LOS ANGELES, CA--(Marketwire - Feb 19, 2013) - DARA Biosciences (
KRN5500 is a novel, spicamycin-derived, non-opioid-non-narcotic intravenous pain therapeutic with promising clinical trial results in patients with chemotherapy-induced peripheral neuropathy (CIPN).
More than 70% of patients treated with taxane-class or platinum-class chemotherapeutic agents; at least 25% of those treated with vinca-class agents; and significant numbers of those treated with Thalomid®, Revlimid®, Velcade®, and a variety of other cancer drugs experience CIPN, which can be disabling and adversely affect quality of life.
There is presently no FDA-approved drug for CIPN.
In October, 2011, the U.S. FDA granted KRN-5500 Fast Track designation for CIPN, an indication with a market potential estimated at $2.5B.
Summary of Phase 2a clinical trial results:
- "A Spicamycin Derivative (KRN5500) Provides Neuropathic Pain Relief in Patients with Advanced Cancer: A Placebo-Controlled, Proof-of-Concept Trial"; Journal of Pain and Symptom Management http://digitalreprints.elsevier.com/issue/47166.
- Patients had failed on at least two previous pain therapeutics
- KRN5500 met primary endpoints: reduction of pain and safety
- Significantly more effective than placebo (p=0.03)
- Transient and manageable GI side effects
The stock is trading in a manner that hints at positive news concerning the Orphan Drug status application.
For example, the stock chart for DARA is forming a cup and handle breakout pattern with resistance at $1.20. Once past this level, the near term price target indicates a test of the prior high of $1.38. Measuring the cup and handle break indicates a move over $2 in the coming months.
Disclosure: Author Scott Matusow is Long DARA.
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- Pharmaceuticals & Drug Trials
- Food and Drug Administration
- peripheral neuropathy
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