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A Decision Soon On KRN5500?
DARA Bio has been developing KRN5500 for almost a decade now. It's one of the last surviving pieces of the old DARA Bio from before new management took over in December 2011 and dramatically shifted the company's focus from mass-market opportunities in diabetes, cancer, and autoimmune disease to the current focus on oncology supportive care. KRN5500 an intravenous semisynthetic derivative of the nucleoside-like antineoplastic antibiotic spicamycin, originally isolated from the bacterium Streptomyces alanosinicus. It has the potential to be a breakthrough, non-opioid medicine for the treatment of neuropathic pain in cancer patients, or more specifically, chronic chemotherapy-induced peripheral neuropathy (CCIPN).
KRN5500 was originally developed by Japan's Kirin Brewery in an effort to identify new anti-cancer agents that induce apoptosis and differentiation of myeloid leukemia cells. The work was performed in collaboration with the Massachusetts General Hospital (MGH), the National Cancer Institute (NCI), and Eastern Cooperative Oncology Group (OTC:ECOG) in the U.S. Preclinical data demonstrated that KRN5500 has significant in vitro activity against human chronic lymphocytic leukemia (CLL) cells, thus providing support for advancement into clinical trials for patients with CLL, as well as those with acute myeloid leukemia (AML) and solid tumors.
Four clinical trials have been conducted in cancer patients, including one in Japan and three in the U.S. A total of 91 patients with solid tumors have been treated with single IV KRN5500 doses of up to 21 mg/m2 and weekly doses of up to 42 mg/m2. Unfortunately, no objective antitumor response was observed at the maximum tolerated dose (MTD) in any of these programs. However, potent neuropathic pain reduction was observed in a significant number of patients. MGH published this data in Clinical Cancer Research in November 2003. An additional analysis of these finds was published in the Journal of Pain and Symptom Management in April 2012.
Based on these findings, KRN5500 was reformulated, specifically to remove excipients that caused gastrointestinal side-effects in the original cancer trials, and development was moved forward in CCIPN. CCIPN is a type of pain that results from nerve damage and is characterized by an abnormal hypersensitivity to innocuous, as well as noxious stimuli. This type of pain is extremely difficult to manage, fails to respond to standard analgesic interventions including opioids, and often worsens over time. There are currently no FDA approved treatments for CCIPN. Given the void in the market and peer-reviewed data supporting potential utility of the drug, the U.S. FDA granted Fast Track status for KRN5500 in CCIPN.
We see CCIPN as a nice market opportunity for DARA Bio. The overall neuropathic pain market is enormous, forecasted to grow to $6 billion by 2015. It is one of the more sought-after markets in the pharmaceutical industry, and Orphan Drug status makes the opportunity even more attractive given the seven years of market exclusivity noted above. Specific to this opportunity, neuropathic pain occurs in 30% of cancer patients, including up to 90% of patients with advanced cancer. The incidence and severity of CCIPN vary considerably for each neurotoxic agent, administered alone or in combination, but for vincristine, cisplatin, oxaliplatin, and paclitaxel, estimates are as high as 70% to 90%. As many as 60% of patients receiving docetaxel and 40% of those treated with carboplatin develop CCIPN.
According to the American Cancer Society, there are an estimated 12 million Americans living with active cancer and some 1.6 million new cases each year. Not all types of cancer results in neuropathic pain, and not all active cancer patients are on chemotherapy. But conservatively, if we assume that half of 30% noted above with neuropathic pain are due to chemotherapy and other neurotoxic agents, the market opportunity for KRN5500 is around 1.8 million patients!