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Sunday, February 17, 2019

Sorrento Provides A New Way To Treat Pain

Sorrento Therapeutics announced positive results from its phase 1b study using RTX to treat patients with osteoarthritis of the knee.
RTX is also being used to treat patients with terminal cancer pain.
Sorrento has cash of $135.4 million as of Sept. 30, 2018, and along with the 5-year term loan, it can fund its operations for at least another 2 years.
Sorrento Therapeutics (NASDAQ:SRNEannounced positive phase 1b results using its non-opioid product RTX (resiniferatoxin) to treat patients with osteoarthritis of the knee. It was a small study, but it still included a placebo as a counterpart to prove that the drug at least works. With the positive data obtained from this small study, Sorrento expects to initiate a pivotal study in 2019. This is not the only indication that is going to use RTX to treat pain. RTX will also be developed as a treatment for terminal cancer pain as well. This gives the drug a few indications to be tested in. The fact that a small study explored with a placebo went well means that it is now known the drug has modest efficacy. The next challenge will be to see if adding more patients in a larger study yields a similar outcome.

Phase 1b Data

The phase 1b study was known as PTVA-OA-001, and it recruited patients with moderate to severe osteoarthritis of the knee. This first study was necessary in that it was used to assess the maximum tolerated dose (MTD) that could be used for future studies. It also looked at safety and preliminary efficacy of RTX in patients with Osteoarthritis of the Knee. The efficacy of this trial was established using something known as the WOMAC index. This type of index is a questionnaire that is utilized to evaluate patients with Osteoarthritis of the Knee. However, this index can also be used to measure other types of pain as well such as rheumatoid arthritis and fibromyalgia. Patients in the study and in each cohort either received an injection of RTX or placebo (saline). It was noted that patients treated with RTX obtained a mean pain score that was 4.7 points lower than control. This type of observation was made on the 10 point WOMAC pain scale on day 84. There are quite a few things that I noticed from this study that showed how powerful RTX is as a treatment for these patients. The first item to note is that the onset of pain reduction was obtained after only one day after administration with one dose of RTX. The second item is that this type of effect was observed with the lowest dose. There has not yet been any look at any of the higher doses in the study because, for the time being, they remain blinded. That didn’t stop Sorrento Therapeutics from advancing its clinical product. It has started to plan how it will set up its pivotal study, despite the fact that this smaller phase 2 study has not yet been completed. As the study gets toward the end, that will make it easier for the biotech to determine the most appropriate dose that should be used for the pivotal study. If the final results from the phase 1b study and pivotal study pan out, then it may eventually give patients another treatment option for pain that is a non-opioid.

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