DARA BioSciences Receives Fast Track Designation From the U.S. FDA for KRN5500 for the Treatment of Chemotherapy-Induced Neuropathic Pain in Patients With Cancer

A Phase II Double-Blind, Placebo-Controlled Study of KRN5500 in Patients With Cancer Resulted in Positive Clinical Outcomes

RALEIGH, N.C., Aug. 18, 2011 (GLOBE NEWSWIRE) -- DARA BioSciences, Inc. (Nasdaq:DARA) announced today that its investigational drug KRN5500 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neuropathic pain in patients with cancer. 

The FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address the unmet medical need (Fast Track Drugs). The purpose of the program is to get important drugs to the patient earlier.

New Drug Applications (NDA) for products in the Fast Track program normally receive priority review. Information reported by the U.S. FDA states that for the years 1993 to 2003 the median time required to review a priority drug was reduced approximately by half vs. standard review. In addition, the FDA may now consider KRN5500's U.S. NDA submissions on a rolling basis. This process permits DARA to submit, and the FDA to review, sections of the NDA in advance of DARA's completing entire submission for marketing approval. The partial submission and review process may result in additional time saved. Fast Track status also entitles DARA to more frequent correspondence and meetings, which can facilitate faster answers to questions and additional assistance with development direction and study design.

DARA earlier reported positive results of its Phase II clinical trial (DTCL100), which met its primary endpoints of reduction of pain and safety and was superior to placebo (p=0.03). Based largely on these positive findings, the National Cancer Institute (NCI) is partnering with the Company to initiate a second Phase II study, which it anticipates will commence later this year.

Amy P. Abernethy, M.D., Director of the Duke Cancer Care Research Program at the Duke University Medical Center said, "We see a lot of patients with chemotherapy-induced neuropathic pain. They are a group of people that I find personally distressing to treat because they've got such difficult problems and many of them actually have long lives ahead of them, but have severe pain problems. No matter where they are in the course of their illness I think that KRN5500 holds promise as a potential help."

"The FDA Fast Track designation for KRN5500 is a significant positive step for the thousands of cancer patients who suffer this unremitting pain from a number of causes including from their chemotherapy," said Richard A. Franco, RPh, Chairman and CEO of DARA BioSciences. "This is a most serious condition in need of new treatment options. Current estimates show as many as 40-50% of cancer patients receiving chemotherapy endure this condition and a certain portion of these patients endure relentless chronic pain requiring treatment even after they recover from their cancer. CIPN is also a dose limiting side effect of many commonly used chemotherapeutics. We are very encouraged by the initial clinical results, our partnership with the National Cancer Institute (NCI) and now the FDA Fast Track Drug status," he added.

For more information about DARA BioSciences and KRN5500 go to www.darabio.com.

Additionally, Fast Track, Accelerated Approval and Priority Review information can be found at http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm.

About Neuropathic Pain and the Cancer Patient

Neuropathic pain is a common pain syndrome for patients with cancer. Chemotherapy-induced peripheral neuropathy is referred to as CIPN for short. CIPN is a major dose limiting side effect of many commonly used chemotherapeutic agents, including platinum drugs, taxanes, epotholones, vinca alkaloids, bortezomib and lenalidomide. It is a set of symptoms caused by damage to the nerves that are outside the brain and spinal cord. These nerves are called peripheral nerves, while the nerves in the spinal column are called central nerves. Peripheral nerves carry sensations (feeling) to the brain and control the movement of our arms and legs.   Chemotherapy-induced peripheral neuropathy can be a disabling side effect of cancer treatment. It is caused by some of the chemotherapy drugs used to treat cancer.

Chemotherapeutics travel through the whole body, and certain types can damage different nerves. Symptoms tend to start farthest away from the head, but move in closer as it gets worse. In most cases, people will notice CIPN symptoms in the feet, then later on in the hands. Symptoms may start in the toes, but move on to the ankles and legs. Likewise, symptoms can move up over time from the fingers to the hands and arms. CIPN most often affects both sides of the body. When it affects both hands and both feet, doctors call it a "stocking-glove distribution." CIPN can begin any time after treatment starts and often gets worse as treatment goes on.

Certain chemo drugs are more often linked to CIPN. These include:

  • Platinum drugs like cisplatin, carboplatin, and oxaliplatin;
  • Taxanes including paclitaxel (Taxol®) and docetaxel (Taxotere®);
  • Epotholones such as ixabepilone (Ixempra®);
  • Plant alkaloids such as vinblastine, vincristine, vinorelbine, and etoposide (VP-16);
  • Thalidomide (Thalomid®) and lenalidomide (Revlimid®);
  • Bortezomib (Velcade®).

About KRN5500 and Clinical Results

KRN5500 is a novel spicamycin derived, non-narcotic/non-opioid, analgesic agent produced by Streptomyces alanosinicus and is being studied for the treatment of neuropathic pain in cancer patients. A completed Phase II (DTCL100), double-blind, placebo-controlled, randomized, dose escalation study yielded positive results. The purpose of the study was to determine safety and efficacy of KRN5500 as treatment for neuropathic pain in patients with advanced cancer and neuropathic pain.

KRN5500 met its primary endpoints of safety and reduction of pain and was superior to placebo (p=0.03). Based on the results of this study and the urgent unmet medical need, the NCI entered into a Clinical Trials Agreement with DARA to further study KRN5500 for the prevention and treatment of chemotherapy-induced neuropathic pain in patients with cancer. Under this Agreement the NCI will fund the costs of the study and DARA will supply drug and placebo. This collaborative trial is scheduled to begin during the second half of 2011.

About DARA BioSciences, Inc.

DARA is a pharmaceutical development company that acquires high quality, promising therapeutic molecules in early stage development (late pre-clinical/Phase I) that has the potential to fill a significant medical need and represents a large commercial opportunity for participation in large and growing markets. The Company expedites development through proof-of-concept in humans (prior to Phase III) for subsequent partnering, sale or out-licensing to large healthcare and pharmaceutical companies. The effective implementation of this strategy has the potential to greatly enhance return on investment by properly designing drug studiers that will reduce event risks and cost of the drug development process.

Presently, the Company has two (2) lead drug candidates advancing through clinical trials. KRN5500 for the treatment of neuropathic pain in patients with cancer has successfully completed a Phase IIa study. DB959 for the treatment of type 2 diabetes and dyslipidemia has successfully completed a Phase Ia study and is nearing completion of a Phase Ib study. The Company plans to announce results during Q3 2011.

DARA has a number of promising pre-clinical drug candidates for future development and monetization which include:

Family of DPPIV Inhibitors - DB160 is a lead dipeptidylpeptidase (DPPIV) inhibitor. DPPIV is an enzyme that inactivates a key hormone involved in promoting control of blood sugar levels, thus giving people with diabetes better control of their blood sugar levels. 

Studies have demonstrated that potent DPPIV inhibitors may be beneficial with stem cell transplantation. The cell surface enzyme, DPPIV, is involved in a number of functions, including adhesion, apoptosis, immune regulation, signal transduction, degradation of incertins such as GLP-1 and as a suppressor in the development of cancer and tumors (Boonacker and Van Noorden. Eur J Cell Biol; 2003). Additional studies have demonstrated that DPPIV is involved with mobilization of hematopoietic stem cells and hematopoietic progenitor cells (Christopherson, Exp Hematol; 2003). In-vitro studies in mice have shown that inhibition of DPPIV activity on donor cells (either through deletion of the protein or through treatment with a DPPIV inhibitor) enhanced short-term homing, long-term engraftment, and mouse survival (Christopherson et al., Science; 2004).

DB900 is a series of compounds which are PPAR g/a/d agonists for the treatment of type 2 diabetes. These compounds activate genes involved in the metabolism of sugars and fats, thereby improving the body's ability to regulate blood sugar. These compounds have the potential to raise good HDL cholesterol, lower bad LDL cholesterol and lower triglycerides. They also have the potential to deliver weight loss.  

DB200 refers to a series of compounds that are inhibitors of CPT-1 for the topical treatment of psoriasis. This drug candidate has the potential to inhibit inflammation and the proliferation of skin cells, thus resulting in decreased reddening and less flaking of the skin. This program is currently not being resourced. Should development of DB200 resume, a clinical candidate will be selected from a number of strong lead compounds. 

Safe Harbor Statement

All statements in this news release that are not historical are forward-looking statements within the meaning of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Those factors include risks and uncertainties relating to DARA's current cash position and its need to raise additional capital in order to be able to continue to fund its operations, risks and uncertainties relating to the potential delisting of DARA's common stock from the NASDAQ Capital Market, risks and uncertainties relating to DARA's ability to develop and bring new products to market as anticipated, the current regulatory environment in which the company develops and 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, the intellectual property of others, 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. DARA expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in DARA's expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. DARA BioSciences and the DARA logo are trademarks of DARA BioSciences, Inc.

The drug discovery and development process is highly uncertain, and we have not developed, and may never develop, a drug candidate that ultimately leads to a commercially viable drug. Our most advanced drug candidates are in the early stages of development, and we do not have any drugs approved for commercial sale. Before a drug product is approved by the FDA for commercial marketing, it is tested for safety and effectiveness in clinical trials that can take up to six years or longer. Promising results in preclinical development or clinical trials may not be predictive of results obtained in later clinical trials. A number of pharmaceutical companies have experienced significant setbacks in advanced clinical trials, even after obtaining promising results in earlier preclinical and clinical trials. At any time, the FDA may place a clinical trial on clinical hold, or temporarily or permanently stop the trial, for a variety of reasons, principally for safety concerns. We or our collaborators may experience numerous unforeseen events during, or as a result of, the clinical development process that could delay or prevent our drug candidates from being successfully commercialized, including: (1) Failure to achieve clinical trial results that indicate a candidate is effective in treating a specified condition or illness in humans; (2) Safety issues, including the presence of harmful side effects; (3) Determination by the FDA that the submitted data do not satisfy the criteria for approval; (4) Lack of commercial viability of the drug; (5) Failure to acquire, on reasonable terms, intellectual property rights necessary for commercialization; and (6) Existence of therapeutics that are more effective.


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