Neuropathic pain, also known as nerve pain, is a type of chronic pain that occurs when nerves become injured or damaged by systemic disease, infections, autoimmune disease, or physical trauma due to toxins or injuries. It is estimated to effect more than 20 million people in the U.S. alone.1
"Sodium channels have long been known to play a significant role in the changes in neuronal excitability that lead to neuropathic pain," said
In a series of in vitro and in vivo preclinical studies examining the pharmacokinetics and efficacy of NKTR-171, NKTR-171 effectively blocks the inactivated state of sodium channel cells and, at the same time, demonstrates a significantly reduced brain to plasma ratio when compared to currently-approved sodium channel blockers. In well-validated animal models of persistent neuropathic pain, NKTR-171 shows superior or comparable efficacy to gabapentin. In addition, at analgesic doses, NKTR-171 did not significantly impair motor coordination in an established preclinical model of sedative potential in animals, suggesting that the therapeutic index (the ability to provide analgesia at doses that do not cause significant side effects) could potentially be greater for NKTR-171 than for currently available therapies.
These data presented in Abstract #81.06/JJ11 at the
http://www.nektar.com/pdf/pipeline/SFN_2012_NKTR_171_poster.pdf
About NKTR-171
NKTR-171 is a new sodium channel blocker that was designed to block sodium channels in the peripheral nervous system and was created using Nektar's advanced polymer conjugation technology. By selectively restricting the molecule to the periphery, NKTR-171 is intended to provide analgesia for neuropathic pain conditions without the severe sedation and other CNS side effects associated with current therapies used in the treatment of neuropathic pain. In preclinical testing, NKTR-171 demonstrates dose-dependent and effective pain relief without exhibiting sedative effects at analgesic doses.
About Neuropathic Pain
Neuropathic pain, also known as nerve pain or peripheral neuropathy, is the result of nerve damage and can be caused by such diverse conditions as diabetes, shingles, cancer, HIV, multiple sclerosis and fibromyalgia, as well as injury or trauma to the nerves. According to the
Today, medicines that act by blocking sodium or calcium channels such as the gabapentinoids and anti-epileptic medications, are used in the treatment of neuropathic pain but are known to cause serious CNS-related side effects, such as sedation and dizziness. Sodium channel blockers, such as Lidocaine, are known to be effective in addressing peripheral nerve pain, however the lack of an oral form limits its utility2. In spite of the shortcomings of medications currently prescribed for neuropathic pain, total U.S. sales in 2011 were
About Nektar
Nektar's technology has enabled eight approved products in the U.S. or
Nektar is headquartered in
Cautionary Note Regarding Forward-Looking Statements (NEEDS UPDATING)
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of NKTR-171 based on preclinical data including the potential for NKTR-171 to exhibit reduced CNS side-effects associated with current therapies; our future plan to initiate a Phase 1 study for NKTR-171 some time in 2013; and the value and potential of certain other drug candidates in our R&D pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations
and assumptions regarding the potential of our drug candidates, the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) our statements regarding the therapeutic potential of NKTR-171 are based on preclinical data we have generated to date and further preclinical
studies may not confirm the results of this early data; (ii) prior to commencing human clinical studies for NKTR-171, we must complete toxicology studies and, as with any preclinical drug candidate, the timing and outcomes of toxicology studies could significantly and negatively impact continued development of NKTR-171 or Nektar's current estimate of the time period during which the Phase 1 clinical study would begin; (iii) NKTR-171 is in preclinical development and could fail at any time due to numerous unpredictable and significant risks related to safety, efficacy and other important findings that can negatively impact drug development particularly at this very early stage; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of our technology platform to potential new drug candidates such as NKTR-171, is
therefore very uncertain and unpredictable and could unexpectedly fail at any time; (v) patents may not issue from our patent applications for NKTR-171, patents (if issued) may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) the outcome of any existing or future intellectual property or other litigation related to Nektar's proprietary drug candidates including without limitation NKTR-171; and (vii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the
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2) NINDS Peripheral Neuropathy Fact Sheet (http://www.ninds.nih.gov/disorders/peripheralneuropathy/detail_peripheralneuropathy.htm)
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