First of all, "Happy New Year" to all the folks in this group.

Do you happen to know which is the active ingredient found in First
Aid antiseptics?

I had a feeling that actually, using such antiseptics can
have a great impact on the herpes viruses prior to your related post
here.

I've used at least one of such antiseptics, such as
"Healing Antiseptic Mecca Ointment"

Mecca , contains:

Zinc Oxide, Petrolatum, Propylene Glycol, BHA, Propyl Gallate,
MEthilparaben, Lanolin, Camphor, Phenol, Propylparaben and others
(fragrance, vegetable shortening).

Besides the other treatments I've been using in the past year,
whatever it worked, it seems that it worked , since
right now I can eat, drink, stay in cold, sun, wind,
getting tired etc etc without having any signs of
herpes activity, which in the past over 2 years this had been
impossible.

It's true that I have a fairly good sleep over nights so that I did
not expose
myself to such a MAJOR stress factor over the immune system, so that I
cannot yet
affirm that I become immune to herpes under all circumstances.

Perl Molson.

----- Original Message -----
From: "M.L.S." <msoja9@newsguy.com>
Newsgroups: alt.support.herpes
Sent: Thursday, January 08, 2004 11:12 AM
Subject: Re: Cold Sores HEALED in 3.6 Days!

You've meant 'Benzalkonium Chloride'?

http://www.google.com/search?num=100&hl=en&lr=&ie=UTF-8&oe=UTF-8&newwindow=1&saf
e=off&q=%22Benzalkonium+Chloride%22+herpes

P.S. I have applied also neem oil it might be one of the
"curing" factors together with the others.

Perl Molson

Introduces
Viroxyn
Executive Summary
The Need For An Effective Treatment – General Discussion
The herpes simplex virus (HSV) affects 90% of the world's population
of six billion. While there are likely
numerous variants, eight (8) are known to infect man. Of these, three
are the best known and thus are of the
most concern to many. HSV-1 is usually associated with Herpes Labialis
(cold sores). HSV-2 is usually
associated with Herpes Genitalis (genital herpes), but HSV-1 has
recently been seen as having a greater
role in genital herpes due to oral sexual behaviors. Accidental
self-inoculation of the eyes after touching a
herpes lesion can lead to Herpes Keratitis (ocular herpes); a leading
cause of blindness. Dental and other
healthcare professionals who treat oral pathologies correctly fear
Herpes Whitlow (infection of the fingers
after working without gloves in an infected mouth). Wrestlers and
other sports enthusiasts who engage in
physical contact sports need to be aware of Herpes Gladiatorum (virus
passed to another via intense
physical contact with an infected person, site, or surface). Herpes
Zoster Virus (VZV) is causal in
chickenpox and in some people returns as Herpes Zoster (shingles). All
three of these virus forms infect
man via a cycle of reactivation events in the nervous system.
The less known blood-borne herpes viruses include EBV, CMV, HSV-6 and
HSV-7, HSV-8. HSV-8 is
associated with Kaposi's Sarcoma (often associated with the onset of
AIDS). Epstein Barr virus (EBV),
Cytomegalovirus (CMV), HSV-6 and HSV-7 are likewise blood-borne
members of the Herpes family.
(Schleis; Herpes 10:1 2003)
One hundred fifty million people in the United States experience
recurrent lesions from oral herpes (usually
HSV-1), commonly known as cold sores or fever blisters. There are
approximately 338 million treatable
outbreaks of these cold sore lesions annually in the United States. A
more serious form of this infection is
manifest as genital herpes (HSV-1 or HSV-2), with sixty-eight million
people suffering from this ailment
and over 612 million treatable outbreaks annually in the United
States.
Genital herpes lesions increase the risk of AIDS transmission of HIV.
During the 42nd Annual Inter-Science
Conference on Antimicrobial Agents and Chemotherapy (Sept. 2002),
researchers reported a more solid
connection. The following is taken from that report: "That HSV-2
directly and substantially increases the
risk of HIV infection in persons exposed to HIV is now both
epidemiologically unassailable and
biologically plausible. The association has been solidly documented in
numerous heterosexual populations
worldwide and increasingly now in MSM (men who have sex with men) in
industrialized nations. In Dr.
Celum's study and all others, the risk of HIV has been directly
related to the presence of serologically
diagnosed HSV infection, regardless of ano-genital ulceration." (43rd
ICAAC, Sept 2002)
There is a need for a remedy to reduce the spread of herpes and
eliminate the pain and human suffering of
those afflicted by the virus. Currently, there is no cure for herpes,
but there are treatments, both legal and
"home brew". Acyclovir (and "sons of Acyclovir") act to interfere with
viral reproduction by offering the
virus a defective DNA building block. Acyclovir and its pro-drugs are
all FDA Approved Rx therapies. In
some, particularly the immune compromised, there can be mutation of
the Herpes virus to become
Acyclovir resistant. (Product Information, 2003 PDR) Abreva is the
only (non-monographic) FDA
approved OTC. It acts in a manner that is similar to a skin protectant
in that it coats cells with a fatty
substance to prevent movement of the virus. (Abreva Drug Approval).
There are also numerous legally
marketed skin protectants (Blistex, Carmex) and topical analgesic
products which act to provide temporary
anesthetic effect to the lesion area. These are marketed under their
respective Tentative Final Monographs.
Finally, there are a host of non-approved remedies (lysine, colloidal
silver, electric shock devices, etc.)
tried by many to escape the pain and suffering that attends recurrent
herpes presentations.
Quadex Sees A Way To Help
Mr. Johnson (CEO and founder of Quadex® Pharmaceuticals, LLC)
developed Viroxyn, a drug intended
for the treatment of cutaneous presentations of HSV, after more than a
decade of research. Following the
discovery and patenting of this innovative treatment approach, Mr.
Johnson formed a Company to
investigate the full potential of the technology and pursue FDA
approval of the drug for the treatment of
several herpes infection diseases.
The discovery made by Mr. Johnson is very significant in that it is an
entirely novel and previously untried
approach to treating cutaneous herpes lesions (herpes is a DNA lipid
coated virus). The current anti-viral
"standard of care" involves using nucleoside analogs to interfere with
the reproductive cycle of the herpes
virus. Viroxyn would not properly be classified as an anti-viral, but
rather a germicidal drug. Based on
textbook references citing in-vitro testing, we believe the method of
action involves the active ingredient
acting to disrupt the lipid coat of the drug and in doing so "kill"
the virus.
The Company was organized to perform research and development and
commercialization of proprietary
technologies through possible strategic partnerships with major
pharmaceutical companies. To assist in this
endeavor, the Company believes it has assembled one of the best teams
of advisors and consultants in the
country. These advisors and consultants specialize in the areas of
regulatory approvals, clinical studies and
leading research in the herpes virus and the related fields. The team
includes individuals that currently hold
or have held the following positions and titles:
· Food and Drug Administration (FDA) and Associations:
- Commissioner of the FDA;
- Director, Institute of International Health;
- Director, Institute of Human Values in Medical Ethics;
- FDA Associate Chief Counsel for Biologics, Associate Chief Counsel
for Foods and
Associate Chief Counsel for Enforcement
- Executive Assistant to the Commissioner of the FDA;
- Various Medical Officer positions at the FDA/NIH; and Supervisor of
statisticians at
the FDA in the Division of Biometrics.
· Research and University Positions:
- Clinical Professor of Medicine and Pharmacology at Pennsylvania
State University
College of Medicine; Chairman, Department of Biomedical Sciences at
New York
Medical College;
- Advising/managing pre-clinical discovery, regulatory affairs and
research and
development projects for firms such as: SmithKline Beecham
Pharmaceuticals/GlaxoSmithKline, Escalon Ophthalmics, Inc./Escalon
Medical
Corp., West Pharmaceutical Services, Inc. and Drug Delivery Group
Pfizer, Inc.
- Assistant Professor of Immunology and Virology at Tulane University
School of
Medicine, Department of Microbiology and Immunology.
- Senior Director of Toxicology at RW Johnson Pharmaceuticals.
- Director of Regulatory Affairs at TRIAD Pharmaceuticals.
- Director, Worldwide Infectious Diseases Clinical Research, Vice
President, Glaxo
Research Institute Resources Administration Vice President, Medical
Affairs,
Director of Clinical Development, Clinical Professor, University of
North Carolina
School of Medicine
Legal Basis for Marketing Viroxyn For The Treatment of Cold Sores /
Fever Blisters
After many years of internal developmental testing, a finished product
form was selected and a pilot
product was produced. This product was informally tested using a base
of interested cold sore sufferers and
interested dermatologists and dentists. Based on the results obtained,
the company began marketing
exclusively within the dental healthcare community under the basis of
an OTC monograph. The case
histories of patients treated by their dentists added to the
confidence that ViroxynÒ had the potential to
have a significant impact on the suffering of many.
In late 2000, there was confusing, and later conflicting information
from FDA as to whether we might need
an Approved New Drug Application (NDA) to market Viroxyn. Taking the
most conservative approach,
the firm decided to proceed using the NDA route. Thus, relying on a
history that included 125,000 patient
doses, and armed with knowledge of the pharmacology of the drug, the
firm began its efforts to bring the
technology to its full potential by applying for an Investigational
New Drug (IND) Application to test the
safety and efficacy of Viroxyn in treating cold sores (Herpes
Labialis). After running a Pilot Trial and
Phase II Trial, the Company learned from local FDA Officials that it
could legally market Viroxyn for the
treatment of cold sores under an OTC Tentative Final Monograph. Using
the results from the clinical
testing to date as justification, the Company has begun manufacturing
and marketing the product for the
treatment of Herpes Labialis under that monograph. The labeling of
Viroxyn is only for the treatment of
cold sores / fever blisters.
The Product
The Company is extremely excited to be at the vanguard of a new
approach to the treatment of herpes.
Little true progress has been made since the introduction of Acyclovir
in 1980. There have been
innovations in getting Acyclovir serum levels higher and finding more
efficient ways to get Acyclovir
technology into the blood stream, but no new innovations beyond that.
Now comes Quadex - offering something new and novel in the treatment
of cutaneous herpes infections.
The demonstrated and reported efficacy of Viroxyn is believed to be
the result of the novelty of the
approach to treatment. An efficient germic idal, such as the active
ingredient in Viroxyn, is rubbed into the
lesion and is assisted by a combination of mechanical action (rubbing)
and the solvent excipient ingredient
in getting the active drug past the barrier of fatty, skin tissues and
into proximity with the infected cells.
The active ingredient then kills all virus it contacts by direct
disruption of the viral lipid coat. (Block, 5th ed,
2001)
It is a rare situation whe
a new drug candidate has information and
treatment experience from a 125,000
dose patient base even before proceeding to clinical trial. While the
data collected during this experience
are fairly categorized as anecdotal, it cannot be ignored. In order to
confirm the Company's preliminary
findings from the initial marketing camp aign, the Company conducted
an independent pilot study of
Viroxyn® . This study had "per protocol" results quite similar to the
anecdotal experience from the
125,000 dose patient base. (See History of Clinical Development) The
results and benefits of Viroxyn® are
well understood and the Company knows of no drug in clinical trials or
approved by the FDA that can
claim similar results. Some of the benefits reported to the Company by
users of the drug include:
•User reports that Viroxyn® is immediately effective; it can be used
at any stage of the infection.
•User reports that when the sore is in full-ruptured weeping stage,
the product stops the cold sore's progress
in a matter of minutes.
•User reports of reduction/elimination of pain caused by the HSV virus
within 10 to 30 minutes.
The user reports listed above come from a collection of anecdotes and
dentist supplied patient case
histories. There can be no assurance, however, that these findings
will be replicated in future well
controlled human clinical trials, but the Company is optimistic based
on the results of clinical studies
conducted to date.
When it submits an NDA for treatment of cutaneous presentation of
genital herpes and shingles, or
additional NDA supplements for treatment of herpes lesions on the
genital mucosa, the Company
anticipates being granted priority review with the FDA. The Company
meets all four of the priority review
status requirements. The FDA is allowed 180 days, which can be
extended by mutual agreement between
the FDA and an applicant, to review an NDA. Priority review reduces
the maximum review period to 90
days.
History of Clinical Development
Following the development of a product and packaging design that would
be ideally suited to human use,
the Company continued its efforts with a literature search to learn if
work done by others might lend
support to this new approach to treating herpes lesions. It was found
that Benzalkonium chloride, the active
ingredient in ViroxynÒ, has demonstrated in vitro germicidal efficacy
against HSV-1 and HSV-2
(Kawanda, et al., 1997; also Belec, et al., 2000). Additionally,
benzalkonium chloride has been shown to
have germicidal activity within 1 minute against HSV-1 in the presence
of whole human blood (Wood and
Payne, 1998).
In addition to patient case reports from dentists and numerous
testimonials received by the firm from
individuals who desired to use the drug on themselves during the
development process, an open label
human pilot study was conducted under IRB supervision. In this study,
use of Viroxyn was compared to the
average natural history literature value of 10 days to healing
(Essman, 2000). Patient population (n=41)
consisted of a mix of naturally occurring cold sores (44%) and UV
induced cold sores (56%). The clinical
study (QL01-1-01) was conducted at an independent study site by a
Board Certified Dermatologist. Both
study arms had similar demographics. The endpoint for healing was loss
of scab and return to intact skin.
Using this endpoint, the Intent To Treat (ITT) population for both
groups showed a mean time to healing of
5.4 days (median = 4.4 days) versus the literature value of 10 days
(S.D. = 2.6 days). The ITT population
included all patients who developed disease and were issued drug
whether or not they treated their lesions
with study drug or were later withdrawn for protocol violations (eg:
using prohibited medications) or who
were lost to follow-up. (Patients lost to follow-up and patients who
were withdrawn were handled as "last
observation carried forward" to the maximum literature value of 10
days. Patients who developed second
cold sores or who experienced secondary lesions, but who did not treat
with study drug were followed to
complete healing of all lesions and the total time to healing was used
in the ITT analysis.)
A "per protocol" analysis was also done. Patients who were lost to
follow-up, who were withdrawn, or who
experienced second cold sores or secondary events and did not treat
with study drug were excluded from
the this analysis. When the "per protocol" analysis was done the
combined groups showed a mean time to
healing of 3.6 days (median = 3.4 days) versus the literature value of
10 days. (S.D. = 1.1 days)
This is significant to the oral herpes sufferer in that medications
already approved by FDA have only been
shown to improve time to healing by approximately one day when
compared to the placebos in the studies.
The pilot study provided a basis for filing an IND and proceeding with
Phase II human clinical trials. A
Phase II human clinical study was begun in summer of 2002. The
clinical portion of the Phase II trial for
Viroxyn (oral herpes indications) was completed on March 11,2003. The
trial design was for the enrollment
of 180 patients and randomized blinded treatment of 120 patients.
Analysis of the data is not yet complete
and a final report is not yet available.
In preparation for submitting a New Drug Application to FDA, the
company's technical team is working
feverishly on a scientifically sound protocol to test the safety and
efficacy of this new and innovative
technology on cutaneous Herpes Genitalis lesions. Future trials will
also test the drug to obtain FDA
approval for label indications allowing the treatment of genital
herpes that present on the genital mucosa.
These efforts will be followed up with work to test a variant of the
drug on cutaneous lesions caused by
Herpes Zoster (shingles). The Company is also considering the
development of a variant that may be used
to treat Ocular Herpes.
Safety
The active ingredient in Viroxyn is considred "GRASE" (Generally
Recognized as Safe and Effective)
when used for the treatment of open cuts, scrapes, and minor burns.
The active ingredient is commonly
found in First Aid Antiseptics and the active ingredient is very
commonly used as a preservative. Viroxyn
is topically applied and not expected to be systemically absorbed. The
adverse events reported during each
of the studies conducted to date were the typical human ailments
including colds, flu, menstrual cramping,
and the like. These occurred roughly evenly in both study groups. One
patient in the pilot study had a root
canal during the study follow period. Another had hives. Still another
experienced a more severe cold sore
than is normal for him following UV irradiation. The Investigators
determined that no adverse events were
related to use of the study drug. There were no deaths or SAE events
in either study.
Market
The Company focuses on research and development of herpes-treatment
products and the aggressive
commercialization of those products through strategic partnerships
with major pharmaceutical companies.
The Company has outsourced manufacturing and packaging to an ISO 9002
and FDA-Registered facility.
Snoeck & De Clercq report that 40% of the population (109 million) are
affected by recurrent cold sores.
Wald (Univ. of Washington) is now reporting that 25% of Americans over
the age of 12 (68 million) are
affected by genital herpes. The National Institutes of Allergy and
Infectious Disease estimates that 90% of
the U.S. population has been exposed to some form of Herpes.
Potential Market by Segment
112,560,000 people with cold sores in the U.S.
2,369,000,000 total people with cold sores internationally
68,000,000 people with genital herpes in the U.S.
1,155,000,000 total people with genital herpes internationally
1,000,000 new cases of herpes zoster in the U.S.
50,000 new cases of ocular herpes in the U.S.
Other
Target Market
Condition
Region
# of People With
Outbreaks
# of Outbreaks
Per Year
Potential Revenue
Cold Sores United States 112,560,000 337,680,000 $2.7 billion
International* 236,900,000 710,700,000 $5.7 billion
Genital United States 68,000,000 612,000,000 $12.2 billion
International* 115,500,000 1,039,500,000 $20.8 billion
Shingles United States 1,000,000 1,000,000 $50.0 million
International* 1,051,730 1,051,730 $52.6 million
* The target market for International has been reduced to 10% of
International potential.
DrugFacts .
Active ingredient Purposes
Benzalkonium Chloride, 0.13% …………………………………………………..…Cold Sore / Fever
Blister Treatment
Topical Antiseptic
Uses
· to treat cold sores / fever blisters.
· to help guard against infection.
Warnings
· For external use only.
· Flammable, keep away from fire or flame
Do not use
· in the eyes
· over large areas of the body
· if you are allergic to any ingredient in this product.
· more than 3 times per day.
· longer than one week unless directed by a doctor
Stop use and ask a doctor
· if condition persists or worsens
· symptoms persist for more than 7 days.
Ask a doctor
· if used to treat deep or puncture wounds, animal bites, or serious
burns.
· you are pregnant or nursing a baby
When using this product you may feel a brief stinging sensation when
you apply it. The sting should go
away in a short time
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right away. If you
are pregnant or nursing a baby, consult a healthcare professional
prior to use.
Directions – Adults and children over 2 years of age.
· Clean the lip area of any lip preparations, lotions, ointments,
residual beverages, or cosmetics including
lipstick using only warm water and a washcloth.
· Remove the cardboard top from the applicator end and place the
cardboard top onto the glass/plastic vial
end – opposite the brush end of the product.
· Squeeze the cardboard to break open the inner glass vial.
· Saturate the applicator end with solution by holding the brush end
down and squeezing the container
until you can see liquid on the brush applicator.
· For best results, massage the solution into the cold sore by
rubbing. Rub firmly, but take care not to
damage the tissue. The purpose of the rubbing is to deliver the drug
to the infection site. Hold the vial so
the solution flows to the sore.
· To treat most cold sores, usually one treatment is enough. But, if
your symptoms go away and then
return later, apply another dose.
· Discard after use.
· Children under 2 years of age – ask a doctor.
Other information Store at room temperature. The ingredients in
toothpaste, soft drinks, and some fruit
juices can de-activate the active ingredient in ViroxynÒ. For best
results, avoid brushing your teeth with toothpaste or
drinking soft drinks or fruit juices for one hour after applying the
drug.
Inactive ingredients Isopropyl alcohol , water. .
Questions: 1-877-825-7153

http://viroxyndirect.com/ExecutiveSummary.pdf

----- Original Message -----
From: "M.L.S." <msoja9@newsguy.com>
Newsgroups: alt.support.herpes
Sent: Thursday, January 08, 2004 11:32 AM
Subject: Re: Asymptomatic shedding- symtomatic visually only, possibility?

I did so.

In ginger, I've read that it is more effective used dried,
since its constituents have different properties.
I've read this in "Spontaneous healing" by Andrew Weil.

It can be the same story with the kelp, used dry, in tea.

Perl Molson