set from the Clinical Research Organization that conducted the HCC Phase 2 trial. With the full data set, the company can now conduct more definitive discussions with potential corporate partners that they had previously engaged. The plan is to move into a large, international Phase 3 trial after a partnership agreement is signed, however the company is also prepared to initiate the Phase 3 trial alone.
From a strategy standpoint, the unique mechanism of action offered by mipsagargin means that the drug could be paired with another therapeutic to increase the overall efficacy. Mipsagargin is a targeted chemotherapeutic agent, thus the side effects typically seen with chemotherapeutic agents, particularly in regards to reduction in leukocytes, are not seen with mipsagargin treatment. This means that pairing mipsagargin with an immuno-oncology agent, which relies on a healthy immune system to drive an anti-cancer response, could be a good fit for the drug.
Mipsagargin may also be a good fit for pairing with trans-arterial chemo-embolization (TACE), which is the standard of care for intermediate stage HCC, particularly in Asia (Bruix et al., 2011). TACE has been previously combined with sorafenib in a number of trials, which showed an improvement in overall survival, albeit with increased side effects (Zhang et al., 2014). TACE leads to a hypoxic environment in the tumor, which ultimately leads to an increase in angiogenesis that can lead to tumor recurrence (Sergio et al., 2008). Since mipsagargin targets PSMA, which is overexpressed in the vasculature (blood vessels), it seems logical that an increase in blood vessel formation induced by TACE could be counteracted by mipsagargin, thereby making both treatments more effective when used together.
Whatever path the company decides to take, we believe there will be a definite focus on the Asian market, as that is where a majority of the liver cancer cases are located, and if mipsagargin is ultimately used in combination with TACE, where most of those procedures are performed. Before beginning a Phase 2b/3 trial, the company will need to conduct a small Phase 1/2 clinical trial in East Asian patients, as we believe they will make up the majority of patients in the global Phase 3 trial. This will likely be a dosing and pharmacokinetic study that could start in the first half of 2017 and be completed within nine months. The global Phase 2b/3 study could then initiate after the completion of the East Asian study, which we estimate would be late 2017 to first half of 2018.
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