Newswise — Raleigh, NC, October 10, 2011 – DARA BioSciences, Inc. (NASDAQ:DARA) today announced the Journal of Pain and Symptom Management, an internationally respected, peer-reviewed journal, has published results of a Phase II safety and efficacy study of KRN5500 for the treatment of neuropathic pain in patients with cancer. The study showed KRN5500 demonstrated a statistically significant improvement in the relief of neuropathic pain versus placebo. The Phase II trial was designed as a double-blind, placebo-controlled, randomized, dose escalation study. Refractory neuropathic pain of any etiology was acceptable for study entry. Refractory was defined as failure to achieve adequate relief from at least two commonly used treatments for neuropathic pain. The FDA recently designated KRN5500 as a Fast Track Drug. The 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 unmet medical need.
At study endpoint, KRN5500 exhibited a significant median decrease in pain intensity from baseline of 24% compared with 0% for placebo (P=0.03). The median for largest weekly reduction in target pain intensity was 29.5% for KRN5500 and 0% for placebo patients (P=0.02). Fifty percent of KRN5500 patients achieved ≥30% improvement in pain intensity compared to 14% of placebo patients. Eighty-nine percent of patients had painful chemotherapy-induced peripheral neuropathy (a very difficult treatment problem) among other possible etiologies.
The journal article concludes, “KRN5500 demonstrated safety at dose levels providing first therapeutic evidence for treatment-resistant (refractory) neuropathic pain in patients with advanced cancer, although causing transient GI side effects that were generally manageable. Despite the relatively small sample size, statistically significant and clinically meaningful improvements in pain were observed in patients treated with KRN5500 when compared to placebo.”
“The continuing recognition of KRN5500’s potential as an important treatment for a very difficult condition is extremely gratifying. First, KRN5500 was granted FAST Track drug designation by the US FDA and now to have results of this clinical study published in a well recognized, peer-reviewed journal is exceptional,” said Richard A. Franco, Chairman and CEO of DARA BioSciences.
The article is available online at http://www.jpsmjournal.com/article/S0885-3924(11)00382-4/fulltext.
About the Journal of Pain and Symptom Management
The Journal of Pain and Symptom Management is an internationally respected, peer-reviewed journal and serves an interdisciplinary audience of professionals. It is the official Journal of the U.S. Cancer Pain Relief Committee, the American Academy of Hospice and Palliative Medicine, and the National Hospice and Palliative Care Organization.
About Neuropathic Pain and the Cancer Patient
Neuropathic pain is a common pain syndrome for patients with cancer, and the etiology can include diverse conditions such as diabetic neuropathy, post-herpetic neuralgia, trauma, HIV/AIDS, as well as cancer-related neuropathy secondary to tumors, surgery, radiotherapy, and chemotherapy, as well as toxic effects from a number of other medications. More than one pathophysiologic mechanism may underlie neuropathic pain symptoms in cancer patients, making this population more difficult to treat effectively. In addition, some experts in the field consider neuropathic pain to be more resistant than nociceptive (mechanical or inflammatory) pain to standard analgesic treatments.
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. 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 (CIPN) is the most common cause of neuropathic pain in patients with cancer, and in particular, for those patients receiving multi-agent chemotherapy.
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. 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 and is sometimes the limiting factor in being able to provide effective treatment for cancer. To the extent that painful CIPN can become intolerable, and effective treatments are not available, it can actually become a life-threatening side effect of chemotherapeutics.
Although this type of pain sometimes responds well to standard analgesic treatments, currently approved analgesic 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. In recognition of this unmet medical need, the FDA recently granted “Fast Track” status to KRN5500. 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 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 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. 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 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.
Investor Contact: Cameron Associates, Inc.Kevin McGrath212.245.4577Kevin@cameronassoc.com