Item
1.01
|
Entry
into a Material Definitive Agreement
|
Agreement
for Clinical Trials of Laboratory Protocols
On
October 12, 2018 Canna Inno Laboratories Inc. a Canadian corporation (“Canna Inno”)and wholly owned subsidiary of
Earth Science Tech Corporation, a Nevada corporation (the “Company”) entered into an agreement for the clinical study
of the protocols to be used in the processing of samples collected using its MSN-2 collection device, which is used in testing
for / diagnosing
Chlamydia and Gonorrhea (the “Agreement”). The clinical trials will
be conducted by a third-party laboratory, Procrea Fertilité, a division of Procrea Mount Royal, Group Opmedic Inc. (“Procrea”).
The study is the next step in bringing the MSN-2 product to market. Its purpose is validating and fine tuning the protocols that
will be used by laboratories in processing larger numbers of collected samples before launching manufacture, sales and distribution
of the MSN-2 device. Under the Agreement, testing will begin with processing 20 samples (whose results are already known) and
conclude with processing batches of 500 to 1,000 specimens to determine whether Cobas 4800CT/NG technology can be used in processing
samples collected using Earth Science Pharmaceuticals, Inc.’s MSN-2 device as the method of specimen collection. Canna Inno
will pay $3,000, initially, prior to initiation of the clinical trials. We will be responsible for providing the specimens and
will provide the robotic agitator during the duration of the tests, as well as certain other equipment e.g. 50ml conical test
tubes. The fee for testing will be $100 per case for the first 20 cases and then $67 per case for 500 to 1,000 samples. Procrea
will conduct the test using Roch’s Cobas 4800CT/NG equipment and provide a report for each specimen tested. The overall
Agreement is for a one year period and renews automatically for successive one year terms, unless terminated with four weeks’
notice. Although Canna Inno will be billed monthly, it will only be billed for the testing it does; so, if Canna Inno does not
send specimens to Procrea for testing, there is no work to do and therefore no continuing expenses.
Once
testing is successfully completed, Earth Science Pharmaceuticals, Inc. will have the final protocols confirmed for analyzing the
specimens collected with its MSN-2 device and it will be positioned to begin production, distribution and sales.
The Company has secured distribution channels in Viet Nam and Morocco and these are both jurisdictions that allow for self diagnosis.
Currently in the United States, only the state of New Mexico allows for self diagnosis and as such, the primary markets for this
medical device will be in countries outside of the United States, where self diagnosis is legally permissible, until such time
as additional states may allow for it.
The
MSN-2 Device
The
MSN-2 device itself, is a modified panty liner worn by women to allow for the self-collection of a
gynecological
specimen. Currently the device allows human cells to be collected and tested for two types of infections,
Chlamydia
and Gonorrhea. It provides women with the ability to be self-collect specimens in a non-clinical setting, send them to a laboratory
that will process the specimens and notify them if they test positive for either sexually transmitted disease so that they can
seek treatment.
This technology allows the Company to provide diagnostic services to high-risk women and girls who are
not inclined to visit traditional medical settings. The kit can be ordered on-line for home screening.
Background
and Larger Implications of Chlamydia and Gonorrhea Infections for Women
Sexually
Transmitted Diseases (“STDs”) are spreading globally with no apparent geographical limits. Chlamydia is one of the
most common sexually transmitted diseases. It is caused by the bacterium Chlamydia trachomatis, often with mild to no appreciable
symptoms. This is a significant issue. Although the infection is easily treatable, if the infection is not treated and left to
spread through the body unchecked, life-threatening and irreversible damage to the person with the disease can occur. Chlamydia
can also be transmitted by infected mothers to their babies during birth, and Chlamydia-infected people are five times more likely
to become infected with HIV, if exposed. The ease with which other infections promote themselves in Chlamydia-infected individuals
is due to weakened immune systems caused by the first infection. Today, Chlamydia is known as the “silent” bacteria
since 75% of infected individuals have no symptoms in the early stages. To help contain the spread of this infection, an annual
screening for Chlamydia is recommended for all sexually active and pregnant women. One of the greatest advantages of our technology
is that it allows the patient to auto-sample at home or work, without having to go to the clinic go in person.
According
to the World Health Organization more than 90 million new cases (male/female) occurring each year worldwide. In the United States
alone: 4 million new cases occur each year and only 1/3 of 22 million American woman that should be tested yearly are actually
tested. Public Health Agency of Canada, more than 40,000 young women are diagnosed with Chlamydia each year in Canada alone, and
they represent only a fraction of the number of young women with the infection. In a majority of cases, in both women and men,
Chlamydia is an asymptomatic (symptomless) infection. According to the Center for Disease Control in the United States, an untreated
Chlamydia infection may lead to pelvic inflammatory disease (PID), ectopic pregnancy, chronic pelvic pain, and infertility. Chlamydia
infections contribute to increased risk for HIV infections due to inflammation and the fact that immune cells leave their normal
places in the body and migrate to the site of the Chlamydia infection.
If
untreated, about 10-15% of women with Chlamydia will develop Pelvic Inflammatory Disease (“PID”). Chlamydia can also
cause an infection in the fallopian tubes which may not present any symptoms. PID and “silent” infections of the upper
genital tract can cause permanent damage to the fallopian tubes, uterus, and surrounding tissues, thus leading to infertility.
In addition, Chlamydia infections contribute to increased risk for HIV infections due to inflammation and the drafting of immune
cells to the site of the Chlamydia infection. Additionally, women who are affected by Chlamydia
during
pregnancy tend to
have greater risks of infection of the amniotic sac and fluid, premature birth, and preterm membrane rupture (“PPROM”).
Infection can easily be passed to the fetus during birth. Neonatal conjunctivitis is a common infection caused by Chlamydia that
affects the baby’s eyes. This conjunctivitis can severely damage a newborn’s eyes and causes scarring and even permanent
blindness. It is important that women know their sexual health status and that they receive treatment, as Chlamydia not only is
harmful to them but to their babies. Due to its asymptomatic nature, women infected by Chlamydia are less likely to be aware of
the infection, and are therefore highly vulnerable to the more extreme health consequences of the infection. Women in the 15-19
and 20-24 age groups are more than twice as likely to be diagnosed with the infection as similarly aged men. Because reported
rates are based only on diagnosed cases, testing is key to monitoring infection rates. Getting tested on a regular basis is very
important.
When
someone is diagnosed with Chlamydia, their doctor will generally prescribe oral
antibiotics
. Either one single dose of
azithromycin
or a regimen of
doxycycline
twice daily for 7 to 14 days are typically enough to cure the infection.
The doses are the same for those with or without HIV. With rapid treatment, infections generally clear up in a week. Although
medication will eradicate the infection, it will unfortunately not repair any permanent damage done by the disease, such as infertility
or child blindness. Regular screening for those at risk is highly recommended. The company’s home screening kit is safe,
easy, affordable, reliable and anonymous. The Company intends to further develop the MSN-2 technology, to screen for other prominent
STDs such as Gonorrhea and Thichomoniasis, all from a single collected sample.
Other
Testing Methods and Benefits of MSN-2 Device
Chlamydia
is usually detected by PCR (Polymerase Chain Reaction) testing of either first-catch urine or a sample taken by urogenital swab.
PCR analysis is a laboratory technique that identifies small amounts of DNA in a sample by a process known as
amplification
.
During PCR amplification, the DNA of interest is copied repeatedly until there is enough of it for analysis and detection. For
example, PCR can be used to identify small amounts of DNA from the organisms that cause Gonorrhea or Chlamydia that are present
in a urine sample. The sensitivity of this test may be less than optimal if the infection is situated in the uterine cervix. Conversely,
some infected women may harbor Chlamydia only in their urethra, which can increase the chance of misdetection from specimens taken
endocervically or by vaginal swab. With these issues presenting themselves testing on a single specimen frequently fails to identify
some infected women. The MSN-2 modified panty liner, is worn by a woman for only four (4) hours, which allows the pad to collect
enough specimen cells for laboratory analysis, without the worry of misdetection. Additionally, specimens collected by the Company’s
MSN-2 device are significantly more stable both over time and as to temperature fluctuations. This makes the samples significantly
easier and cheaper to handle and send to a laboratory, cutting down on costs of processing and logistical issues significantly
since samples may be sent by commercial courier or even by post. Conversely the collection of urine samples must be refrigerated
and samples deteriorate substantially in 48 hours.