Orphan Drug Catalyst Pushing DARA Shares Toward Possible Technical Break-Out
LOS ANGELES, CA -- (Marketwire) -- 02/19/13 -- DARA Biosciences
(NASDAQ: DARA), a specialty pharmaceutical company focused on
oncology and oncology supportive care products, is expecting to hear
soon on the status of its Orphan Drug application submitted to The
Food and Drug Administration (FDA) in November of last year for its
drug KRN5500, which is being studied for the treatment of chronic
chemotherapy-induced peripheral neuropathy (CCIPN).
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(R), Revlimid(R), Velcade(R), 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
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
-- 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
Disclosure: Author Scott Matusow is Long DARA.
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