SOURCE: BioMedReports


February 19, 2013 08:06 ET

Orphan Drug Catalyst Pushing DARA Shares Toward Possible Technical Break-Out

LOS ANGELES, CA--(Marketwire - Feb 19, 2013) -  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®, 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
  • 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.

The full version of this report complete with a technical analysis chart can be found here:

Healthcare investors and Biotech traders interested in accessing BioMedReports' new complete database of clinical trials and upcoming FDA and world-wide regulatory decisions which can be used to make more profitable trades and see upcoming catalysts can go to:

Follow Us

News developments and live healthcare sector updates are available constantly via twitter at:

About BioMedReports.Com

BioMedReports is a news and research portal covering financial biotech news for the entire Healthcare Sector of the market. BioMedReports is not paid or compensated to report the news and developments of publicly traded companies. BioMedReports sells a premium product for subscribers and full disclosures and information about the stocks and news mentioned in this news release are available at BioMedReports.Com

Contact Information

  • Media Contacts Only:
    M. Davila
    Assistant Editor
    e-mail: Email Contact