Jason, if your so-called CNS people told you that it's a big fail, why did ZLCS get Orphan drug status for herpes zoster, and the longer term it's called postherpetic neuralgia (PHN). The virus may break out of nerve cell bodies and travel down nerve axons to cause viral infection of the skin in the region of the nerve. Now I'm no scientist, but isn't this all a part of the "CNS" as I know it as Central Nervous System? Sounds like your people are just little people in your head.
Sentiment: Strong Buy
Check out what Mark Versavel has been up to:
Alzheon Launches with Veteran Team and Funding to Accelerate Drug Development in Alzheimer’s Disease and Other Neurodegenerative Disorders
At the outset, Alzheon has a proven management team of seasoned leaders in the field of Alzheimer’s drug development as well as business transactions in neurosciences, including Martin Tolar, MD, PhD, Founder, President and CEO of Alzheon, John Hey, PhD, who has been appointed as Chief Scientific Officer of Alzheon, and Mark Versavel, MD, PhD, MBA, who will serve as Chief Medical Officer of Alzheon. Drs. Tolar and Hey bring to Alzheon their previous experience at CoMentis, Inc., where they played leadership roles in building the first clinical-stage beta-secretase inhibitor program for Alzheimer’s disease, which culminated in a landmark $1.1 billion transaction with Astellas Pharma in 2008. Dr. Versavel led clinical development of a number of drug candidates in the fields of neurology and psychiatry, including metrifonate for Alzheimer’s disease at Bayer, pregabalin (Lyrica) for neuropathic pain and fibromyalgia at Pfizer, and eslicarbazepine acetate for epilepsy and eszopiclone (Lunesta) for insomnia at Sunovion.
Here's a good one:
JN: "I spoke with 3 VERY qualified individuals who either know this mechanism well or write prescriptions for comparable drugs like gabapentin or PREGABALIN"
I see a lot of people desperately trying to determine what Z160 is comparable to. Gabapentin and pregabalin are *thought" to block all high voltage-activated calcium channels (L-, N-, P/Q- and R-type) through an as yet unconfirmed inhibition of the alpha-2-delta calcium channel accessory subunit.
N160 is thought to block only N-type, directly, thereby making it far more selective and therefore, in theory, it should cause fewer side effects (since it only hits one type of calcium channel).
Hopefully it is better than gabapentin or pregabalin which do have a lot of side effects.
No-one knows what concentration of Z160 will end up in the spinal cord in humans, or what particular variants of N-type channels exist there specifically, and therefore it is not possible to predict its efficacy.
The main thing though, is that no-one knows how it will perform in clinical trials. Not medics, not researchers, not "CNS people" whoever they may be. It is a fairly stupid thing to make such a statement since it is not possible to know this for any particular drug, even if it did have a similar mechanism of action to one currently on the market, which Z160 does not. It is a novel drug with a novel mechanism of action, unless of course you consider Ziconotide, which has to be administered directly into the spinal fluid, which Z160 does not.
Mark Versavel, MD, PhD, MBA, Chief Medical Officer
Dr. Versavel has 25 years of clinical development experience in neurology and psychiatry indications across the areas of clinical pharmacology, early and late phase clinical trials and support of marketed products. He has made major contributions to the development of a wide range of therapeutics which offered innovations in the fields of neurology and psychiatry. At Bayer AG, he played leadership roles in the development of metrifonate in Alzheimer’s disease, new formulations for nimodipine in subarrachnoidal haemorrhage, and controlled release formulations for ipsapirone in anxiety. At Schering AG, he was the core clinician for the Phase 2 development of an AMPA antagonist in stroke and the evaluation of betaferon in multiple sclerosis. At Pfizer, he was responsible for the Phase 3 international development of
(Lyrica) in neuropathic pain and fibromyalgia, and for pediatric studies with ziprasidone in schizophrenia and bipolar disorder. At Sunovion (previously Sepracor), he led the Phase 3 and NDA submission of eslicarbazepine acetate (Stedesa) in epilepsy and provided medical affairs direction for eszopiclone (Lunesta) in insomnia.