KRN5500 Granted Fast Track Designation by the U.S.FDA
Newswise — Raleigh, NC –September 16, 2011 -- Thanks to greater awareness, earlier detection and improving therapeutic agents, people with cancer are living longer than ever before. One of the consequences of living longer is the symptom burden of cancer survivorship, which may have a substantial impact on quality of life for many survivors. One such burden is the pain syndromes resulting from cancer treatments. Chemotherapy-induced neuropathic pain is a neurotoxic effect of some chemotherapeutic agents such as paclitaxel, vincristine, cisplatin, oxaliplatin, thalidomide and bortezomib.
DARA BioSciences, Inc. (NASDAQ: DARA) is studying a new medication, KRN5500, for neuropathic pain in cancer patients and has reported positive results from a Phase II study. KRN5500 met its primary end-points of reduction of pain and safety.
KRN5500 is a novel spicamycin derived, non-narcotic/non-opioid/non-narcotic, analgesic agent produced by Streptomyces alanosinicus. 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). Study results showed KRN5500 to be both statistically and clinically significant in alleviating neuropathic pain, reaching its primary end-point – reduction of pain from baseline.
As a result of the promising results of the first Phase II study and the urgent unmet medical need, the National Cancer Institute (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 (CIPN). This study, in 40 patients, is planned to begin in 2011. Under this Agreement, the NCI will fund the costs of the study and DARA will supply drug and placebo. NCI will utilize its established national network of investigators (Community Clinical Oncology Program – CCOP) to conduct the study.
The U.S. FDA recently granted the KRN5500 program Fast Track designation for treatment of chemotherapy-induced neuropathic pain. The Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical need. Fast Track, Accelerated Approval and Priority Review information can be found at http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm.
“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.
About KRN5500 and Neuropathic PainKRN5500 is a novel non-opioid/non-narcotic analgesic agent, a semi-synthetic derivative of spicamycin:(6-[4-Deoxy-4-[(2E,4E)-tetradecadienoylglycyl]amino-L-glycero-beta-L-manno-heptopyranosyl]amino-9H-purine). Neuropathic pain has multiple etiologies, including direct nerve trauma, infectious disease (e.g., herpes zoster), metabolic disease (e.g., diabetes) and drug-induced neuropathies (e.g., chemotherapy). Chronic neuropathic pain is characterized by an abnormal hypersensitivity to innocuous as well as noxious stimuli, and often persists after initial tissue damage and inflammation appear to have healed. Painful neuropathy is more commonly caused by non-traumatic conditions than by direct nerve trauma.
Prevalence of neuropathic pain in patients that have been treated for cancer is reported to be in the range of 40%. Neuropathic pain in this population has multiple etiologies, including side effects from cancer treatments. Chemotherapy-induced Peripheral Neuropathy is the most common cause of neuropathic pain in patients with cancer, and in particular, for those patients receiving multi-agent chemotherapy. Clinically, neuropathic pain is difficult to manage and can have a profound impact on quality of life. Although this type of pain sometimes responds well to standard analgesic treatments, currently approved therapeutic agents can have intolerable side effects that prevent reaching the most effective dose. Thus, there is continued need to develop safe and more effective drugs to treat chronic neuropathic pain.
The FDA recently granted Fast Track Status to DARA for the KRN5500 program for treatment of chemotherapy-induced neuropathic pain. The Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical need.
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 studies 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 an y 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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