Regencell Bioscience Holdings Limited (NASDAQ: RGC):
Results of EARTH efficacy trial
EARTH Efficacy Trials
Period of trial
30 January 2022 – 31 March
2022 (EARTH-B Trial)
1 October 2021 – 31 January
2022 (EARTH-A Trial)
1 October 2021 – 31 March 2022
(EARTH-A and EARTH-B Trials, combined)
Number of patients
51
37
88
Complete symptoms elimination in 6 days
(% of patients)
94.1
97.3
95.5
Elimination of one or more symptoms
after 1 full dose of RGC-COV19TM (% of patients)
90.2
83.8
87.5
Testing negative in 6 days (% of
patients)
23.5
43.5
29.7
Recovery period for patients who took
RGC-COV19TM within 3 days of symptoms onset (days)
3.7
3.2
3.5
Recovery period for patients who took
RGC-COV19TM between 4-5 days of symptoms onset (days)
2.3
3.6
3.4
No longer experienced difficulty
breathing and/or persistent chest pain after 1 full dose of
RGC-COV19TM (% of patients)
57.1
66.7
66.7
Regencell Bioscience Holdings Limited (NASDAQ: RGC)
(“Regencell” or the “Company”) today announced the
results from an analysis of a total of 51 individuals enrolled in
its additional Evaluation and
Assessment of RGC-COV19TM TCM through a Holistic approach efficacy trial (the
“EARTH-B Trial”) conducted by Regencell Bioscience Asia
Limited (“Regencell Asia”) of its novel COVID-19 oral TCM
candidate RGC-COV19TM (Regencell Bioscience (RGCA-CV01) liquid
formulation). These results are consistent with the earlier
analysis announced in February 2022 (the “EARTH-A Trial”),
showing RGC-COV19TM is effective in reducing and eliminating
COVID-19 symptoms within 6 days, which in turn reduces the risk of
hospitalization and death. The results have yet to be
peer-reviewed.
“Regencell is committed to delivering alternative treatments
that are safe and effective through the use of Traditional Chinese
Medicine (“TCM”). Rigorous trials have been conducted and
results have shown noticeable improvement in COVID-19 symptoms
among our trial participants following the administration of
RGC-COV19TM. Following the EARTH-B Trial’s results corroborating
the effectiveness of RGC-COV19TM, we believe RGC-COV19TM can be a
potential treatment that helps rehabilitate COVID-19 patients,”
said Ji Yang Lee (Jay), CEO of Regencell Asia.
While emerging new COVID-19 variants continue to remain a threat
to the public health, Regencell will continue to work in tandem
with its R&D units to develop new breakthroughs designed to
transform the way COVID-19 is being managed globally and provide
safe and effective treatment for everyone.
About EARTH
The primary objective of EARTH is to evaluate and assess the
efficacy of Regencell’s TCM – RGC-COV19TM (Regencell Bioscience
(RGCA-CV01) liquid formulation) in reducing and eliminating
COVID-19 symptoms through a holistic approach within a 6-day
period.
The EARTH B Trial was conducted in Malaysia from 30 January 2022
until 31 March 2022, when Omicron represented 80% of the COVID-19
cases in Malaysia since 10 January 2022, replacing Delta as the
dominant COVID-19 strain. The eligibility criteria for enrolment
remained the same as the earlier efficacy trial, requiring all
patients to have laboratory confirmation of SARS-CoV-2 infection
within 3 days prior to treatment and with symptoms onset within 5
days prior to treatment.
Based on the above-mentioned criteria, patients who were
asymptomatic were rejected and a larger cohort of 51 random
individuals qualified and were enrolled for the EARTH-B Trial, as
compared to 37 random individuals in EARTH-A Trial. The enrolled
patients were between the ages of 11 to 75 and of different races,
ethnic backgrounds and socioeconomic backgrounds. All 51
individuals were based in Kuala Lumpur, Malaysia. 48 out of the 51
enrolled patients started taking RGC-COV19TM within 3 days of
symptoms onset and the remaining 3 patients started taking
RGC-COV19TM between 4 to 5 days of symptoms onset.
Regencell Asia set a maximum of 6 days of treatment per patient.
Enrolled patients were required to report their COVID-19 symptoms
every day according to 3 severity categories (mild, moderate and
severe) and the list contained symptoms such as fever, fatigue,
cough, sore throat, runny nose, headache, nausea, feeling hot,
chills, drowsy, shortness of breath, persistent chest pain or
pressure, muscle ache and abdominal discomfort. Patients were also
asked to identify any other symptoms they were experiencing. Each
patient received 2 days of treatment progressively while a reverse
transcription polymerase chain reaction (RT-PCR) test was conducted
every 2 days.
Whenever a patient’s RT-PCR test result turned negative or
patients no longer had any COVID-19 symptoms (save for Sensory
Dysfunction or occasional cough) within the 6-day treatment period,
the treatment ended. While receiving the TCM treatment, 50
individuals were fully vaccinated and 1 child below 12 years old
was not vaccinated. At the end of the treatment, the total number
of patients whose symptoms were completely eliminated within the
6-day treatment period, save for Sensory Dysfunction and occasional
cough, were recorded to determine the efficacy.
About the EARTH-B Trial’s Results
Efficacy of complete symptoms elimination
within the 6-day treatment period
Results from this analysis of 51 trial participants build upon
and corroborate previously released data and demonstrate the
effectiveness of RGC-COV19TM in eliminating COVID-19 symptoms
within 6 days.
Of the 51 patients, 48 patients (representing 94.1% of the
patients) had all their mild to moderate COVID-19 symptoms
eliminated, save for Sensory Dysfunction and occasional cough,
within the 6-day treatment period. 17 out of the 51 patients
experienced Sensory Dysfunction and among those 17 patients, 11
recovered their sensory functions while the remaining 6 showed
improvements at the end of the 6-day treatment period.
Out of the 48 patients, the number of days it took for all
symptoms to be eliminated, save for Sensory Dysfunction and
occasional cough, within the 6-day treatment period, was 1 day = 3
patients, 2 days = 14 patients, 3 days = 9 patients, 4 days = 13
patients, 5 days = 4 patients, and 6 days = 5 patients.
Symptoms elimination after 1 full dose of
RGC-COV19TM
In this analysis, a higher percentage of COVID-19 patients
(90.2% compared to the previous efficacy trial of 83.8%), reported
the elimination of one or more symptoms after taking 1 full dose of
RGC-COV19TM, with the largest number of symptoms eliminated after 1
day of treatment reported by a patient being 8. The average number
of days it took from the start of treatment for all 51 patients to
eliminate all symptoms, save for Sensory Dysfunction and occasional
cough, was approximately 3.6 days. The largest number of different
symptoms reported by patients was 16 and the average number of
different symptoms reported was approximately 7.
Treatment leading to negative
RT-PCR
12 patients (representing approximately 23.5%) tested negative
RT-PCR within the 6 days treatment (Negative RT-PCR in 2 days = 6
patients, 4 days = 6 patients). Since the start of the treatment,
the average days taken for these 12 patients to test negative were
3 days. The minimum and maximum days taken for patients to test
negative were 2 and 4 days, respectively. 36 patients had all
symptoms eliminated, save for Sensory Dysfunction and occasional
cough, within 6 days (average approximately 3.4 days) and therefore
was not further tested to obtain a negative RT-PCR result.
Taking the treatment within 3 days from
symptoms onset vs within 4 to 5 days from symptoms onset
The recent analysis showed that 48 out of the 51 patients
started taking RGC-COV19TM within 3 days from symptoms onset and
they took an average of approximately 3.7 days for the elimination
of all symptoms, save for Sensory Dysfunction and occasional cough,
whereby the maximum number of different symptoms reported by any
one individual was 16 and the average number of different symptoms
reported was 8.
The remaining 3 patients who started taking RGC-COV19TM between
4 to 5 days from symptoms onset took an average of approximately
2.3 days for the elimination of all symptoms, save for Sensory
Dysfunction and occasional cough, whereby the maximum number of
different symptoms reported by any one individual was 8 and the
average number of symptoms reported was 5.
Vaccination status
50 individuals were fully vaccinated and 1 child below 12 years
old was not vaccinated. All 12 patients who tested negative RT-PCR
in 4 days were fully vaccinated prior to taking the RGC-COV19TM
treatment. All patients who were vaccinated received vaccine from
either Pfizer-BioNTech, AstraZeneca or Sinovac-CoronaVac, which are
the top 3 vaccines distributed in Malaysia.
High-risk patients
Out of the 51 patients, 15 patients experienced a combination of
dyspnea (difficulty breathing) and/or persistent chest pain. 10 of
these 15 patients no longer experienced difficulty breathing and/or
persistent chest pain after 1 full dose of RGC-COV19TM.
No adverse side effects
Based on the patients’ self-reported data, there were no
worsening of symptoms during and after consuming RGC-COV19TM and
none of the patients experienced any unknown adverse side
effects.
No treatment emergent adverse
events
Among the patients with chronic conditions such as chronic
migraine, eczema, asthma, thyroid disease, high blood pressure and
high cholesterol, there were no treatment emergent adverse events
and no discontinuation of RGC-COV19TM due to adverse results.
Death/Hospitalization
At the end of the EARTH-B Trial, none of the patients was
hospitalized and there was no death. The efficacy of RGC-COV19TM
was not affected by timing of symptom onset or underlying risk
factors. Results were consistent across all ages, gender, races and
ethnicity demographic among the enrolled patients.
More about EARTH
There are hundreds of millions of individuals who have been
diagnosed with COVID-19 around the world, and some experience
post-COVID symptoms such as extreme tiredness (fatigue), shortness
of breath, problems with memory and concentration (brain fog),
heart palpitations, dizziness, chest pain or tightness, joint pain
which are now being classified as long-COVID symptoms.
As long-COVID symptoms have substantial effects on individuals’
quality of life and work capability, Regencell Asia is in the midst
of conducting its studies for long-COVID patients using a natural
and holistic formula - RGC-COV19TM (RGCA-LCV01).
About RGC-COV19TM
RGC-COV19TM (RGCA-CV01) is an investigational, natural, orally
administered liquid formula which aims to reduce and eliminate
COVID-19 symptoms.
RGC-COV19TM is a natural formula designed by the TCM
Practitioner according to the TCM Practitioner’s brain theory known
as “Sik-Kee Au TCM Brain Theory®” and can be taken safely for two
to three weeks. In conducting EARTH, the treatment was limited to 6
days in order to evaluate its efficacy in reducing and eliminating
COVID-19 symptoms. The “TCM Practitioner” refers to our strategic
TCM research partner, Sik-Kee Au, father of our founder and Chief
Executive Officer.
According to the brain theory, brain functions depend on the
oxygen level required for the brain to perform normal cognitive
functions. For optimal brain performance, the heart needs to
function normally to deliver sufficient oxygen to the brain. When
the heart is weakened, the heart’s ability to deliver enough blood
to circulate oxygen throughout the body is impaired. When this
happens, brain functions are suppressed, resulting in a person
experiencing fatigue, nausea, disorientation and reduced immune
response.
RGC-COV19TM is designed to strengthen the heart’s functions.
According to the brain theory, when the heart is strengthened, it
increases blood flow and delivers more oxygen to the brain,
resulting in reduced blood clots and restored brain functions.
Regardless of the COVID-19 variant, the lungs and heart are where
the coronavirus does much of its damage by setting off an
inflammatory immune response that ravages infected and uninfected
cells alike, leading to tissue scarring and oxygen deprivation
which in turn suppress brain functions. RGC-COV19TM is formulated
to generate more responsive cognitive functions which in turn
stimulate the body’s own healing mechanism.
Regencell began its investigational approach towards COVID-19
treatment when a friend of Regencell contracted COVID-19 in March
2020. To treat his friend, the TCM Practitioner used his
proprietary TCM formula which he has been using over the past 30
years to treat various cold and flu patients, including during the
2003 SARS outbreak. The TCM Practitioner subsequently treated 9
voluntary COVID-19 patients in the United States using the
proprietary TCM formula.
Study results showed that the treatment was effective. As
Regencell has a mission to save lives, improve patients’ well-being
and address unmet needs in the market, Regencell aims to make its
natural and holistic treatment available to everyone in need.
From March 2020 to August 2021, Regencell set up protocols and
procedures to conduct the EARTH efficacy trial in Malaysia and the
United States.
RGC-COV19TM is designed to reduce COVID-19 symptoms such as
fever, fatigue, cough, sore throat, runny nose, headache, nausea,
chills, drowsiness, shortness of breath, persistent chest pain and
muscle ache as the medicine works to (i) reduce and clear the mucus
and phlegm from the upper respiratory system; (ii) dispel exterior
viral pathogen via heavy sweats, urine and excrement; (iii) clear
endogenous and liver heat; (iv) detox the liver; and (v) improve
body circulation. By applying the TCM Practitioner’s “Sik-Kee Au
TCM Brain Theory®”, RGC-COV19TM is also designed to remove blood
clots from the brain and restore the patient's brain functions.
RGC-COV19TM (RGCA-CV01) is administered at 1 dose of
RGCA-CV01-1Na (approximately 230ml) and 1 dose of RGCA-CV01-2Da
(approximately 230ml) each time, with 1 dose of RGCA-CV01-1Na to be
taken starting from the night of the first day of treatment and 1
dose of RGCA-CV01-2Da to be taken after lunch the next day, until
symptoms are eliminated.
About Regencell Bioscience Holdings Limited and Regencell
Bioscience Asia Limited: Breakthrough in TCM formulae designed to
save and improve lives
For more than 30 years, the TCM Practitioner whom Regencell
partners with has treated patients with neurological disorders and
infectious diseases. The TCM Practitioner’s TCM formulae candidates
are derived from a TCM base formula and an adjustable formula which
is developed based on his TCM brain theory, known as the “Sik-Kee
Au TCM Brain Theory®”.
Both Regencell and the TCM Practitioner are committed in giving
back to the society and demonstrates its CARE through
Caring for patients,
Accountability by maintaining a
high standard of quality and integrity, Respect by valuing partnerships, teamwork and
harmony and the Enthusiasm to
improve the life of the underprivileged.
Since its listing, Regencell through a joint venture with Honor
Epic Enterprises Limited, formed Regencell Bioscience Asia Limited
to offer COVID-19 related treatments to patients in ASEAN
countries, India, Japan, Australia and New Zealand, as Regencell
aspires to be the global market leader for the provision of natural
and holistic treatment for neurological disorders and infectious
diseases. For more information, visit www.regencellbioscience.com
and www.regencellasia.com.
Forward-looking Statements
This press release contains “forward‐looking statements” within
the meaning of applicable laws, including U.S. federal securities
laws. These forward-looking statements may include, but are not
limited to, statements relating to our objectives, plans, and
strategies; statements that contain projections of results of
operations or of financial condition; statements relating to the
research, development, and use of our platform technologies,
technologies, products and product candidates, including with
respect to our Investigational Liquid-Formula RGC-COV19TM; and all
statements that address activities, events, or developments that we
intend, expect, project, believe, or anticipate will or may occur
in the future. The risks and uncertainties of our company include:
our ability to obtain regulatory approval and ultimately
commercialize our TCM formulae and/or products based on our TCM
formulae; the outcome of our research study free from biases of
parents or caregivers of patients because we relied on the data
provided by them; difficulties enrolling patients in our research
studies; any undesirable side effects caused by the TCM formulae
candidates which could delay or prevent their regulatory approval
or hinder commercialization; whether results of our earlier studies
on personalized TCM formulae can be predictive of future research
study results; failure of the research and development process;
whether any TCM formulae candidates can be developed, manufactured,
sold, marketed and distributed; the ability to successfully
commercialize any future therapeutics; our ability to enhance our
brand recognition; our ability to obtain and protect our
intellectual property; and any adverse publicity associated with
our TCM formulae candidates, ingredients or network marketing
programs. We have based these forward-looking statements on
assumptions and assessments made by our management in light of
their experience and their perception of historical trends, current
conditions, expected future developments, and other factors they
believe to be appropriate. We have also relied upon and assumed,
without independent verification, the accuracy and completeness of
all information available from public sources and makes no express
or implied warranty as to the accuracy or completeness of any such
information. Even if our results of operations, financial condition
and liquidity, and the development of the industry in which we
operate are consistent with the forward-looking statements
contained in this presentation, they may not be indicative of
results or developments in future periods. For a discussion of
these and other risks and uncertainties, see our Annual Report on
Form 20-F for the year ended June 30, 2021, which is available on
the SEC’s website at www.sec.gov. All information in this press
release is as of the date of the release, and we undertake no duty
to update this information unless required by law. This caution is
made under the safe harbor provisions of Section 21E of the Private
Securities Litigation Reform Act of 1995.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220518005682/en/
Investor Relations James Chung ir@rgcbio.com +852 2155 0823
Regencell Bioscience (NASDAQ:RGC)
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