Progressive MS treatment phase III study update

Biotin is an emerging therapy for the treatment of secondary progressive MS.

Re: Progressive MS treatment phase III study update

Postby Jimpsull » Wed Apr 15, 2015 4:27 pm

If there was no opportunity to gouge us on price there would be less incentive to fund the clinical trials. Someone has to pay for the research. For now supplements are affordable (relatively). Let's cross the price bridge when we come to it. If the uninsured get desperate enough I'm sure they can find a source of biotin. Horse trainers use it by the scoop to enhance hooves and manes.
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Re: Progressive MS treatment phase III study update

Postby Jimpsull » Wed Apr 15, 2015 11:08 pm

http://enhancedbiotintrial.blogspot.com/

I'm keeping a log of my trial at the link above.
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Re: Progressive MS treatment phase III study update

Postby 1eye » Thu Apr 16, 2015 9:36 am

Jimpsull wrote:The pharma grade pure biotin I found was only about $166 per kg. that's 1000000 mg or about 333 days at 300 mg per day. But it would be hard to control dosing. Since the half life of biotin is about 2 hours and any excess gets pissed out, I want to divide my daily dosage evenly throughout the day.

I am thinking 10 mg per hour throughout the waking hours is about 180 mg per day. I got 600 10000mcg pills for $45 which will last me more than a month.

Reading the patent, results were seen at 100 mg a day in some case studies. Since they were divided in three doses I believe my hourly dosing plan will be more efficient- hopefully delivering 300mg results in 180 mg per day.

$45 per month is worth it to me to avoid dealing with measuring out 18 doses of 10 mg per day.

Since it took 2 - 12 months to see results I'm committing $90 - $540 for this trial. I dumped 5k on NUCCA on a leap of faith - this seems like a good calculated risk.

Jim



1 kg = 1000g = 1000000 mg. Divide 1000 g by .3 g an you get 3,333 doses. divide that by 365 days per year and you get 9 years and some.

You can only store it for 2 years, so buy say 250 g to avoid waste. Any compounding pharmacist can easily put that in 300 mg capsules for you, or if you want to time it, whatever size you want. You can buy capsules cheap, from pharmacists too, if you can wiegh the powder but that sounds like a lot of work. The LDN folks figured out how to portion it out by dissolving it in distilled water and subdividing that by volume. I don't know what the shelf life of that would be. Probably should refrigerate. You would likely put some number of teaspoons of it in a glass of orange juice.

it's silly to call something 10000 micrograms. Every time you add three zeroes, you change to a bigger unit, so as you say it's 10mg. But are you sure it's 100% biotin?
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Re: Progressive MS treatment phase III study update

Postby Jimpsull » Thu Apr 16, 2015 10:38 am

The pills are more than 10 mg however they contain 10 mg of biotin. The rest is filler. If I harm myself it will likely be due to overdosing on filler.
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Re: Progressive MS treatment phase III study update

Postby Jimpsull » Thu Apr 16, 2015 3:20 pm

I actually am concerned about the amount of filler I'm ingesting via 20 tablets per day (40 now at the 5 mg tablets).

Switching to zero filler vege capsules will raise the cost to around $200 / month. Charging ahead but considering modifications to reduce filler intake while keeping costs down.

Btw - compounding pharmacy wanted $300 / month, needed a script, 20 mg units, still used cellulose filler.
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Re: Progressive MS treatment phase III study update

Postby Jimpsull » Thu Apr 16, 2015 3:22 pm

One possibility is 20 x 5 mg. high dose may be more a function of trying to make it a patentable medicine than out of medical necessity.
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Re: Progressive MS treatment phase III study update

Postby PointsNorth » Fri Apr 17, 2015 10:05 am

Looks good.

Friday, April 17, 2015
MedDay announces its pivotal Phase III study of MD1003 in patients with Progressive Multiple Sclerosis meets primary endpoint

news
~ Detailed Phase III data will be presented at AAN Annual Meeting in Clinical Trials Plenary Session on April 24th 2015 ~

Paris, France, April 17 2015 - MedDay, a biotechnology company focused on the treatment of nervous system disorders, today announces that the primary endpoint was met in its pivotal clinical trial MS-SPI. MS-SPI investigated the efficacy and safety of MD1003, a highly-concentrated pharmaceutical-grade biotin administered at a dose of 300 mg /day, in the treatment of progressive multiple sclerosis.

The primary endpoint for the study was defined as the proportion of patients who improved at 9 months, with confirmation at 12 months. Detailed data will be presented for the first time at the Clinical Trials Plenary Session at The American Academy of Neurology (AAN) Annual Meeting, Washington DC, on Friday April 24th at 1200 EST.

"We are encouraged that the primary endpoint was met despite the very high bar for treatment response. This result, which will be disclosed at AAN on April 24th along with supportive analyses and safety data, suggests that MD1003 could be an important and efficacious treatment for primary and secondary progressive multiple sclerosis," said Prof. Ayman Tourbah, Principal Investigator of the study, CHU de Reims, Neurology, France.

"The trial design and dosing were discussed with US and European regulators and we are pleased the results demonstrate evidence of improvement at one year in patients with progressive worsening MS,” said Frédéric Sedel, MD, Chief Executive Officer of MedDay.

About MS-SPI

MS-SPI is a randomized, double-blind, multicenter, placebo-controlled (2:1) trial of MD1003, 300 mg/day, in patients with progressive MS who have demonstrated progression in the two years prior to enrolment.

A total of 154 patients with a baseline EDSS (Expanded Disability Status Scale) score of between 4.5 and 7 were enrolled from 16 MS reference centers across France. Treatment duration was one year.

The primary endpoint for the study was defined as the proportion of patients who improved at nine months (M9), with confirmation at 12 months (M12). Improvement was defined as either a decrease in EDSS (by at least 1 point for baseline EDSS ≤5.5 and 0.5 points for EDSS ≥6) or an improvement in TW25 (a timed 25-foot walk) of at least 20%. The comparison for each outcome was the best EDSS and TW25 scores obtained at the screening and randomisation visits.

The main secondary endpoints evaluate the effect of MD1003 in stabilizing or slowing down the rate of progression. These endpoints include the change in EDSS between M0 and M12, the proportion of patients with progression at M9 confirmed at M12 and the change in TW25.

MS is the most common disabling neurological disease among young adults, with first symptoms typically manifesting between 20 and 40 years of age. In the majority (85%) of cases, patients experience an initial phase of relapsing-remitting neurological dysfunction (RRMS), which typically evolves into a secondary progressive disease at a later point in the clinical course (SPMS). Once MS is in the progressive phase, individuals experience a gradual worsening of neurological disability leading to problems with vision, walking, incontinence, cognitive changes, fatigue, and pain. Primary progressive MS (PPMS) characterized by disease progression from onset is less common, affecting 10–15% of patients.

Despite these different initial clinical phenotypes, the time to reach certain disability milestones and the ages at which the milestones are reached are similar for patients with PPMS and SPMS. Recent guidelines have therefore proposed to group PPMS and SPMS within a single entity called “progressive disease”. The overall prevalence of patients with progressive disease is estimated to be at least 40% of all MS patients.

Full session details and data presentation listings for the 2015 Annual Meeting can be found through the AAN website:?www.aan.com/conferences/2015-annual-meeting.

-Ends-

About MD1003

MD1003 is an investigational medicine thought to have both pro-myelinotic effects and to enhance the supply of energy for nerve impulse transmission. MD1003 is an active pharmaceutical ingredient administered at a dose of 300 mg /day has patent protection in EU and US for dose and use in multiple sclerosis.

MD1003 has a mode of action which potentially influences two targets related to progressive MS: (1) it activates acetyl-CoA carboxylases (ACC1 and ACC2), the rate-limiting enzymes in the synthesis of fatty acids required for myelin synthesis, and (2) it activates the Krebs cycle in demyelinated axons to increase energy production.

MD1003’s proof of concept has been obtained in a pilot open label study involving 23 subjects with primary and secondary progressive MS. Results were positive with up to 90% of subjects exhibiting clinical improvement over time. Treatment efficacy was also assessed using electrophysiology studies and magnetic resonance spectroscopy. Results were published this year in the Journal of Multiple Sclerosis and Related Disorders. For more information on the study, please see: http://www.msard-journal.com/article/S2 ... 1/abstract.

Scientific Advisory Board

Prof. Alan Thompson (Chairperson, UCL, UK); Prof. Jack Antel (McGill, Canada); Dr Robert Fox (Cleveland, USA); Prof. Reinhard Hohlfeld (Munich, Germany); Prof. Jean Pelletier (Marseille, France); Prof. Per Soelberg Sorensen (Denmark); and Prof. Ayman Tourbah (Reims, France, principal investigator in the study).

About MedDay

MedDay is a privately held biotechnology company developing new drugs for nervous system disorders. The company was founded in 2011 by Frédéric Sedel, MD, PhD (Chief Executive Officer); and Guillaume Brion, MD (Chief Operating Officer). In April 2013, InnoBio, a biotechnology fund managed by BPIFrance, and Sofinnova Partners together invested in MedDay. The Company’s most advanced pipeline candidate is MD1003 for the treatment of primary and secondary progressive multiple sclerosis. For more information, please see: http://www.medday-pharma.com.

For more information, please contact: MedDay Pharmaceuticals

Email: contact@medday-pharma.com

Consilium Strategic Communications

Mary-Jane Elliott, Jonathan Birt, Ivar Milligan, Laura Thornton

Tel: +44 (0)20 3709 5700
Email: medday@consilium-comms.com
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Re: Progressive MS treatment phase III study update

Postby 1eye » Fri Apr 17, 2015 1:21 pm

Now don't all go off and buy it all up at once, and drive up the price! :-D
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Re: Progressive MS treatment phase III study update

Postby NHE » Fri Apr 17, 2015 9:24 pm

Jimpsull wrote:I actually am concerned about the amount of filler I'm ingesting via 20 tablets per day (40 now at the 5 mg tablets).

Switching to zero filler vege capsules will raise the cost to around $200 / month. Charging ahead but considering modifications to reduce filler intake while keeping costs down.

Btw - compounding pharmacy wanted $300 / month, needed a script, 20 mg units, still used cellulose filler.


There's at least one company that's selling biotin with a coconut oil filler supposedly to increase absorption. I've never heard of them before and know nothing about them though.

http://www.amazon.com/Enhanced-Coconut- ... 00T56FQAE/
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Re: Progressive MS treatment phase III study update

Postby Jimpsull » Fri Apr 17, 2015 10:58 pm

Coconut oil contains saturated fat - not swank diet friendly
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Re: Progressive MS treatment phase III study update

Postby NHE » Fri Apr 17, 2015 11:24 pm

Jimpsull wrote:Coconut oil contains saturated fat - not swank diet friendly


Not all saturated fats are created equally. The saturated fat in coconut oil is mostly in the form of medium chain triglycerides consisting of 6-12 carbon fatty acids. 48% of this is lauric acid which is rapidly metabolized and produces ketones for a ketogenic diet which is helpful for epilepsy and Alzheimer's. Lauric acid containing triglycerides are also metabolized to the monoglyceride form monolaurin which has antibiotic and antiviral activity. A search on PubMed yields 135 papers on monolaurin.
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Re: Progressive MS treatment phase III study update

Postby Anonymoose » Sat Apr 18, 2015 4:38 am

I wonder if taking a probiotic with bifidobacteria might enhance results and/or allow for a lower dose. Bifidobacteria produce extra cellular biotin (can't find a good solid source but it's mentioned quite frequently).

Biotin itself also has an effect upon gut flora (again, no great sources). It seems like this Biotin thing MIGHT be yet another approach (joining diets, helminths, fmt) that's effectiveness MIGHT stem from the impact on or amelioration of effects of less than perfect gut flora.
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Re: Progressive MS treatment phase III study update

Postby ton » Sat Apr 18, 2015 5:46 am

Wait and see ... (and keep our fingers crossed once again)
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Re: Progressive MS treatment phase III study update

Postby tzootsi » Sat Apr 18, 2015 6:12 am

Anonymoose wrote:I wonder if taking a probiotic with bifidobacteria might enhance results and/or allow for a lower dose. Bifidobacteria produce extra cellular biotin (can't find a good solid source but it's mentioned quite frequently).

Biotin itself also has an effect upon gut flora (again, no great sources). It seems like this Biotin thing MIGHT be yet another approach (joining diets, helminths, fmt) that's effectiveness MIGHT stem from the impact on or amelioration of effects of less than perfect gut flora.


Almond milk yogurt (dairy free) made by Almond Dream, contains bifidobacteria
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Re: Progressive MS treatment phase III study update

Postby 1eye » Sun Apr 19, 2015 7:58 am

Objectives

The aim of this pilot study is to assess the clinical efficacy and safety of high doses of biotin in patients suffering from progressive MS.
Study design

Uncontrolled, non-blinded proof of concept study
Methods

23 consecutive patients with primary and secondary progressive MS originated from three different French MS reference centers were treated with high doses of biotin (100–300 mg/day) from 2 to 36 months (mean=9.2 months). Judgement criteria varied according to clinical presentations and included quantitative and qualitative measures.
Results

In four patients with prominent visual impairment related to optic nerve injury, visual acuity improved significantly. Visual evoked potentials in two patients exhibited progressive reappearance of P100 waves, with normalization of latencies in one case. Proton magnetic resonance spectroscopy (H-MRS) in one case showed a progressive normalization of the Choline/Creatine ratio. One patient with left homonymous hemianopia kept on improving from 2 to 16 months following treatment׳s onset. Sixteen patients out of 18 (89%) with prominent spinal cord involvement were considered as improved as confirmed by blinded review of videotaped clinical examination in 9 cases. In all cases improvement was delayed from 2 to 8 months following treatment׳s onset.
Conclusions

These preliminary data suggest that high doses of biotin might have an impact on disability and progression in progressive MS. Two double-blind placebo-controlled trials are on going.



That was the first, proof-of-concept, trial with 23 patients.

The 2 trials with larger numbers of patients have yet to report, I think.

This is a list of topic, paper, and session titles drawn from the website:

2O15 AAN Annual Meeting Scientific Abstract Listing and Meeting Information

Status Epilepticus
Small Fiber Neuropathies: Sensory, Autonomic, and Both
Deep Brain Stimulation Management
Neuromyelitis Optica: Scientific and Clinical Update
Resident Basic Science I: Neuropathology
The Practice of Neurology: Issues in Coding and Reimbursement
Current Management of Incidental and Asymptomatic Cerebrovascular Lesions
New Windows into the Brain: Technological Advances in Frontline Neurologic Diagnosis via the Visual and Oculomotor Systems
Clerkship and Program Directors Conference
Research Career Development Symposium:
How to Be Successful in Academic Neuroscience
Critical Care EEG Monitoring
Neuromuscular Junction Disorders
Neurologic Complications of Medical Disease
Resident Basic Science II: Neuroanatomy
Advanced Neurologic Coding
Severe TBI: From ICU to Rehabilitation
Pitfalls and Pearls: Avoiding Common Diagnostic Errors in Neuro-ophthalmology and Neuro-otology
Management of Asymptomatic Cerebrovascular Lesions
Webs, Apps, and Social Media: There’s an AAN Tool for That!
The Neurology of Social Behavior
Therapy of Movement Disorders:
A Case-based Approach
Mitochondrial Disorders in Neurology
Canalith Repositioning for Benign Paroxysmal Positional Vertigo
Challenging Headache Cases
AUPN Clerkship Directors Workshop
Neuro Flash: Epilepsy
Neuro-oncologic Emergencies
Balance and Gait Disorders
Cognitive Psychology of Neurologic Errors: Chalk Talk
Creating Innovative, Interactive Teaching Modules
Controversies in Neuroethics
Controversies in Multiple Sclerosis Therapy
Clinical Research: Introduction and Methods
Infectious, Paraneoplastic, Autoimmune?
Diagnosis and Treatment of Rapidly Progressive Encephalopathies
Primer of Behavioral Neurology
Resident Basic Science III: Neuropharmacology
Sports Concussion and Other Mild Concussive Injuries
Teleneurology and Technologies
Hot Topics in Sleep Neurology
Child Neurology I
Dopamine-mediated Neural Plasticity in Motor and Non-motor Circuits
Clinical Epilepsy
Peripheral Neuropathy
Neurology Update I
Genetics in Neurology
Opioids and Marijuana in Your Practice
The Business of Neurology
Leadership for Women (must apply)
You Make the Call—an Interactive, Multimedia,
Case-based Approach to Learning EMG
Therapy of Stroke
Neurology Jeopardy: Things You May Not Know About Publishing in the Journal or Its Spin-offs


Not much I can see there on Biotin, but there are going to be "poster sessions", so maybe it's in one of those. I guess we'll hear about it soon enough.
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