DARA BioSciences, Inc. announced that its investigational drug KRN5500 has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neuropathic pain in patients with cancer.

The FDA's Fast Track programme 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 programme  is to get important drugs to the patient earlier.

New Drug Applications (NDA) for products in the Fast Track programme normally receive priority review. Information reported by the US 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 US 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, MD, director of the Duke Cancer Care Research Programme at the Duke University Medical Centre 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 per cent 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.

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).

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.

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.