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BioHealthonomics

Proprietary Migraine Product

Regulation Crowdfunding
Santa Monica, CA
Pharmaceutical
Accepting International Investment


Histamine exists in all individuals.  Histamine regulates various activities of the brain such as the arousal state, brain energy metabolism, locomotor activity, neuro-endocrine activities, autonomic and vestibular functions, feeding, drinking, sexual behavior and pain.

In people suffering from migraine headaches, the histamine levels are higher than in healthy individuals. This is because these individuals are very sensitive and as soon as a stressor/trigger is introduced (too hot or too cold, a particular food, a particular smell, too much exercise, etc.) the mast cells (main source of histamine) degranulate (break off).  You can think of mast cells as small "eggs" that can break very easily.  The more sensitive a person is, the easier is for these "eggs" (mast cells) to break and release histamine. In susceptible individuals this manifests as a migraine.

BioHealthonomics has developed a technology (modulation of histamine receptors), that over the treatment period, the company believes it makes the shell of the "eggs" stronger and prevents them from prematurely degranulating (i.e. breaking off).

“Histamine can be a wonder drug (or hormone) if used wisely and for a sufficient length of time. In selected cases it can make the lame to walk, the deaf to hear, and the blind to see. I know. I have seen it happen. More "miracles" in my experience have been wrought with histamine than with all other therapeutic procedures combined.” 1979                                                              Dr. Bayard T. Horton, MD, Mayo Clinic (1895-1980)

Migraine Prevention & Results Oriented Healthcare

Invest in BioHealthonomics

BioHealthonomics is a pharmaceutical company developing a proprietary, industry unique technology (histamine dihydrochloride) for the treatment and prevention of migraine headaches (lead indication) and other CNS indications.


The National Headache Foundation estimates that US businesses lose $50 billion each year because of medical expenses caused by headaches, reduced employee productivity, and absenteeism.


It is the 6th most disabling disorder in the US, and more than 30 million people suffer from migraines.


The company developed an industry unique solution that addresses the root cause of the problem. The technology targets histamine receptors involved in migraine headaches. The proof for the effectiveness of the approach starts with the work of Dr. Bayard Horton of Mayo Clinic who successfully treated 1,402 patients in the 1950’s. Furthermore, the successful clinical trials conducted in Mexico over the past 25 years are additional proof of the validity and effectiveness of the proposed approach.


Up to date, the company has two issued patents in the U.S. and is patent pending in five other global markets.


We believe our technology is superior to the CGRP antibodies approach from a safety, efficacy and cost standpoints. Recent exits of companies developing CGRP antibodies for migraines: 

1. Labrys Biologics was acquired by Teva Pharmaceuticals for $825M after the completion of their Phase II clinical trial.

2. Alder BioPharmaceuticals issued an IPO upon completion of their Phase II clinical trial. Current market cap is $800M. Market cap peaked at $3.5B in July 2015.


BioHealthonomics will start its development with Phase II clinical trial.


Based on clinical studies up to date, the CGRP antibodies approach works in approximately 50% of migraine patients while our HISTAMINE receptor modulation approach works in over 80% of migraine patients.


The company has a clear path in developing an extremely effective, side effects free migraine treatment that offers unprecedented value to migraine patients.


Join us in bringing this unique technology to market!

Investment
$50/share of common stock│When you invest you are betting the company’s future value will exceed $27.6M.


Perks

$5,000+ One month treatment once FDA approval is obtained

$10,000+ Three month treatment once FDA approval is obtained

$15,000+ Six month treatment once FDA approval is obtained

*All perks occur after the offering is completed.

What We've Accomplished So Far

•   Filed Investigational New Drug application (IND 115,375) for migraine headaches with the FDA.

•   U.S. Patent No. 9023881 issued in May 2015 (Patent title: Methods for Restoration of Histamine Balance) 

•   U.S. Patent No. 9511054 issued in December 2016

•   National Phase PCT applications in following countries / region:

            Europe, Japan, Brazil, India, Canada

•   BioHealthonomics entered into a strategic agreement with another pharmaceutical company to gain access to pre-clinical, phase I clinical and Chemistry, Manufacturing and Controls data, saving millions of dollars in development cost and years in development time.

•   Although BioHealthonomics is using the same product as EpiCept (Histamine Dihydrochloride), the company has its stand alone IP that is completely different from EpiCept’s IP.

Product: Histamine Dihydrochloride

During symptom free states (i.e. no migraine), histamine levels are higher in people suffering from migraines than in healthy individuals.

Histamine exists in all individuals.  In people suffering from migraine headaches, the histamine levels are higher than in healthy individuals.  This is because these individuals are very sensitive and as soon as a stressor/trigger is introduced (too hot or too cold, a particular food, a particular smell, too much exercise, etc.) the mast cells (main source of histamine) degranulate.  You can think of mast cells as small "eggs" that can break very easily.  The more sensitive a person is, the easier is for these "eggs" (mast cells) to break.

Based on up to date clinical trial data, CGRP antibodies have an approximately 50% response rate for Episodic Migraine patients

During a migraine event, the histamine level in a person suffering from migraines is up to 3 times higher than the histamine level in a healthy person.

A person suffering from migraines has higher than normal histamine levels. Once a stressor/trigger is introduced, more and more "eggs" containing histamine (i.e. mast cells) degranulate further increasing the histamine levels.  As a result, the person experiences pain.  

BioHealthonomics developed a technology (modulation of histamine receptors), that over the treatment period, makes the shell of the "eggs" stronger and prevents them from prematurely degranulating (i.e. breaking off).

Based on up to date clinical trial data, CGRP antibodies have an approximately 50% response rate for Chronic Migraine patients

What Makes BioHealthonomics Different 

Industry-unique solution that addresses the root cause of the problem.
 Two issued patents in the U.S. and patent pending in 5 additional markets.


 CGRP antibodies are not addressing root cause.
      CGRP approach: approx. 50% patient response rate
      Histamine receptor modulation approach: over 80% patient response rate (R.O. Millan-Guerrero, European Journal of Neurology 2007, 14: 1079-1084)


 We believe BioHealthonomics’ technology is more powerful than the CGRP antibodies approach at all levels:
      Safety
      Efficacy
      Cost



Over the years there have been a number of clinical trials highlighting the efficacy of histamine in migraine patients. Formal and informal clinical trials have taken place in the U.S., Mexico and Europe with over 4,000 patients being exposed to histamine. 

A correlation between migraine, histamine and immunoglobulin E.

Gazerani P1, Pourpak Z, Ahmadiani A, Hemmati A, Kazemnejad A.

Abstract

Although migraine affects about 15% of population and many studies have been performed to find the mechanism and a successful management, the physiopathology of migraine is still largely unknown. The possibility of an immunoglobulin E (IgE)-mediated allergic mechanism and the role of histamine remain controversial. The aim of the present study was to evaluate serum total IgE and histamine levels in migraine patients and the influence of allergy on them. Seventy patients (18-58 years) with migraine without aura were divided into two groups according to their history of allergy (60% with and 40% without allergy). Serum samples were collected during fasting without allowing any premedication during the two periods of attack and remission. There was a control group containing 45 healthy volunteers. Serum total IgE and histamine levels were measured by enzyme-linked immunosorbent assay and fluorimetric methods, respectively. Mean and standard errors of serum histamine (ng/ml) and total IgE (IU/ml) levels were found in the control group to be 48.16 +/- 2.70 and 38.31 +/- 3.20, in the migraine with allergy group 159.11 +/- 4.60 and 303.30 +/- 42.50 and in the migraine without allergy group 105.01 +/- 8.50 and 79.07 +/- 2.70, respectively. Total IgE levels in migraine with allergy group were found to be significantly (P < 0.0001) above that in the control and another group, suggesting an influence of an IgE-mediated mechanism on migraine. Although the plasma histamine levels, which were significantly elevated (P < 0.0001) in patients with migraine, both during headache and symptom-free periods, when compared with the control group, indicate that there is an increased susceptibility to histamine in allergic conditions, this molecule has also an unrelated role in migraine. The relationship between allergy and migraine can be based, in part, on an IgE-mediated mechanism, and histamine release plays an important role. Thus, the avoidance of allergic conditions in migraine patients may be a simple, helpful way for prophylaxis or their treatment.

Subcutaneous histamine versus botulinum toxin type A in migraine prophylaxis: a randomized, double-blind study

Millán-Guerrero RO1, Isais-Millán S, Barreto-Vizcaíno S, Rivera-Castaño L, Rios-Madariaga C.

OBJECTIVES:

To compare the efficacy and tolerability of the subcutaneous administration of histamine and botulinum toxin type A (BoNTA) in migraine prophylaxis.

BACKGROUND:

Histamine has a selective affinity for H3 receptors and it may specifically inhibit the neurogenic edema response involved in migraine pathophysiology.

METHODS:

One hundred patients with migraine were selected in a 12-week double-blind controlled clinical trial to evaluate the efficacy of subcutaneous administration of histamine (1-10 ng twice a week) n = 50, compared with administration of 50 U of BoNTA (one injection cycle) n = 50.

CONCLUSIONS:

This randomized study demonstrated that both histamine and BoNTA are similarly effective and well tolerated in reducing or eliminating headache in migraine prophylaxis. Low doses of histamine applied subcutaneously may represent a novel and effective therapeutic alternative in migraine patients and lay the clinical and pharmacological groundwork for the use of H3 agonist in migraine prophylaxis.

Histamine as a therapeutic alternative in migraine prophylaxis: a randomized, placebo-controlled, double-blind study.

Guerrero RO1, Cárdenas MA, Ocampo AA, Pacheco MF.

Abstract

This study was undertaken to test the efficacy of the subcutaneous administration (twice a week) of consecutively increasing doses of histamine (0.1 to 1 ng) in the prophylaxis of migraine, compared to placebo, under a controlled, double-blind, clinical trial for 12 weeks. Sixty patients were selected, under criteria established by the International Headache Society (both sexes, 18 to 65 years of age, a migraine history of more than 1 year, one to six headache attacks per month), having no additional neurological or cardiovascular pathologies, and after a complete clinical and laboratory examination including computer-assisted tomography. Comparison between the groups treated with placebo (n = 30) and histamine (n = 30), on data collected for the 4th, 8th, and 12th weeks of treatment, revealed that histamine exerted a significantly (P < .0001) greater reduction (compared to placebo) in the frequency, intensity, and duration of migraine attacks, as well as on the use of rescue medication. No significant (P > .05) adverse experiences or side effects in either group developed to impede the blinding of the study or the planned order of events. We conclude that the subcutaneous administration of histamine (at very low doses) constitutes a novel and effective therapeutic approach in migraine prophylaxis, aimed at limiting excessive inflammatory responses involved in the pathophysiology of migraine through the activation of H3 receptors.

Subcutaneous histamine versus topiramate in migraine prophylaxis: a double-blind study.

Millán-Guerrero RO1, Isais-Millán R, Barreto-Vizcaíno S, Gutiérrez I, Rivera-Castaño L, Trujillo-Hernández B, Baltazar LM.

BACKGROUND:

Histamine has a selective affinity for H3 receptors and it may specifically inhibit the neurogenic edema response involved in migraine pathophysiology.

OBJECTIVE:

To evaluate the therapeutic potential of subcutaneous administration of histamine in migraine prophylaxis, compared with oral administration of topiramate.

METHODS:

Ninety patients with migraine were selected in a 12-week double-blind controlled clinical trial to evaluate the efficacy of subcutaneous administration of histamine (1-10 ng twice a week) compared with oral administration of topiramate (100 mg daily dose). The variables studied were: headache intensity, frequency, duration, analgesic intake and Migraine Disability Assessment.

RESULTS:

The data collected during the 12 weeks of treatment revealed that headache symptoms improved in both the histamine and topiramate groups, which was evident within the first month after the initiation of treatment, with statistically significant (p < 0.001) reductions in headache frequency (50%), Migraine Disability Assessment score (75%), intensity of pain (51%), duration of migraine attacks (45%), as well as in the use of rescue medication (52%).

CONCLUSION:

The present study provides evidence of the efficacy of subcutaneously applied histamine and orally administered topiramate in migraine prophylaxis. Subcutaneously applied histamine may represent a novel and effective therapeutic alternative in resistant migrainepatients.

(c) 2008 S. Karger AG, Basel.

Our Market and Industry

The National Headache Foundation estimates that US businesses lose $50 billion each year because of absenteeism, reduced employee productivity, and medical expenses caused by headaches. (JD Bartleson, Treatment of Migraine Headaches, Mayo Clin. Proc. 1999; 74; 702-708). In the U.S., more than 30 million people suffer from migraines, according to a 2001 report from the Health’s National Institute of Neurological Disorders and Stroke. It is the 6th most disabling disorder in the US. Neurologists agree that safer and more effective prophylactic agents represent the most critical unmet need in the treatment of both episodic and chronic migraine (Decision Resources). With its unique approach to migraine management, BioHealthonomics plans to become the market leader in the migraine arena and offer the migraine patients an unprecedented value proposition.

Significant Market Finding

Despite a recognized unmet need for better tolerated, side effects free and more efficient prophylactic treatment for episodic and chronic migraines, few preventive drugs are currently available or in the future pipeline. As a result, we believe the migraine prophylaxis (preventive) drug market will remain small and underserved. (Source: Decision Resources)


CGRP antibodies are currently under development by a number of companies: AMGEN, Teva Pharmaceuticals, Alder BioPharmaceuticals and Lilly and Co..

Based on clinical studies up to date, the CGRP antibodies approach works in approximately 50% of migraine patients while our HISTAMINE receptor modulation approach works in over 80% of migraine patients.


The current migraine product market is $3.4B and is projected to grow up to $10B in the next decade.


Based on clinical data up to date, we believe BioHealthonomics' technology is superior to the CGRP antibodies approach from a safety, efficacy and cost stand points. Recent exits of companies developing CGRP antibodies for migraines:

1. Labrys Biologics was acquired by Teva Pharmaceuticals for $825M after the completion of their Phase II clincal trial. 

2. Alder BioPharmaceuticals issued IPO upon completion of their Phase II clinical trial.  Current market cap is $800M. Market cap peaked at $3.5B in July 2015.   

.

Offering Summary

Maximum 2,140 shares of common stock ($107,000)

Minimum 200 shares of common stock ($10,000)


Company
BioHealthonomics Inc.
 

Corporate Address
810 California Ave, Suite 100, Santa Monica, CA 90403
 

Description of Business
BioHealthonomics Inc. is a clinical stage biotechnology and healthcare company that is developing a proprietary technology for the treatment and prevention of migraine headaches, ALS, Alzheimer’s disease, CTE & other neurological indications.

 

Type of Security Offered
Common Stock
 
Purchase Price of Security Offered
$50


Minimum Investment Amount (per investor) 
$100













Perks

$5,000+ One month treatment once FDA approval is obtained

$10,000+ Three month treatment once FDA approval is obtained

$15,000+ Six month treatment once FDA approval is obtained

*All perks occur after the offering is completed

Irregular Use of Proceeds

The Company might incur Irregular Use of Proceeds that may include but are not limited to the following over $10,000: Any expense labeled "Administration Expenses" that is not strictly for administrative purposes; Any expense labeled "Travel and Entertainment"; Any expense that is for the purposes of inter-company debt or back payments.

Show More
Most recent fiscal year-end:
Prior fiscal year-end:
Total Assets
$200,674.43 USD
$187,927.31 USD
Cash And Cash Equivalents
$7,511.43 USD
$3,260.31 USD
Accounts Receivable
$0.00 USD
$0.00 USD
Short Term Debt
$68,502.13 USD
$60,393.57 USD
Long Term Debt
$35,607.47 USD
$44,407.47 USD
Revenues And Sales
$0.00 USD
$0.00 USD
Costs Of Goods Sold
$0.00 USD
$0.00 USD
Taxes Paid
$818.40 USD
$800.00 USD
Net Income
-$12,161.44 USD
-$8,880.60 USD

Risks

A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment. In making an investment decision, investors must rely on their own examination of the issuer and the terms of the offering, including the merits and risks involved. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. Furthermore, these authorities have not passed upon the accuracy or adequacy of this document. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature. These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.


Updates

Last chance for becoming part of the solution for migraine headaches

over 1 year ago

Our campaign will close tomorrow. Please visit the campaign link below to become an investor and help address the root cause of migraines.

7 days left in the campaign

over 1 year ago

Become part of the solution for migraine headaches.  

Subcutaneous histamine versus sodium valproate in migraine prophylaxis

over 1 year ago

Background

Histamine has a selective affinity for H3-receptors and it may specifically inhibit the neurogenic edema response involved in migraine pathophysiology. The objective of this study was to evaluate the therapeutic potential of subcutaneous administration of histamine in migraine prophylaxis, compared with oral administration of sodium valproate, in an open clinical trial. Ninety-two patients with migraine were selected under criteria established by the International Headache Society and enrolled in a 12-week double-blind controlled clinical trial to evaluate the efficacy of subcutaneous administration of histamine (1-10 ng twice a week; n = 46) compared with oral administration of sodium valproate (500 mg daily dose; n = 46). The variables studied were headache intensity, frequency, duration, analgesic intake and migraine disability assessment (MIDAS).


Results

Eighty-four percent of patients receiving histamine reported an 82% reduction in headache duration P < 0.001 (mean, 39 ± 3 h of headache per attack; whereas 54% of patients receiving sodium valproate reported a 17% reduction (mean, 37 ± 8 h before treatment vs. 20 ± 0.5 h after treatment).


Conclusion

Low concentrations of histamine (1-10 ng) has become a therapeutic alternative in our medical consultations in patients presenting recurrent migraine who do not respond to diverse antimigraine drugs and it is our treatment of choice in migraine patients over 60 years of age who have hypotension or cardiac rhythm alterations, and in whom the usual drugs are contraindicative (p-adrenergic), or in patients having developed secondary gastritis and cannot tolerate further oral drug therapy.


Source: https://www.ncbi.nlm.nih.gov/pubmed/17880560

BioHealthonomics will be at the CED Life Science Conference, FEBRUARY 27 and 28 in RALEIGH, NC

over 1 year ago

BioHealthonomics will be at the CED Life Science Conference, FEBRUARY 27 and 28 2018 at the Convention Center in RALEIGH, NC.

https://cednc.org/company-profile/BioHealthonomicsInc


Equity fund raising offer is progressing well. Help us keep the momentum going

over 1 year ago

The current equity fund raising offers is progressing well with over $30K committed.


Help us keep the momentum going.  


All information can be accessed at the link below.


https://www.startengine.com/biohealthonomics


Prophylactic Activity of Increasing Doses of Intravenous Histamine in Refractory Migraine: Headache Center, Department of Internal Medicine, University of Florence, Italy

over 1 year ago

Background

Histamine is thought to play a pivotal role in the modulation of peripheral and central pain. The administration of increasing doses of histamine may lead to desensitization of receptors of histamine types 1 and 2, causing meningeal vasodilation, and to depletion of neuropeptides in the trigeminal ganglion, thus inhibiting the initiation of migraine.


Objective

In this study, the efficacy and tolerability of increasing doses of IV histamine in migraine prophylaxis were investigated.


Methods

This single-center, open-label, retrospective, controlled study was conducted at the Headache Center (Department of Internal Medicine, University of Florence, Villa Monna Tessa, Italy). Patients included in the study had 3 to 6 migraines without aura per month that were refractory to common symptomatic and prophylactic agents in the 6 months preceding the study. Patients were treated with IV histamine hydrochloride for 21 days starting with a dosage of 0.5 mg/d and increasing to 4.0 mg/d. To assess the efficacy of the treatment, these patients were matched for age; sex; and frequency, duration, and severity of attacks with untreated migraineurs. Clinical benefit was defined as -< 1 migraine of mild intensity per month. Tolerability was assessed during the hospitalization period, and patients were instructed to contact the Headache Center to report any adverse effects after hospital discharge.


Results

The histamine group comprised 47 patients (40 women, 7 men; mean [SD] age, 42.0 [8.6] years) and the control group comprised 23 patients (20 women, 3 men; mean [SD] age, 38.8 [8.4] years). The histamine-treated patients showed a clinical benefit lasting for a mean of 10.4 (4.2) months, while the patients in the control group showed a clinical benefit of 3.8 (1.9) months. The difference in the duration of the clinical benefit between the 2 groups was 6.6 months (95% CI, 5.15-7.99). Adverse effects consisted of flushing, heat sensation during infusion, headache, and palpitations.



Conclusions

In this study, histamine showed lasting prophylactic efficacy in migraineurs. If further research confirms this preliminary finding, histamine could be considered when established prophylactic drugs, such as betablockers, calcium antagonists, antidepressants, and antiepileptics, have not been effective.


Study was conducted by Umberto Pietrini, MD, Massimo De Luca, MD, Enrico Del Bene, MD,  Francesco De Cesaris, MD, Luca Bertinotti, MD,  Nicola Colangelo, MD,  and Alberto Moggi Pignone, MD at the Headache Center, Department of Internal Medicine, University of Florence, Italy


Source: https://www.ncbi.nlm.nih.gov/pubmed/24936105


Notice of Funds Disbursement

over 1 year ago

[The following is an automated notice from the StartEngine team].

Hello!

As you might know, BioHealthonomics has exceeded its minimum funding goal. When a company reaches its minimum on StartEngine, it's about to begin withdrawing funds. If you invested in BioHealthonomics be on the lookout for an email that describes more about the disbursement process.


This campaign will continue to accept investments until its indicated closing date.


Thanks for funding the future.

-StartEngine

The role of mast cells in migraine pathophysiology by Dr. Theoharis C. Theoharides, Tufts University School of Medicine

over 1 year ago

Mast cells are critical players in allergic reactions, but they have also been shown to be important in immunity and recently also in inflammatory diseases, especially asthma. Migraines are episodic, typically unilateral, throbbing headaches that occur more frequently in patients with allergy and asthma implying involvement of meningeal and/or brain mast cells. These mast cells are located perivascularly, in close association with neurons especially in the dura, where they can be activated following trigeminal nerve, as well as cervical or sphenopalatine ganglion stimulation. Neuropeptides such as calcitonin gene-related peptide (CGRP), hemokinin A, neurotensin (NT), pituitary adenylate cyclase activating peptide (PACAP), and substance P (SP) activate mast cells leading to secretion of vasoactive, proinflammatory, and neurosensitizing mediators, thereby contributing to migraine pathogenesis. Brain mast cells can also secrete proinflammatory and vasodilatory molecules such as interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF), selectively in response to corticotropin-releasing hormone (CRH), a mediator of stress which is known to precipitate or exacerbate migraines. A better understanding of brain mast cell activation in migraines would be useful and could lead to several points of prophylactic intervention.

Comment: The reason why CGRP antibodies work only in 50% of migraine patients is because CGRPs are only ONE of the MANY neuropeptides activating mast cell degranulation.


Mast cells could serve both as key "sensor" and "effector" cells in migraines locally in the meninges, as well as in the hypothalamus.


The premise discussed above may offer a more realistic explanation of migraine headaches than the vascular or CSD theories presented so far, and could account for a purely physical (sunstroke), emotional (fear of exam failure), or molecular (oxidative stress) trigger of migraines.


Comment: The proposed mechanism of action is fully in line with the proposed technology that BioHealthonomics is developing and is ready to be evaluated in migraine patients.


Full article can be downloaded here:

http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.717.9472&rep=rep1&type=pdf

 

Status update

over 1 year ago

Happy New Year!

We have reached 25% of our goal. There are 30 days left in the campaign.

Please visit https://www.startengine.com/biohealthonomics



Clinical Study 1945: Dr. Stuyvesant Butler, Professor Emeritus at Northwestern University Medical School: Intravenous histamine in the treatment of migraine

over 1 year ago

In 1945 Dr. Stuyvesant Butler, Professor Emeritus at Northwestern University Medical School and Dr. William Thomas have conducted a study evaluating the use of Histamine in the treatment of migraine headaches.

https://www.ncbi.nlm.nih.gov/pubmed/21016160


The results of the study conducted on 34 patients are summarized below:


"All patients have been observed for at least 6 months since intravenous histamine therapy, 17 from twelve to eighteen months and 8 for more than 18 months."


Summary of histamine-mediated symptoms

over 1 year ago

This image captures the complexity of histamine and the histamine receptors. Note the number of conditions related to histamine and the four (4) histamine receptors (H1R, H2R, H3R, H4R). 

The full article can be read here: http://ajcn.nutrition.org/content/85/5/1185.long


True Believer Bayard Taylor Horton (1895 to 1980) By David Goldblatt, M.D. – excerpts from the article regarding Cluster Headaches

over 1 year ago

When a physician reports an extraordinarily large series of cases, we are impressed by the numbers only when we have satisfied ourselves that the cases have been carefully analyzed.

Over a 20-year span, Bayard Horton studied 1402 patients with histaminic cephalgia-impressive not just for the number, and not only because the cases were meticulously studied (from talking to persons who knew Horton, I feel sure of that) but because histaminic cephalgia was his name for what others soon began to call "Horton's headache" an entity only sporadically reported and never fully delineated or carefully analyzed before Horton's contributions appeared. Horton clearly identified the clinical features of the disorder: the predilection for males; the age of onset, later than with migraine; the lack of family history; the recurrences, all on the same side;

the location near the eye; the lack of accompanying nausea but presence of lacrimation, rhinorrhea, sweating, and increased skin temperature (which Horton measured with surface thermometers); the tenderness of the carotid; the occurrence at night (and following daytime recumbency); the accompanying Horner's syndrome; and, above all, the pain- "steady, excruciating, burning and boring" pain.

Firm in the belief that "Nature heals but histamine cures'' a belief based on his considerable knowledge of pathophysiology, Horton, like a cat following a patch of sunlight, followed histamine for the rest of his long life.

Bayard Taylor Horton was a Virginian. He was born in Gate City, Virginia, on December 6, 1895. He received his undergraduate and medical education at the University of Virginia and began his career by practicing in Emory, Virginia, where he also taught biology at Emory and Henry College.

In 1925, Horton moved to Rochester, Minnesota, took postgraduate training in the Mayo Graduate School of Medicine (University of Minnesota), and, in 1929, was appointed to the staff of the Mayo Clinic. In 1940, he became head of the Section of Clinical Investigation. He lost his laboratory at the end of 1955, became a member of the Emeritus Staff in 1958, and moved to Sun City, Arizona.

Horton's patient and golfing companion, Del Webb, was the founder of Sun City, whose residents Horton admired for their latter-day pioneering spirit.

Horton was instrumental in the founding of the Walter 0. Boswell Memorial Hospital in Sun City, became chairman of the hospital's Committee for Clinical Investigation, created its Proceedings (obviously modeled on the Proceedings of the Staff Meetings of the Mayo Clinic), and continued to supervise the histamine treatment of patients, conducted chiefly by Dr. Dorothy Macy, Jr..

In that "retirement community”, he found many patients with macular degeneration. After an article on his histamine treatment came out in one of the magazines sold at checkout stands, patients began rolling in in their campers to receive histamine treatment. They came from Texas, from Oregon and Washington, and from the Midwest to mobile home sites near the hospital.

The illnesses that Horton tried to cure remain enigmatic, and some at least may ultimately make sense when viewed from his perspective. In the meanwhile it is rewarding to give some thought to a life like his: if most of us, like the poet, have hearts that follow all our days something we cannot name, Horton was different: his "something" had not only a name (histamine) but a chemical structure. He must have found great satisfaction in that.

Latest published patent (Nov. 7 2017): United States Patent No. 9,808,444

over 1 year ago

To get additional details on our latest published patent (November 7, 2017) please follow the link below:

https://tinyurl.com/yddamrqo

SUMMARY 

Dysregulation or imbalances of the histamine system can be a leading contributor to a variety of disease states and symptoms, many of which can be debilitating or life-disruptive. For example, abnormally high histamine levels can lead to excessive allergies (or hyperactive responses to allergens), hyperactivity, compulsive or obsessive behavior, vertigo, inner ear pressure, depression, anxiety, panic attacks, migraine headaches, heightened emotional sensitivity and/or suicidal tendencies. Reduced histamine levels can lead to depressed metabolism and/or weight gain, paranoia, grandiosity, hallucinations (e.g., classic schizophrenic symptoms), tinnitus, hirsutism, visual and auditory abnormalities, anxiety and food sensitivities. The potential costs (both emotional and financial) of histamine imbalance, be they to an individual person or family, related to societal lost productivity and/or burdens on the medical system, are immense. In 2012 America will have spent $200 billion in direct costs for those with Alzheimer's Disease. Caring for people with Alzheimer's Disease is estimated to cost at least $20 trillion over the next 40 years. Furthermore, the economic burden of Parkinson's disease is at least $14.4 billion a year with an estimate that the prevalence of Parkinson's disease will more than double by year 2040. 

General 

Histamine, first identified as an autacoid having vasoactive properties, and also referred to in some contexts as "substance H", is a member of the biogenic amines family and is synthesized from the amino acid histidine by the activity of L-histidine decarboxylase (HDC). Histadine decarboxylase (HDC) is an enzyme that is expressed in various cells throughout the body, including central nervous systems (neurons), gastric-mucosa (parietal cells), mast cells (which can contain .about.3 pg of histamine per cell), and basophils (which can contain .about.1 pg of histamine per cell). Histamine is involved in a variety of different physiological functions, including but not limited to, immune and allegoric responses, endocrine system function and homeostasis as well as cell proliferation, differentiation hematopoiesis, embryonic development, regeneration, wound healing, aminergic neurotransmission, various other brain functions (sleep, nociception, food intake and aggressive behavior), secretion of pituitary hormones, regulation of gastrointestinal and cardiovascular systems, and other various signaling pathways. Histamine has also been correlated with allergies (e.g., drug allergies, hay fever, allergic asthma, etc.). Elevated histamine has also been detected in skin and plasma samples from patients with atopic dermatitis (AD), chronic urticaria (CU), multiple sclerosis (MS) and/or psoriatic skin. In Parkinson's Disease patients, histamine levels have been shown to be increased in specific brain regions, such as the putamen, substantia nigra and external globus pallidus. In Alzheimer's disease, certain histaminergic neurons display degeneration and tangle formation. Also, a decline in histamine levels and/or HDC activity has been associated with Alzheimer's disease and Down's syndrome. 

Headache Currents: Histamine and Migraine by Hsiangkuo Yuan, MD, PhD ; Stephen D. Silberstein, MD

over 1 year ago

Full article can be seen at http://onlinelibrary.wiley.com/doi/10.1111/head.13164/abstract

Background—Histamine is an ancient “tissue amine” preceding
multicellular organisms. In the central nervous system
(CNS), its fibers originate solely from the tuberomammillary
nucleus and travel throughout the brain. It is mainly responsible
for wakefulness, energy homeostasis, and memory consolidation.
Recently, several studies suggest a potential role of
histamine in migraine pathogenesis and management.

Results—Histamine plays a crucial role in migraine pathogenesis:
sustaining the neurogenic inflammation pathway.
Interaction between mast cells (MC) and calcitonin-gene
related protein (CGRP) results in sensitization of trigeminal
afferents and trigeminal ganglia (TG). Histamine binds with
differing affinities to four different histaminergic G-protein
coupled receptors, activating protein kinases, or triggering calcium
release with subsequent mode of actions. Histamine 1
receptor (H1R) and histamine 2 receptor (H2R) antagonists
are frequently used for the treatment of allergy and gastric
acid secretion, respectively, but their antagonism is probably
ineffective for migraine. Histamine 3 receptor (H3R) and histamine
4 receptor (H4R) have a threefold higher affinity than
H1R/H2R for histamine and are found almost exclusively on
neurons and immune tissues, respectively. H3R acts as an
autoreceptor or as a heteroreceptor, lowering the release of histamine
and other neurotransmitters. This is a potential target
for anti-nociception and anti-neurogenic inflammation. To
date, several small clinical trials using low dose histamine or
Na-methylhistamine have demonstrated migraine prophylactic
efficacy, probably via H3R or other undetermined pathways.
Conclusion—The histamine system interacts with multiple
regions in the CNS and may hypothetically modulate the
migraine response. Low dose histamine may be a promising
option for migraine prevention.

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