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KRN5500

Treatment for: Chronic Chemotherapy Induced Peripheral Neuropathy

DARA BioSciences' KRN5500 Granted Orphan Drug Designation by FDA for Treatment of Multiple Myeloma

RALEIGH, NC -- (Marketwired) -- 06/16/14 -- DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care specialty pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatments, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the experimental compound KRN5500 for the treatment of multiple myeloma.

KRN5500 is a novel, intravenous, non-opioid, non-narcotic compound currently in Phase 2 clinical development. Earlier this year, KRN5500 received orphan status to be developed for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy (CCIPN) that is refractory to conventional analgesics in patients with cancer. In 2011, the FDA designated KRN5500 as a Fast Track program which expedites the development pathway and consideration for priority review. Orphan Drug Designation provides DARA with seven years market exclusivity from the time of approval, tax credits, and the waiver of PDUFA filing fees, as well as access to federal grants.

"This second orphan drug designation for our key development asset KRN5500 allows us to approach the actual treatment of multiple myeloma, whereas the CCIPN designation is specific to neuropathy. It is noteworthy in this regard that up to 20% of myeloma patients have intrinsic peripheral neuropathy, an incidence that increases to the range of 75% in patients treated with neurotoxic drugs such as thalidomide or bortezomib. We believe this myeloma-specific orphan designation enhances both the viability and the future market opportunity for this valuable pipeline product," said David J. Drutz, M.D., Chief Executive Officer and Chief Medical Officer of DARA BioSciences.

The favorable consideration of myeloma as an orphan indication for KRN5500 was supported by a comprehensive publication in 2012 by an independent group of academic investigators, which demonstrated its therapeutic potential in both in vitro and in vivo experiments in which KRN5500, a spicamycin derivative, exhibited anti-myeloma effects through impairing both myeloma cells and osteoclasts.

Dr. Drutz continued, "We greatly appreciate the expeditious review and approval of this additional KRN5500 orphan designation application by the FDA's Office of Orphan Product Development, which provides an important step towards the potential treatment of multiple myeloma and one of its major complications. This second orphan drug designation underscores the value of this asset and strengthens DARA's resolve and positioning in the ongoing pursuit of partnering opportunities to assist in funding the clinical advancement and development pathway of KRN5500."

Multiple myeloma is a hematologic cancer (or cancer of the blood) and the second most common blood cancer after non-Hodgkin's lymphoma. The American Cancer Society estimates that more than 24,000 new cases of the disease will be diagnosed in 2014. The FDA grants orphan drug designation to therapeutics intended to treat diseases that affect fewer than 200,000 people in the United States.

About DARA BioSciences, Inc.

DARA BioSciences Inc. of Raleigh, North Carolina, is an oncology supportive care pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatments.

Safe Harbor Statement

All statements in this press release that are not historical are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and are subject to risks and uncertainties. Forward-looking statements are based on the current expectations, estimates, forecasts and projections regarding management's beliefs and assumptions. In some cases, you can identify forward looking statements by terminology such as "may," "will," "should," "hope," "expects," "intends," "plans," "anticipates," "contemplates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the negatives of those terms. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption "Risk Factors" in DARA's most recent Annual Report on Form 10-K, filed with the SEC on February 4, 2014, and DARA's other filings with the SEC from time to time. Those factors include risks and uncertainties relating to DARA's ability to realize the desired benefits of Orphan Drug Designation and Fast Track designation for KRN5500, DARA's ability to timely commercialize and generate revenues or profits from Soltamox, Gelclair, Bionect or other products given that DARA only recently hired its initial sales force and DARA's lack of history as a revenue-generating company, DARA's ability to achieve the desired results from the agreements with Mission and Alamo, FDA and other regulatory risks relating to DARA's ability to market Soltamox, Gelclair, Bionect or other products in the United States or elsewhere, DARA's ability to in-license and/or partner products, DARA's current cash position and its need to raise additional capital in order to be able to continue to fund its operations, DARA's ability to raise sufficient capital and on favorable terms and the stockholder dilution that may result therefrom, the current regulatory environment in which DARA sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA's intellectual property and the intellectual property of others, the potential delisting of DARA's common stock from the NASDAQ Capital Market, and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission ("SEC"). Copies of DARA's filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Source: DARA BioSciences, Inc.

Posted: June 2014

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