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cover of episode Rewiring Recovery: Advancing Nervous System Repair With NervGen’s Mike Kelly

Rewiring Recovery: Advancing Nervous System Repair With NervGen’s Mike Kelly

2025/4/8
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Richard Jacobs: 我正在采访NervGen的CEO Mike Kelly，我们将讨论神经系统修复和脊髓损伤修复。 Mike Kelly: 我在制药行业工作了30年，积累了丰富的商业和管理经验，目前在NervGen公司致力于攻克神经系统疾病的治疗难题。NervGen的疗法源于Jerry Silver博士的研究，该技术旨在通过抑制神经修复的抑制分子来促进神经再生，目前主要应用于脊髓损伤的治疗。我们正在进行一项针对脊髓损伤患者的1b/2a期临床试验，试验分为慢性损伤组和亚急性损伤组，旨在评估NVG-291对患者运动功能和神经信号传导的影响。临床试验的主要终点是评估药物对神经信号强度的影响，次要终点是评估患者的运动功能改善情况，我们希望看到动物模型中观察到的运动能力和功能改善能够在人体中得到体现。脊髓损伤会导致轴突受损和髓鞘受损，从而影响神经信号传递。我们的药物旨在促进髓鞘再生、轴突再生和神经可塑性，从而改善神经信号传递和运动功能。大量的动物模型实验数据表明，NVG-291能够改善动物的运动功能，我们希望这种效果能够在人体试验中得到验证。我们正在进行的临床试验结果将在6月初公布，如果结果积极，我们将与FDA讨论下一步的开发计划，并争取快速审批。该药物的作用机制是特异性地抑制CSPGs的活性，不会影响正常CSPGs的活性，因此副作用较小。一期临床试验显示该药物耐受性良好，主要副作用是注射部位反应。如果该药物获得FDA批准，预计将主要由康复科医生用于脊髓损伤患者的治疗。目前临床试验主要针对颈椎损伤患者，动物模型实验也显示该药物对胸椎损伤有效。大家可以通过NervGen官网关注研发进展。

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Chapters
This chapter introduces Mike Kelly, CEO of NervGen, and provides an overview of NervGen's innovative technology for nervous system repair, stemming from the work of Dr. Jerry Silver. The company's lead product candidate, NVG-291, is currently undergoing clinical trials for spinal cord injuries, and shows promise in various neurological conditions.
  • NervGen's technology originates from Dr. Jerry Silver's research on molecules inhibiting nervous system repair.
  • NVG-291, the lead product candidate, is in clinical development.
  • Preclinical studies show positive effects in various conditions including spinal cord injury, stroke, and multiple sclerosis.

Shownotes Transcript

In today’s episode, we discuss nervous system repair in the context of traumatic injury and disease with Mike Kelly, the President and CEO of NervGen. With more than three decades of pharmaceutical experience under his belt, Mike plays instrumental roles in the creation, development, and strengthening of a number of pharma companies. 

What’s his primary goal? To constantly innovate medical technology for people across the globe…

NervGen is a clinical-stage biotech company advancing innovative therapies for neurological recovery. Their lead drug candidate, NVG-291, is currently being evaluated in a Phase 1b/2a clinical trial for spinal cord injury. Additionally, they have launched preclinical studies for NVG-300 – a promising new development candidate, in models of ischemic stroke, amyotrophic lateral sclerosis (ALS), and spinal cord injury.

Hit play to find out:

Where NervGen’s technology comes from. What nervous system regeneration looks like at a molecular level.  How clinical trials progress from animals to humans.  The ways that biomarker results can indicate breakthroughs in science. 

Be sure to follow along with NerGen’s cutting-edge work by visiting their website)!

Episode also available on Apple Podcast: http://apple.co/30PvU9C)

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