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June 12, 2012
Findings of research into the history of ASEA
Note: None of the statements in this document have been reviewed or endorsed by
ASEA Corporate, and are solely based on findings in publicly available information:
Press releases, SEC filings, and Industry analyst publications.
SUMMARY
The Asea product was previously known as MDI-P, which was developed and initially
patented in the early 1990s by a development-stage Bio-Tech Company, Medical
Discoveries, Inc., a publicly traded company, which was closely watched and thought of as
promising by industry analysts.
MDI-P was initially discovered and used as an anti-bacterial for dental instruments outside
the human body. Because of its effectiveness in treating certain viruses, bacteria and fungi
without levels of toxicity, it was initially targeted at treating HIV in humans. The vision of the
company was to provide the world a cure for AIDS.
The company was granted multiple patents for not only the product MDI-P, but the
manufacturing process of creating the electrolyzed solution, which also had to be proven to
satisfy and comply with all associated FDA regulations.
The company proceeded for several years with the FDA process for an IND (Investigational
New Drug) application, and proceeded accordingly. The process is well-known, documented,
and required extensive pre-clinical testing for efficacy and toxicity, with several million dollars
being spent on the clinical research.
Pre-clinical results are well-documented, providing evidence that MDI-P was effective in lab
tests, and animal tests for an even wider array of health-related issues, blood disorders and
diseases - HIV, Cystic Fibrosis, Heart Disease, Asthma, and other blood-related disorders,
to name a few.
SEC filings assert the company’s belief that MDI-P had much broader applicability.
(See below for some examples of publicly available information.)
Results of the company’s efforts to satisfy FDA requirements to provide LD50 data, which is
required for all New Drug applications, demonstrated that MDI-P could not be proven to be
harmful in testing to the point of a “Lethal Dose”. Some believe that this is the point at which
the company realized that MDI-P would not be classified as a drug at all, and ceased the path
for a New Drug application.
Note: The path for FDA approval requires a lot of time and funding. The financial impact of
the process appears to have affected the ability of the company to satisfy FDA requirements
as well as the financial viability of the company. The financial decline of the company is also
well documented in SEC filings.
The company was sold to Global Clean Energy Holdings, Inc.
Asea executives tell the rest of the story.
Verdis Norton was on the Board of Medical Discoveries, Inc , and learned enough about
MDI-P to invest in the assets, to first pursue the “pharmaceutical path” and subsequently
make the investment to found the Asea company.
Dana-Farber Cancer Institute To Investigate Mechanism Of AIDS Treatment
January 5, 1999
Medical Discoveries, Inc. and the Dana-Farber Cancer Institute (DFCI), a teaching affiliate of
Harvard Medical School (HMS) and an NIH-approved AIDS Research Laboratory, have
signed a "Research Support Agreement" to confirm and extend the anti-HIV activity of the
novel drug therapy, MDI-P.
Preliminary studies of Medical Discoveries' MDI-P treatment have demonstrated a decrease
in the production of HIV-1. The Research Plan will further investigate the mechanism by
which MDI-P inactivates the virus, and will define its cellular and viral specificity. Importantly,
the DFCI will be testing the activity of MDI-P against resistant strains of HIV and against fresh
samples of HIV taken from the patient.
All research under this agreement will be conducted under the direction of Dr. Robert
Finberg, the principal investigator of the study, a professor of Medicine at HMS and chief of
Infectious Disease at the DFCI.
Dr. William J. Novick, vice president and chief technical officer of Medical Discoveries says
the MDI-P research is important because the treatment works on mechanisms which are
different from those targeted by currently approved anti-retroviral agents. "We can
categorically say that this drug is not an enzyme inhibitor," Novick says. "I feel very strongly
that the potential of this drug against the resistant strains of HIV is every bit as good as
against the normal wild strains."
For more information: Dr. William J. Novick, vice president and chief technical
officer, Medical Discoveries, Inc., telephone: (801)-771-0523
PHARMACEUTICAL DRUG DISCOVERY AND DEVELOPMENT ACTIVITIES
MDI has completed a series of validation testing at the Dana-Faber Cancer Institute, a
Harvard Medical School teaching Affiliate and National Institute of Health (NIH) approved
HIV/AIDS Testing Laboratory.
These tests confirmed and extended previous research and testing which demonstrated that
MDI-P is shown to be capable of killing HIV in cell cultures without mortality to the cells.
A six-month Research Grant with the Dana-Farber Cancer Institute to further extend and
confirm the anti -HIV/AIDS activity of MDI-P is in progress. In this Research, MDI-P is being
analyzed for effectiveness in killing laboratory strains of HIV-1; clinical specimens of HIV; and
resistant strains of HIV-1. These test results continue to support the effectiveness or MDI-P in
killing the HIV Virus.
During its current research testing, the Company has become aware of the need to address
certain technical issues regarding the electrolysis equipment used to produce MDI-P during
initial manufacture.
MDI has temporarily suspended validation testing at the Dana-Farber Cancer Institute of its
novel drug "MDI-P" targeted at the HIV/AIDS disease due to certain technical issues.
Although the testing performed during the last quarter, which demonstrated MDI-P to be
capable of killing HIV in cell cultures without mortality to the cells, remains valid, the
Company has decided to temporarily suspend further investigation until such time as these
technical issues are resolved. Work is already in progress to develop a permanent solution to
these minor technical issues.
Toxicology studies initiated in October of 1998 were completed during the first quarter. A final
report will be available upon completion by the Company of final payments to the testing
Laboratory. MDI has also initiated microbiology studies during the first quarter; however,
these studies have been suspended pending availability of appropriate levels of funding.
Progress of the Company's plan for submission to the FDA of an IND Application has been
delayed, and continuation depends on the ability of the Company to successfully address
certain technical issues, and the ability of the Company to obtain sufficient funding enabling
the completion of the toxicity, microbiology, and chemical characterization studies in various
stages of progress. See "Additional Funding is Required" section below. While results to date
continue to show promise, the Company can provide no assurance the technology will
eventually be proven.
Excerpt from Edgar On-Line for Medical Discoveries Inc.
Item 1. Description of Business
OVERVIEW
We are a development-stage bio-pharmaceutical company engaged in the research,
validation, development and ultimate commercialization of a patented anti-infective
technology. Our electrolyzed solution of free radicals represents a novel approach to treating
our initial target indication, HIV. We plan in the near future to conclude our pre-clinical work
and enter the clinic in our initial target indication. If our HIV clinical trials are successful, we
plan to develop this therapy for additional target indications.
Our product, called MDI-P, appears to have the ability to destroy certain viruses, bacteria
and fungi without any associated toxicity both in animals and in cell-based assays. We are
committed to the development of MDI-P as an anti-infective therapeutic product for in-vitro
and in-vivo applications. Our highest priority is to develop and commercialize MDI-P as a
pharmaceutical for the treatment of HIV. We are in the process of completing pre-clinical
development and plan to file an Investigative New Drug application (IND) with the Food and
Drug Administration (FDA) for MDI-P as an HIV treatment. If the FDA approves the IND, we
will begin a Phase I clinical test at the Harvard School of Medicine using a protocol designed
by Dr. Bruce Dezube. We expect to add additional indications for the use of MDI-P in the
future as we complete our pre-clinical development.
To date, we have not generated significant revenues from operations or realized a profit.
Through December 31, 2003, we had incurred a cumulative net loss since inception of
$14,141,763. We are currently attempting to secure capital commitments to finance the
completion of our pre-clinical analysis, file our IND for MDI-P as an HIV therapeutic,
determine additional potential indications for MDI-P, and to otherwise continue research and
testing of our technologies in order to secure required approvals to bring products to market.
In that we are a development stage company, we will increasingly require additional funding
to continue the development of our technology and to finance submittal of our testing and
trials to the appropriate regulatory agencies in order to secure approvals for product
development and sales.
RECENT DEVELOPMENTS
Sepsis Study Reaffirms Anti-Infective Strength and Low Toxicity of MDI-P.
In March, 2004, we received a study on sepsis that reaffirms the anti-infective strength and
low toxicity profile in pre-clinical mouse models of MDI-P. In the MDI-sponsored study, the
goal was to test the efficacy of MDI-P in inhibiting inflammatory responses in mice, induced
by bacteria that cause sepsis, a severe illness caused by infection of the bloodstream by
toxin-producing bacteria. The study used 25%, 50% and 100% MDI-P solutions to inhibit
inflammatory processes that generally lead to septic shock. MDI-P was evaluated against
both a saline control group of mice and a positive control group that had been given
Gentamicin, an established antibiotic treatment for sepsis. The study confirmed that 100%
dose strength of MDI-P offered substantial benefit to the mice when compared to both the
placebo and to Gentamicin, but without the apparent toxicity profile that Gentamicin exhibits.
While HIV is our initial target indication, this report is significant.
In the US, sepsis is the leading cause of death in non-coronary ICU patients, and recent 1998
data from the Centers for Disease Control show that it is the 11th leading cause of death
overall. Despite enormous investments in intensive care, sepsis has been associated with
mortality rates ranging from 28% to 50%. It is estimated that more than 700,000 cases of
severe sepsis occur in the US each year, resulting in more than 200,000 deaths.
Extrapolated to a global population, this represents several million cases of severe sepsis
annually worldwide with a mortality of up to 1 million cases. This research is one of several
studies on pre-clinical models of infectious diseases that mimic human disease, being
conducted by Dr. Emil Chi, Director of the University of Washington Medical School’s
Department of Histopathology. This and Dr. Chi’s other studies will help support our IND for
HIV.
Asthma (Press Release by Medical Discoveries, Inc)
2004 MAY 20 - (NewsRx.com & NewsRx.net) -- Medical Discoveries, Inc., (MLSC)
(MDI) announced the receipt of its second in a series of preclinical reports from
Dr. Emil Chi, chairman of the department of histopathology at the University
of Washington Medical School.
This trial, one of several studies on models of disease which mimic human
disease, focused on MDI-P as a potential therapeutic agent for the treatment of
the symptoms of asthma.
In the late 1990s, Chi developed a now-standard mouse model to assess asthma
therapeutic agents for efficacy and toxicity. This model is believed to have at
least an 80% predictive value of results in humans.
In the study, 36 female mice were examined in a chronic asthma model, using
various doses of MDI-P as a therapeutic agent as measured against saline
control. Samples of bronchial lavage lung fluid and tissue were taken from all
mice, with assays performed in airway mucus build-up and eosinophil infiltration,
a prime blood cell measure of asthmatic attacks.
More than 70% of the MDI-P-treated mice exhibited no increase in mucus
secretions, comparable with saline control animals, with a marked reduction in
eosinophil infiltration. Untreated asthmatic mice, in contrast, had more than a 9-
fold increase in mucus build-up as compared with saline controls. Further, no
toxicity was found in the MDI-P treated mice.
MDI President and CEO Judy Robinett commented: "To the best of our knowledge
of other published studies in clearing mucus plugs in the same mouse model,
there is no product on the market or soon to be released from pharmaceutical
pipelines which accomplishes a similar clearing of mucus plugs in the majority of
treated chronic asthmatic mice. From this test, we speculate that MDI-P may
prove to be a very beneficial agent exhibiting minimal toxicity for
addressing asthma attacks."
Robinett continued: "This study and the other preclinical studies of MDI-P are
required for filing our investigational new drug (IND) application later this year
with the FDA [U.S. Food and Drug Administration] for our primary target use for
MDI-P, which is treating humans with HIV.
"These studies test MDI-P on animal models of diseases which mimic those of
humans. There is not an animal test relevant to HIV/AIDS in humans, so we are
testing MDI-P on other standard animal/mimicking human models, such as our
recently reported sepsis results, in order to determine if there is any potentially
significant toxicity to humans related to usage of MDI-P. This report, in addition
to other preclinical reports and our CMC [chemistry, manufacturing, and
controls]/CGMP [current good manufacturing practices] data, will allow us to file
an IND with the FDA for our initial target indication, HIV, and enter clinical trials
sometime late in 2004 or early in 2005, continuing the path to
commercialization."
Formed in 1991, Medical Discoveries, Inc., is a publicly traded, development-
stage biopharmaceutical research company. This article was prepared
by Women's Health Weekly editors from staff and other reports. Copyright 2004,
Women's Health Weekly via NewsRx.com &NewsRx.net.
©Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net
return to OBGYN.net Headline News ... (2001 archives)
	
  
Press	
  Release	
  by	
  Medical	
  Discoveries	
  2004	
  
Good News for Medical Discoveries, Inc. From Latest Toxicological Research;
Pre-IND Tests Reveal No Systemic Adverse Effects From MDI-P
SALT LAKE CITY, Jan. 9 /PRNewswire/ -- Medical Discoveries Inc.
(OTC Bulletin Board: MLSC) announces that test results from WIL
Research Laboratories have indicated that MDI-P, the company's
proprietary AIDS drug, produced no systemic toxicity in laboratory
animal tests used to assess potential problems for human
application.
"Demonstrating a lack of systemic toxic effects is another
accomplishment in our continuing effort to obtain regulatory
approvals for MDI-P," said Judy Robinett, MDI President and Chief
Executive Officer.
"These data have helped establish that our product, MDI-P, is
reasonably safe for human Phase I/II clinical trials. Medical
Discoveries, Inc. will continue to sponsor research activities that
will lead to a successful IND(Investigative New Drug) application,
which is required by the FDA prior to any actual testing in humans
in the United States."
According to Dr. William Novick, MDI board member who coordinated
the research project: "These studies were conducted following FDA
guidelines and demonstrated that MDI-P was free of systemic toxicity
in two animal species, using repeated drug administration at dose
levels which were several magnitudes above the expected dose in
humans. The only adverse effect noted was a local irritation at the
injection site. This will be carefully monitored in any future
human trials. The conclusion of these studies marks a major step
forward in the development of MDI-P for human use."
Formed in 1992, Medical Discoveries, Inc. is a publicly traded
(OTC Bulletin Board: MLSC) biopharmaceutical research company (as
defined in SFAS No. 7) engaged in the research, development and
validation of a new class of drugs, based upon the company's
patented and proprietary electrolysis technologies.
MDI is developing active anti-viral (HIV/AIDS), anti-bacterial and
anti-fungal agents for a variety of applications.
	
  
Excerpt	
  Regarding	
  UCLA	
  Studies	
  
UCLA	
  Test	
  Results	
  Support	
  MDI-­‐P	
  As	
  An	
  Effective	
  Anti-­‐Bacterial	
  Agent	
  
Tapping	
  first	
  into	
  the	
  sterilization	
  and	
  veterinary	
  treatment	
  industries,	
  Medical	
  Discoveries	
  intends	
  to	
  
generate	
  cash	
  flow	
  in	
  the	
  near	
  term	
  to	
  fund	
  the	
  commercialization	
  of	
  MDI-­‐P	
  as	
  a	
  broad-­‐spectrum	
  
anti-­‐bacterial	
  agent.	
  “There	
  is	
  an	
  urgent	
  need	
  to	
  find	
  new	
  anti-­‐	
  bacterial	
  agents	
  that	
  are	
  effective	
  
against	
  multiple	
  drug-­‐resistant	
  bacteria	
  and	
  against	
  new,	
  emerging	
  infections,”	
  states	
  P.B.	
  Fernandes,	
  
Vice	
  President	
  of	
  biomolecular	
  screening	
  and	
  drug	
  discovery	
  at	
  Bristol-­‐Myers	
  Squibb	
  Pharmaceutical	
  
Research	
  Institute.	
  According	
  to	
  Fernandes,	
  the	
  antibacterial	
  market	
  is	
  significant	
  with	
  yearly	
  global	
  
sales	
  estimated	
  at	
  over	
  $20	
  billion.	
  
A	
  series	
  of	
  preliminary	
  studies	
  were	
  completed	
  in	
  April	
  evaluating	
  MDI-­‐P	
  as	
  a	
  potential	
  broad-­‐
spectrum	
  anti-­‐bacterial	
  agent.	
  	
  Conducted	
  at	
  the	
  UCLA	
  (University	
  of	
  California,	
  Los	
  Angeles)	
  Clinical	
  
Microbiology	
  Laboratory,	
  the	
  studies	
  successfully	
  demonstrated	
  the	
  ability	
  of	
  MDI-­‐P	
  to	
  eliminate	
  in	
  
vitro	
  (outside	
  the	
  human	
  body)	
  several	
  types	
  of	
  antibiotic	
  resistant	
  bacteria,	
  including	
  Staphylococcus	
  
aureus,	
  E.	
  coli,	
  and	
  Enterocooccus	
  faecalis,	
  the	
  three	
  most	
  common	
  causes	
  of	
  hospital-­‐	
  acquired	
  
bacterial	
  infections.	
  The	
  next	
  step	
  for	
  MDI	
  is	
  to	
  complete	
  in	
  vivo	
  testing	
  per	
  FDA-­‐recommended	
  
criteria,	
  enabling	
  the	
  company	
  to	
  market	
  its	
  product	
  within	
  the	
  United	
  States.	
  
“The	
  results	
  of	
  the	
  UCLA	
  studies	
  have	
  helped	
  to	
  materially	
  enhance	
  the	
  potential	
  of	
  MDI-­‐P	
  as	
  a	
  
revolutionary	
  antibacterial	
  agent	
  for	
  many	
  emerging	
  bacterial	
  juggernauts,”	
  says	
  Zidell.	
  “We	
  look	
  
forward	
  to	
  completing	
  the	
  testing	
  phase	
  for	
  MDI-­‐P	
  as	
  a	
  bactericide	
  and	
  intend	
  to	
  translate	
  the	
  
significance	
  of	
  these	
  results	
  into	
  bottom-­‐line	
  success	
  over	
  the	
  long	
  term.”	
  He	
  also	
  indicates	
  that	
  the	
  
results	
  of	
  the	
  studies	
  also	
  form	
  a	
  basis	
  for	
  understanding	
  the	
  mechanistic	
  action	
  of	
  MDI-­‐P	
  and	
  will	
  be	
  
included	
  in	
  the	
  company’s	
  IND	
  (Investigational	
  New	
  Drug)	
  submission	
  to	
  the	
  Food	
  and	
  Drug	
  
Administration	
  for	
  MDI-­‐P’s	
  application	
  as	
  an	
  HIV/AIDS	
  therapy.	
  

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Asea history

  • 1. June 12, 2012 Findings of research into the history of ASEA Note: None of the statements in this document have been reviewed or endorsed by ASEA Corporate, and are solely based on findings in publicly available information: Press releases, SEC filings, and Industry analyst publications. SUMMARY The Asea product was previously known as MDI-P, which was developed and initially patented in the early 1990s by a development-stage Bio-Tech Company, Medical Discoveries, Inc., a publicly traded company, which was closely watched and thought of as promising by industry analysts. MDI-P was initially discovered and used as an anti-bacterial for dental instruments outside the human body. Because of its effectiveness in treating certain viruses, bacteria and fungi without levels of toxicity, it was initially targeted at treating HIV in humans. The vision of the company was to provide the world a cure for AIDS. The company was granted multiple patents for not only the product MDI-P, but the manufacturing process of creating the electrolyzed solution, which also had to be proven to satisfy and comply with all associated FDA regulations. The company proceeded for several years with the FDA process for an IND (Investigational New Drug) application, and proceeded accordingly. The process is well-known, documented, and required extensive pre-clinical testing for efficacy and toxicity, with several million dollars being spent on the clinical research. Pre-clinical results are well-documented, providing evidence that MDI-P was effective in lab tests, and animal tests for an even wider array of health-related issues, blood disorders and diseases - HIV, Cystic Fibrosis, Heart Disease, Asthma, and other blood-related disorders, to name a few. SEC filings assert the company’s belief that MDI-P had much broader applicability. (See below for some examples of publicly available information.) Results of the company’s efforts to satisfy FDA requirements to provide LD50 data, which is required for all New Drug applications, demonstrated that MDI-P could not be proven to be harmful in testing to the point of a “Lethal Dose”. Some believe that this is the point at which the company realized that MDI-P would not be classified as a drug at all, and ceased the path for a New Drug application. Note: The path for FDA approval requires a lot of time and funding. The financial impact of the process appears to have affected the ability of the company to satisfy FDA requirements as well as the financial viability of the company. The financial decline of the company is also well documented in SEC filings. The company was sold to Global Clean Energy Holdings, Inc.
  • 2. Asea executives tell the rest of the story. Verdis Norton was on the Board of Medical Discoveries, Inc , and learned enough about MDI-P to invest in the assets, to first pursue the “pharmaceutical path” and subsequently make the investment to found the Asea company. Dana-Farber Cancer Institute To Investigate Mechanism Of AIDS Treatment January 5, 1999 Medical Discoveries, Inc. and the Dana-Farber Cancer Institute (DFCI), a teaching affiliate of Harvard Medical School (HMS) and an NIH-approved AIDS Research Laboratory, have signed a "Research Support Agreement" to confirm and extend the anti-HIV activity of the novel drug therapy, MDI-P. Preliminary studies of Medical Discoveries' MDI-P treatment have demonstrated a decrease in the production of HIV-1. The Research Plan will further investigate the mechanism by which MDI-P inactivates the virus, and will define its cellular and viral specificity. Importantly, the DFCI will be testing the activity of MDI-P against resistant strains of HIV and against fresh samples of HIV taken from the patient. All research under this agreement will be conducted under the direction of Dr. Robert Finberg, the principal investigator of the study, a professor of Medicine at HMS and chief of Infectious Disease at the DFCI. Dr. William J. Novick, vice president and chief technical officer of Medical Discoveries says the MDI-P research is important because the treatment works on mechanisms which are different from those targeted by currently approved anti-retroviral agents. "We can categorically say that this drug is not an enzyme inhibitor," Novick says. "I feel very strongly that the potential of this drug against the resistant strains of HIV is every bit as good as against the normal wild strains." For more information: Dr. William J. Novick, vice president and chief technical officer, Medical Discoveries, Inc., telephone: (801)-771-0523
  • 3. PHARMACEUTICAL DRUG DISCOVERY AND DEVELOPMENT ACTIVITIES MDI has completed a series of validation testing at the Dana-Faber Cancer Institute, a Harvard Medical School teaching Affiliate and National Institute of Health (NIH) approved HIV/AIDS Testing Laboratory. These tests confirmed and extended previous research and testing which demonstrated that MDI-P is shown to be capable of killing HIV in cell cultures without mortality to the cells. A six-month Research Grant with the Dana-Farber Cancer Institute to further extend and confirm the anti -HIV/AIDS activity of MDI-P is in progress. In this Research, MDI-P is being analyzed for effectiveness in killing laboratory strains of HIV-1; clinical specimens of HIV; and resistant strains of HIV-1. These test results continue to support the effectiveness or MDI-P in killing the HIV Virus. During its current research testing, the Company has become aware of the need to address certain technical issues regarding the electrolysis equipment used to produce MDI-P during initial manufacture. MDI has temporarily suspended validation testing at the Dana-Farber Cancer Institute of its novel drug "MDI-P" targeted at the HIV/AIDS disease due to certain technical issues. Although the testing performed during the last quarter, which demonstrated MDI-P to be capable of killing HIV in cell cultures without mortality to the cells, remains valid, the Company has decided to temporarily suspend further investigation until such time as these technical issues are resolved. Work is already in progress to develop a permanent solution to these minor technical issues. Toxicology studies initiated in October of 1998 were completed during the first quarter. A final report will be available upon completion by the Company of final payments to the testing Laboratory. MDI has also initiated microbiology studies during the first quarter; however, these studies have been suspended pending availability of appropriate levels of funding. Progress of the Company's plan for submission to the FDA of an IND Application has been delayed, and continuation depends on the ability of the Company to successfully address certain technical issues, and the ability of the Company to obtain sufficient funding enabling the completion of the toxicity, microbiology, and chemical characterization studies in various stages of progress. See "Additional Funding is Required" section below. While results to date continue to show promise, the Company can provide no assurance the technology will eventually be proven.
  • 4. Excerpt from Edgar On-Line for Medical Discoveries Inc. Item 1. Description of Business OVERVIEW We are a development-stage bio-pharmaceutical company engaged in the research, validation, development and ultimate commercialization of a patented anti-infective technology. Our electrolyzed solution of free radicals represents a novel approach to treating our initial target indication, HIV. We plan in the near future to conclude our pre-clinical work and enter the clinic in our initial target indication. If our HIV clinical trials are successful, we plan to develop this therapy for additional target indications. Our product, called MDI-P, appears to have the ability to destroy certain viruses, bacteria and fungi without any associated toxicity both in animals and in cell-based assays. We are committed to the development of MDI-P as an anti-infective therapeutic product for in-vitro and in-vivo applications. Our highest priority is to develop and commercialize MDI-P as a pharmaceutical for the treatment of HIV. We are in the process of completing pre-clinical development and plan to file an Investigative New Drug application (IND) with the Food and Drug Administration (FDA) for MDI-P as an HIV treatment. If the FDA approves the IND, we will begin a Phase I clinical test at the Harvard School of Medicine using a protocol designed by Dr. Bruce Dezube. We expect to add additional indications for the use of MDI-P in the future as we complete our pre-clinical development. To date, we have not generated significant revenues from operations or realized a profit. Through December 31, 2003, we had incurred a cumulative net loss since inception of $14,141,763. We are currently attempting to secure capital commitments to finance the completion of our pre-clinical analysis, file our IND for MDI-P as an HIV therapeutic, determine additional potential indications for MDI-P, and to otherwise continue research and testing of our technologies in order to secure required approvals to bring products to market. In that we are a development stage company, we will increasingly require additional funding to continue the development of our technology and to finance submittal of our testing and trials to the appropriate regulatory agencies in order to secure approvals for product development and sales. RECENT DEVELOPMENTS Sepsis Study Reaffirms Anti-Infective Strength and Low Toxicity of MDI-P. In March, 2004, we received a study on sepsis that reaffirms the anti-infective strength and low toxicity profile in pre-clinical mouse models of MDI-P. In the MDI-sponsored study, the goal was to test the efficacy of MDI-P in inhibiting inflammatory responses in mice, induced by bacteria that cause sepsis, a severe illness caused by infection of the bloodstream by toxin-producing bacteria. The study used 25%, 50% and 100% MDI-P solutions to inhibit inflammatory processes that generally lead to septic shock. MDI-P was evaluated against both a saline control group of mice and a positive control group that had been given Gentamicin, an established antibiotic treatment for sepsis. The study confirmed that 100% dose strength of MDI-P offered substantial benefit to the mice when compared to both the placebo and to Gentamicin, but without the apparent toxicity profile that Gentamicin exhibits. While HIV is our initial target indication, this report is significant.
  • 5. In the US, sepsis is the leading cause of death in non-coronary ICU patients, and recent 1998 data from the Centers for Disease Control show that it is the 11th leading cause of death overall. Despite enormous investments in intensive care, sepsis has been associated with mortality rates ranging from 28% to 50%. It is estimated that more than 700,000 cases of severe sepsis occur in the US each year, resulting in more than 200,000 deaths. Extrapolated to a global population, this represents several million cases of severe sepsis annually worldwide with a mortality of up to 1 million cases. This research is one of several studies on pre-clinical models of infectious diseases that mimic human disease, being conducted by Dr. Emil Chi, Director of the University of Washington Medical School’s Department of Histopathology. This and Dr. Chi’s other studies will help support our IND for HIV. Asthma (Press Release by Medical Discoveries, Inc) 2004 MAY 20 - (NewsRx.com & NewsRx.net) -- Medical Discoveries, Inc., (MLSC) (MDI) announced the receipt of its second in a series of preclinical reports from Dr. Emil Chi, chairman of the department of histopathology at the University of Washington Medical School. This trial, one of several studies on models of disease which mimic human disease, focused on MDI-P as a potential therapeutic agent for the treatment of the symptoms of asthma. In the late 1990s, Chi developed a now-standard mouse model to assess asthma therapeutic agents for efficacy and toxicity. This model is believed to have at least an 80% predictive value of results in humans. In the study, 36 female mice were examined in a chronic asthma model, using various doses of MDI-P as a therapeutic agent as measured against saline control. Samples of bronchial lavage lung fluid and tissue were taken from all mice, with assays performed in airway mucus build-up and eosinophil infiltration, a prime blood cell measure of asthmatic attacks. More than 70% of the MDI-P-treated mice exhibited no increase in mucus secretions, comparable with saline control animals, with a marked reduction in eosinophil infiltration. Untreated asthmatic mice, in contrast, had more than a 9- fold increase in mucus build-up as compared with saline controls. Further, no toxicity was found in the MDI-P treated mice. MDI President and CEO Judy Robinett commented: "To the best of our knowledge of other published studies in clearing mucus plugs in the same mouse model, there is no product on the market or soon to be released from pharmaceutical pipelines which accomplishes a similar clearing of mucus plugs in the majority of treated chronic asthmatic mice. From this test, we speculate that MDI-P may prove to be a very beneficial agent exhibiting minimal toxicity for addressing asthma attacks." Robinett continued: "This study and the other preclinical studies of MDI-P are required for filing our investigational new drug (IND) application later this year
  • 6. with the FDA [U.S. Food and Drug Administration] for our primary target use for MDI-P, which is treating humans with HIV. "These studies test MDI-P on animal models of diseases which mimic those of humans. There is not an animal test relevant to HIV/AIDS in humans, so we are testing MDI-P on other standard animal/mimicking human models, such as our recently reported sepsis results, in order to determine if there is any potentially significant toxicity to humans related to usage of MDI-P. This report, in addition to other preclinical reports and our CMC [chemistry, manufacturing, and controls]/CGMP [current good manufacturing practices] data, will allow us to file an IND with the FDA for our initial target indication, HIV, and enter clinical trials sometime late in 2004 or early in 2005, continuing the path to commercialization." Formed in 1991, Medical Discoveries, Inc., is a publicly traded, development- stage biopharmaceutical research company. This article was prepared by Women's Health Weekly editors from staff and other reports. Copyright 2004, Women's Health Weekly via NewsRx.com &NewsRx.net. ©Copyright 2004, Women's Health Weekly via NewsRx.com & NewsRx.net return to OBGYN.net Headline News ... (2001 archives)   Press  Release  by  Medical  Discoveries  2004   Good News for Medical Discoveries, Inc. From Latest Toxicological Research; Pre-IND Tests Reveal No Systemic Adverse Effects From MDI-P SALT LAKE CITY, Jan. 9 /PRNewswire/ -- Medical Discoveries Inc. (OTC Bulletin Board: MLSC) announces that test results from WIL Research Laboratories have indicated that MDI-P, the company's proprietary AIDS drug, produced no systemic toxicity in laboratory animal tests used to assess potential problems for human application. "Demonstrating a lack of systemic toxic effects is another accomplishment in our continuing effort to obtain regulatory approvals for MDI-P," said Judy Robinett, MDI President and Chief Executive Officer. "These data have helped establish that our product, MDI-P, is reasonably safe for human Phase I/II clinical trials. Medical Discoveries, Inc. will continue to sponsor research activities that will lead to a successful IND(Investigative New Drug) application, which is required by the FDA prior to any actual testing in humans in the United States." According to Dr. William Novick, MDI board member who coordinated the research project: "These studies were conducted following FDA
  • 7. guidelines and demonstrated that MDI-P was free of systemic toxicity in two animal species, using repeated drug administration at dose levels which were several magnitudes above the expected dose in humans. The only adverse effect noted was a local irritation at the injection site. This will be carefully monitored in any future human trials. The conclusion of these studies marks a major step forward in the development of MDI-P for human use." Formed in 1992, Medical Discoveries, Inc. is a publicly traded (OTC Bulletin Board: MLSC) biopharmaceutical research company (as defined in SFAS No. 7) engaged in the research, development and validation of a new class of drugs, based upon the company's patented and proprietary electrolysis technologies. MDI is developing active anti-viral (HIV/AIDS), anti-bacterial and anti-fungal agents for a variety of applications.   Excerpt  Regarding  UCLA  Studies   UCLA  Test  Results  Support  MDI-­‐P  As  An  Effective  Anti-­‐Bacterial  Agent   Tapping  first  into  the  sterilization  and  veterinary  treatment  industries,  Medical  Discoveries  intends  to   generate  cash  flow  in  the  near  term  to  fund  the  commercialization  of  MDI-­‐P  as  a  broad-­‐spectrum   anti-­‐bacterial  agent.  “There  is  an  urgent  need  to  find  new  anti-­‐  bacterial  agents  that  are  effective   against  multiple  drug-­‐resistant  bacteria  and  against  new,  emerging  infections,”  states  P.B.  Fernandes,   Vice  President  of  biomolecular  screening  and  drug  discovery  at  Bristol-­‐Myers  Squibb  Pharmaceutical   Research  Institute.  According  to  Fernandes,  the  antibacterial  market  is  significant  with  yearly  global   sales  estimated  at  over  $20  billion.   A  series  of  preliminary  studies  were  completed  in  April  evaluating  MDI-­‐P  as  a  potential  broad-­‐ spectrum  anti-­‐bacterial  agent.    Conducted  at  the  UCLA  (University  of  California,  Los  Angeles)  Clinical   Microbiology  Laboratory,  the  studies  successfully  demonstrated  the  ability  of  MDI-­‐P  to  eliminate  in   vitro  (outside  the  human  body)  several  types  of  antibiotic  resistant  bacteria,  including  Staphylococcus   aureus,  E.  coli,  and  Enterocooccus  faecalis,  the  three  most  common  causes  of  hospital-­‐  acquired   bacterial  infections.  The  next  step  for  MDI  is  to  complete  in  vivo  testing  per  FDA-­‐recommended   criteria,  enabling  the  company  to  market  its  product  within  the  United  States.   “The  results  of  the  UCLA  studies  have  helped  to  materially  enhance  the  potential  of  MDI-­‐P  as  a   revolutionary  antibacterial  agent  for  many  emerging  bacterial  juggernauts,”  says  Zidell.  “We  look   forward  to  completing  the  testing  phase  for  MDI-­‐P  as  a  bactericide  and  intend  to  translate  the   significance  of  these  results  into  bottom-­‐line  success  over  the  long  term.”  He  also  indicates  that  the   results  of  the  studies  also  form  a  basis  for  understanding  the  mechanistic  action  of  MDI-­‐P  and  will  be   included  in  the  company’s  IND  (Investigational  New  Drug)  submission  to  the  Food  and  Drug   Administration  for  MDI-­‐P’s  application  as  an  HIV/AIDS  therapy.