Image: Sorrento Therapeutics
Pain from Arthritis and Cancer
The CDC estimates that 54.4 million people in the US have doctor-diagnosed arthritis. About one in four adults with arthritis report experiencing severe joint pain related to arthritis, while nearly nearly half of adults with arthritis have persistent, chronic pain. Severe joint pain is more common among patients who have arthritis in combination with other chronic conditions including diabetes, heart disease and obesity, and among adults with a disability. More than 56% of adults with arthritis combined with serious psychological distress reported having severe joint pain.
The latest available statistics from The American Cancer Society estimate that nearly 17 million people are living with a cancer diagnosis in the US. Almost half of all cancer patients experience some kind of pain, according to the MD Anderson Cancer Center. The World Health Organization (WHO) estimates that one-quarter all cancer patients die with unrelieved pain. The American Cancer Society says there can be multiple causes of pain in cancer patients, from the cancer itself (e.g., spinal cord compression, bone pain, tumor pressing on organs) and from the cancer treatment (e.g., pain from surgery, pain from chemotherapy or radiation, pain from a missing body part).
Sorrento Therapeutics To Present Late Breaking Positive Clinical Trial Data on Arthritis and Cancer Pain Treatment at Two Prestigious Upcoming Pain Conferences
Sorrento announced today that it would be presenting late breaking Phase 1b/2 data on resiniferatoxin (RTX), a non-opioid therapy being investigated in osteoarthritis pain and cancer pain.
The Phase 1b/2 Osteoarthritis (OA) Knee Pain study completed enrollment of 93 patients, with no dose limiting toxicities observed and significant efficacy signal confirmed in expansion cohorts. The program is expected to move to Phase III pivotal studies in 2Q 2020.
The Phase 1b Cancer Pain study completed enrollment of initial cohorts (14 patients) with no dose limiting toxicities observed and efficacy signal confirmed. One expansion cohort (3 to 6 additional patients) was added to allow for better determination of the dosing regimen. The program is expected to move to a registrational study in 2H 2020.
Submissions for presentation of the positive clinical data from both trials were accepted as late breaking communications at the American Association of Pain Management (AAPM) meeting to be held in March 2020 and the Osteoarthritis Research Society meeting (OARSI) to be held in May 2020.
Given these initial results and the feedback from our investigators, we have started the process of planning our OA Knee pain and cancer pain pivotal studies to be initiated as soon as we are cleared to proceed by FDA. We believe this product candidate has the potential to rival the best selling pain drugs on the market, and the potential to make Sorrento an industry leader in pain management.
– Dr Alexis Nahama, Head of the RTX Business Unit for Sorrento.
RTX binds with TRPV1, the “capsaicin receptor,” and has been shown to effectively block pain signals from reaching the spinal cord. According to Sorrento, RTX is a thousand times “hotter” than pure capsaicin, with 16 billion Scoville units versus just 16 million, and has the potential to be a first-in-class drug addressing currently intractable pain in a novel and unique way by targeting the nerves responsible for the chronic debilitating pain signal transmission, without the undesirable side effects associated with high and repeated doses of opioids. RTX also has the potential to significantly reduce the amount and frequency of opioids use.
The mechanism of action for RTX is well understood and has been validated by extensive data in both animals and humans. RTX has been granted Orphan Drug Status by the FDA for the treatment of end-stage diseases, including intractable cancer pain.
Sorrento Rejects Latest Buyout Proposal From Private Equity Fund
The company also announced today that it has rejected the proposal received from a private equity fund on Jan. 9, 2020. The proposed buyout, at $7.00 per common share, was unanimously rejected by Sorrento’s board of directors as it “significantly undervalues Sorrento and is not in the best interest of the Company’s stockholders.”
Company in a Cash Crunch
As Sept. 30, 2019, Sorrento had about $34.7 million in cash and cash equivalents, compared to $158.7 million as of Sept. 30, 2018. Based on that annual run rate, there obviously isn’t much remaining in company coffers at present. So it will be a race from here between the company’s ability to raise financing at less than onerous terms and the continued hovering of private equity and other potential buyers.
In addition to its pain management therapeutic development, Sorrento has a potentially valuable early stage program in immuno-oncology. Additionally, the company has significant equity stakes in three other biopharmaceutical companies— Scilex, Celularity and ImmuneOncia—that have the potential to generate non-dilutive financing through licensing agreements.
At Monday’s closing price of $3.88 per share, the shares are an intriguing, if obviously risky, play. A lot of potential with not a lot of cash. It’s no wonder the private equity firms are circling. We’re encouraged by the early data in pain management, and will be watching closely for the next bid from an interested buyer.
Source: Equities News