Philip Morris
Business Description Hem Research, Inc.
Fields
- Type
- REPT, REPORT, OTHER
- Site
- N28
- Named Organization
- Abbott Lab Intl
- Abbott Universal
- American Foundation for Aids Research
- American Medical Intl
- Americare Health
- Ampliferon Associates
- Boeing
- Bourgeois Fils
- Carter Tso
- Columbia Univ
- Crossroads Health Plan of Nj Baord of Di
- Dechert Price
- Duke Univ
- Dupont
- Ei Dupont De Nemours
- FDA, Food and Drug Administration
- Finance Comm
- Gd Searle
- George Wa Univ
- Hahnemann Univ
- Hainley Sales
- Hca Medical Research
- Hem Associates
- Hem Research
- Hem Research Board of Directors
- Hem Sub
- Hoffmann La Roche
- Hospital Corp of America
- Hospital Corp of America Health Services
- Hzi Lab
- Icp
- Inst for Cancer + Blood Diseases
- Inst for Clinical Pharmacology
- Inst for Immunological Disorders
- Johns Hopkins Univ
- Johnson Johnson
- Magliero Mchaney
- Merck
- Mitsubishi
- Mueller + Co
- Nestle
- NIH, Natl Inst of Health
- Ortho Pharmaceutical
- Peat Marwick
- Pl Pharmacia
- Rodion Forman
- Rohm Haas
- Schering Plough
- Shankman Management Corp of Ny
- Smithkline
- Synthelabo
- Univ Chicago
- Univ of Toronto
- Univ of Tx
- US Patent Office
- Usda, U.S. Dept of Agriculture
- Vanderbilt Univ
- Warner Lambert Intl
- Document File
- 2024986968/2024987027/Hem Resources
- Litigation
- Stmn/Produced
- Named Person
- Brick, I.
- Carter, W.A.
- Hainley, B.T.
- Johansson, N.E.
- Mitchell
- Mitchell, W.M.
- Montefiori
- Pierce, Jbl
- Power, R.G.
- Robinson
- Rodino, P.W.
- Salmon, H.W.
- Shankman, L.I.
- Urdanoff, R.
- Williams, R.D.
- Area
- LEGAL DEPT/CARLSTADT
- Request
- Stmn/R1-004
- Date Loaded
- 05 Jun 1998
- UCSF Legacy ID
- jey46e00
Document Images
BIJS'II+7ESS' DESCRIPTION
HEM RESEARCH, INC.
SUMMARY
HEM:R'esearch, Inc. intends to commerciially develop a number of its
huma n andl ag,ricultural' pharmaceutical products as it moves to
establish iltself as the next major pharmaceutical' company. The
C'ompany ha~s already completed a number of, steps which.position it
for the fast growth necessary to achieve this goal. These steps
include the establishment of the Company as the leader iin AIDS
therapeutic research and'the deveopmen.t of a collaborationiwith a
major pharmaceutical concern.
This business diescriptio~n has been developed in order to assist
the Company in raising the vast financial resources necesisary for
it to compete in the pharmaceutical research/'biotechnology
industry. This description is being provided for informatilonal
purposes only, dioes not purport to bie co.mpliete, and, in no way,
represents an offering, of the C'ompany's securities to any
individual or organization, publicly or privately. Additional
informati'on coincerniing thie Company or issues raised' ini this
description may be obtained by contactin!g Mr. Roy Urdanoff at
(301) 770-5700.
TABLE OF CONTENTS
PAGE
The Company . . . . .. . . . . . . .. .. . . . .. . . .. 1
II. Use of Proceeds .
I I I . Industry . . . . . . . . . . . . . . . . . . . . . 4
IV. Product.s and'Technology . . . . . . . . . . . . . . 9
V. Opera tions . . . . . . . . . . . . . . . . . . . 18
VI. History . . . . . . . . . . . . . . . . . . . . . . 24
VII. Ma nageme nt . . . . . . . . . . . . . . . . . . . . 26
VIII. Financial Statements . . .. . . . . . . . . . . . . 2'9

I. THE COMPANY
HEM Research, Znc. ("HEMR'esearch" or the "'Company" ), intends to
develop, manufacture, market and/or license human and aaricultural
therapeutic and' diagnostic pharmaceutical products based onithe
use of its proprietary technologies. The Company''s development
efforts primarily focus around a class of biologi!cals known as
mismaitched double-stranded ribonucleic acids ('"dsRNA''s" )1. These
compounds work by stimuliating the body's natural defense system,
.
including the induction of various lymiphoki~nes, such as interferon
and interleuken, as well as through t'he completion of' certain
biological pathways critical to immune function. The Compainy
holds all patent and license rights to this class of products
through its~dievelopment of a broad patent portfolio.
HEM Research has pioneered an, approach of "systems management"' to
the development of pharmaceutical products. This approach enables
the Company to develop its. products by utiliz~inig various
relationships it has with subcontractors, corporate partners,
academic institutions and governmental agencies. These
relationships allow the Company to: (i) maintali!n the rights to
all its products by building a large patent portfolio in thee
relevant areas7 ('ii) promptly evaluate and take advantage of its
clinical opportunities; (iii) reduce costs and increase
operational efficiencies; and (iv)' insure thie integrity andl
quality of the Company and its development efforts.
The Company's first dsR'MA product, given the trademark name
Ampligien, has been under development since 198'01. The NIH have
contributed or committedi more than $20 million to this prograim.
Ampligen has been used in human clinical trials since 198!4. It is
currently being tested on acquired immune deficiency syndrome
('"AIDS") patients, AIDS!-related complex ("ARC") patients and',
cancer patients. The Company expects to complete a series of
double-blind, placebo studies on approximately 200 ARC patients
this year and on a similar number of AIDS patients 'soon after.
The Company intends to enter into a collaboration with E. I. du
Pont de Nemours and Co., Inc. ("Du Pont") to further the develop-
ment of dsRNA's. U'nder the proposed terms of this agreement, Du
Pont will contribute cash andllaboratory testing, manufacturingg
process diesign, and'other "in-kind" services for al nominal equity
position in the Company as well as.a rig;ht of'first refusal to
acquire th~e commercial development, manufacturing, and' marketing
rights to all existing and future products and technology in the
fiel'd of use of dsRNA's.
The Company has also aggressively filed for patents in areas
outside of the use of dsRNA's as therapies for human disease.
These areas include (ii) diagnostic testi!ng of immune deficiency
and dysfunction; (ii) combinational therapies of various
lymphokines and'dsRNA's; (iii) interferon and interferon-indtrcers
to eliminate the toxilcities of tobacco; (i~v) plant protection from
pathogens; (v) stabilizationiand purification of interferon; and
(vij a method' of producing plasminogen activator (blood' thinner).

II. USE OF PROCEEDS
Th~e net proceeds from an offeriing of the Company's securities willl
be addedl to the Company's general corporate funds. The Company
intends to use these proceeds for further research and~ development
activilties a:nd general corporate purposes~, as given below:.
1. Development of improved formulation and delivery
method for Ampligen admi!nistration . . . . . . . $ 10,0100,000
2. Maufacturing process development - large-scale
dsRNA production . . . . . . . . . . . . . . . . 15,000,000
3. Additional cllini'cal studiies~ for Amipligen as a
stand-a1lone therapy or as part of a combinational
therapy for AIDS/AR'C:
(ai)' 200 patient double-blind placebo phase III
study of AIDS (United States) . . . . . . .
(b)i 200 patient double-blind placebo phase III
study of asymiptomatic I3IV-iinfection (United
States) ... . . . . . . .. . . . . . . . . .
Phase I/II and II/III studies~on combina-
tional Ampli'igen/AZT therapy for advanced
AIDS patients (United States) . . . . . . .
(d) Overseas phase I/II/III studies - Western
Europe and Japani(assist'ance from collabor-
ating organizati~ons) . . . . . . . . . . .
5',000,000
10,000,000,
10,000,0'00
20,000~,000
4. Other clini~cal studies:
(a) Phase III double-blind'placebo study for
Am!pligen as standi-alone therapy for renal
cancer (United~ S'tates), . . . . . . . . . . 5',0i00,0100
(b), Phase II/III double-blind pliaceboistudy forr
combinational Ampligen-interferon therapy
for chronic myelogenic leukemia (United'
S'tates) . . . . . . . . . . . . . . . . . . 5,00'0,000
Phase I/II studlies of Amplig,en as therapy for
(i)' multiple sclerosis; (ii) inflammatory
arthriti'des; (iii), Alzh!eimer"s disease; (!iv)
lung cancer; ('v) breast cancer; (viij mellanoma
(Unitedi S'tates) . . . . . . . . . . . . . . 10,000,000.
5. 0'ther research andi development:
(a) P'reclinical program in tobacco detoxificationi,
i~ncludingi animal testing and dsRNA inclusion
in tobacco . .. . . . . . . . . . . . . . .. 1.000,000
(b) Expansi=of plant protection research
programs . . . . . .. . . . . . . . . . . . 1,0'001,000
(c), Preclilnicaill studies onpZasminogen~ activator,
including toxicology work, animal studies and
manufacturing development .. . . . . . . . . 3,000,00'0
6. Additional' working capital requirements
20,000,000
Total capital required . . . . . . . . . . . . . $115,000,000

The Company iintendis to use approximately $10,000,000 to initiate
and complete a research program to enable an improved techniquee
for introducing Ampli.gen into the body. Current testing programs
use the parenteral' method. The. development of an alternative
delivery technique, such as a nasal spray, or evenian intra-
muscular injection, will enable th~e Company to eliminate the cost
and inconvenience of a hospital' IV procedure to patients using, its
dsRN'A products.
C'oncurrently, the Company' plans to s'tart' a$15,0010,000 devel'opment
program to further reduce production costs and to increase
processing capacities. See "V. Operations - Nianufacturing."
As discussed in "V. Operati!ons", th~e C'ompany plans to launch a
major R&D effort desig,ned to determine and capitalize on its
current product opportunities. It plans to spend approximately
$65,000,000 in different areas. The Company's AIDS/ARC clinicall
initiative will require $45,000,000, so that the Company, in
addition to the ARC program it has underway, may commence with the
fol'lowing, studies: ('i) a 200 patient double-blindi placebo study
for pati'ents withl advanced' AIDS at the same three treatment
centers; (ii) a; similar 200 patient double-blind placebo study forr
patients~~ with asymiptomaitic HIV-infection; (iii ) a study similar to
(i) except that it examines a combinational therapy of AZ'T' and
Ampliigen on advanced AIDS' pati'e,nts; and' (iv) various international
clinical programs necessary for world-wide commercialization of
dsRNA as a treatment for AIDS, ARC and asymptomatic HIV infection.
Approximately $20,000,000 will also be needed to continue the
Company's extensive work in cancer therapy. The Company plains a
phase III double-bLindl study on approximately 100 renal cancer
patients using Ampligen as a stand-alone therapy and a 20'0 patient
phase II/III study of chronic myelogenic leukemia using a
combination!al protocol of interferon and' Am!pligen. Additionally,
the Company irnten~d's to begini phase I studies using Amplilgen and
other dsRNA products as treatments for lung cancer, breast cancer,
melanoma, multipl'e sclerosis, inflammatory arthritides, and
Alzheimer's disease.
The other products includ'ed' in the Compamy's~patent portfolio,
tobacco~ dietoxification, plant protection from pathog,ens, and a new
human. blood th°inner, will require approximately $5,000,000 to
begin development.
The balance of th~e proceeds of this offering, will be used'o
to
finance anticipated operating losses and to increase cash balances
available for generaL corporate purposes, such as financing,
marketing, manufacturing andilicensing, activities as well as other
research and developme,nt efforts~not presently envisioned by the
Company. The Company anticipates creating, positive cash flow
within the first twelve months following this offering through the
successful complietiom, of its AIDS c1!inicall initiative. After that
time the Company plans to use any cash generated from operation,
in addition to capital! raised i!n future offerings of iits
securities, to continue its research, and development activities.

III. INDUSTFt'I''
BA1CF+.GFt'[.)UND
The functi'on of the immune system is to protect the body against
infectious agents, iincluding viruses, bacteria, parasites and
malignant (cancer) ce1'ls. An iind,ivi:dual"s ability to respond to
infectious agents and other substances recognized'as foreign by
the body's immune system (antigens) is critilcal to heal!th and
survival. When the immune response ils adequate, infection is
usually combatted effectively and recovery follows. Severe
infection can occur when the immune response is inadequate. Such
immune deficiency occurs congenitally, but more frequently is
associaited with intense siickness or treatment withc chemothera-
peuitic drugs or radiationi. In recent years, infection by an
unusual virus (HIV) has been known to cause a serious andiofteni
fatal disease cail!led acquired immune deficiency syndrome (AIDS).
There are also a variety of'medical conditions i.n which.excessive
or iinappropriate immune function apparently plays~ a rol'e or causes~
adverse reactionsagainst body tissues.. These include rheumatoid
arthritus andi Type I diabetes miellitus.
It has been known for many years that the immune system is
responsible for defending the body against, disea~ses throughi the
generation of antibodies produced by natural i~nfection or
immunization with vaccines. But it is nowknown that antibody
production is only one.aspect of the immune system. There is a
second type of immune mechanism which is orchestrated through the
action of certain specialized! white bloodl cel!ls, foundi i~n the
blood, spleen, lymph nodes and certain other organs. Two classes
of white blood cells, macrophages and'1!ymphlocytes, are primaril!y
responsibl'e for this second type of immunity, which is,referredi to
as ce1Z-medicated'i immunity.
Under normal circumstances, the cell-mediated immune system serves
severale important functions. First, the cell-mediated immune
system~ is responsible for the ability of on~e individual to
recognize another individual's tissues as foreign, and is: thus the
principal barrier to, tissue or organ transplantion. Second, in
response to infection or neoplaistic disease, specialized cells
become activated to e.ither directly kill foreign organisms or to
lyse infected ce1'ls or cancer ceLls. For certain diseases, such
as tuberculosis and leprosy, this represents the principal
mechanism by whichithe body resists infection. Finally, the cell-
mediated immune system al!so serves~ an important hellper function in
allowingi for the production of specific antibodies against
bacteria, viruses and other foreign agents.
Un~der certain, other, aibnormal circumstances, however, the cell-
mediated immune system, fails to function properly, actually
contributing to the development of disease. This, includes
instances where the immune system actually reacts inappropriately
against the body''s own tissues (treating, them as though they were
antig,ens), a phenomenon knownias autoimmunity, which is observed
in rheumatoid arthritus, systemic lupus erythematosus, and Type I
diabetes mellitus. Additionally, patients with.advancedicancer or

chronic infections, the aged, and indi'viduals with AIDS display a
general reduction in the efficiency of' the cell-mediated immune
system which renders them susceptible to infection by agents whiich
do not normally affect younger ind'ividual's.
The interpliay among, the white blood cellis that constitute the
cell-mediated immune system determines, to a large part, the
strength and breadth of the body's response to infection. It is
generally believed that the activities of these immune celils are
controlled to a, large extent by a specific group of hormones
caillled lymphokines. Lymphokines regulate the many and'd
varied
aspects of the immune response by controlling th~e growth and
maturation of blood cel'ls., including B-cells and T-cell's, and of
other lymphoki'nes. They are produced predominantly by a subset of
human lymphocytes known as helper or T4 cel'ls. Patients suffering
from HI'V'infection show a significantly reduced level of T4 cells
present in their bl.oodstream..
The mai!n approach to date to developing immunological therapies
has been to produce single kinds of lymphokines and to assess
their laboratory and clinical activity. Substantial quantities of
certain lymphokines may be produced by recombinant DNA and cell-
fusion technolog,ies (genetic engineering, techn~iques), which allows
a, cost-effective strategy for the prodluctioniof large amounts of
lymphokine proteins. C1!inical studies designed to eval'uiate the
efficacy of administering doses of'puri'f'ied single lymphokines to
patients suffering from a variety of diseases have beemundertaken
for certain single lymphokines and others are now being planned.
Among the lymphiokines tested thus far are the interferons,
interleuken-1 and' interleuken-2. Many organizations have beguni
th~e development of lymphiokines, and one single lymphokine, alpha
interferon, has been approved for commercial sale to patients.
A second approach developed to assist the immune systemii'n
fightingi viral inf'ectio~n is to identify antiiviral agents with
specific activity against a selectedivirus. This technique has
been particularly common in the search for treatments for HIV-
infected patients. This search has produced several low molecular
weight compounds which,, in preclinical "in vitro" models predicted
significant activilty against the HIV virus. Clinical studies of
such compounds are in progress, and the search for other anti-
virals is continuing. Recently, one compound, Azidothymidine, was
approved for a commercial license by the FDA.
GOVERNMENT RECL'JLATION
The activities of the pharmaceutical industry i'nvolve a field i~n.
which regulation by federal and other governmental authorities is
a significant factor. This regulation applies to the research!and
development and to the manufacturing an~d marketing of any products
developed for sale as a pharmaceutical prod'uct. Present research
activities are subjiect to regulation by certain federal and state
administrative bodies. The Company ii s complying with the
regulations of these bodiles..
The manufacturiing and marketing of pharmaceutical products

requires the approval of the FDA and comparable agencies in
foreigni countries. The FDA has established mandatory procedures
and safety standards which apply to the cl'.inical testing;,manufacture and marketing of
pharmaceutiical products. The process
of obtalining, FDA approval for a new therapeutic compound may take
several years and often involves the expenditure of substantiall
resources. The steps required'before a human pharmaceutical can
be produced and marketed include precli'nicali studies, the filing
of an Investigiational New Drug ("IND," ) appl'ication, human clinicall
trials and the approval of an application for a License.dl
Biological or a New Drug Application ("NDA")..
Preclinical studies are conducted in the laboratory and in animal
model' systems to gain preliminary information on the drug's
efficacy and to identify major safety problems. The resul'.ts of
these stu!dies are submitted'o to the FDA as part of the IND appli-
cation before approval can be obtained for the commencement of
testing in! humans.
The human clinical testing program required for a new pharma-
ceutical product involves three phases. Phase I'studies are
conducted on volunteers or, iin the case of antitumor or antiviral
agents, onipatients with terminal disease at anialdvanced stage of
the di'sease, to determine the maximum tolerated.dose and any sidee
effects of the substance. Phase II stuldiies are conducted on
patients having a; specific disease in order to determine the
substance's efficacy and the most effective dbses andl schedules of
administration:. Phase III involves wide-scale studies on patients
with the same disease in, order to provide comparison with
currently available drugs or biologics. Data from Phase I, II and
III trials are submitted in an NDA or application for a Licensed
Biological. Preparation of an NIDA involves considerable data:
collection, verificatilon and analysis, as well as the preparationi
of summaries of the manufacturing and testingi pxocesses, pre-
clinical studiles, and clinical tri'als. T'he FDA must appro e the
NDA before the applicant may market a, human therapeutic product.
The FDA may also elect to give the product a cond'itional' approval
for commercial' sale. In such an instance, studies must be contin-
ued on patients after the commercial approval is. given. At the
end of the extend~ed trial period, termed a Phase IV test, the drug,
is reevaluated and a final decision regarding approval for
commercial sale is made.
The commercial manufacture and, marketing of agriculturall and'
aini mal health products generally requires approval by the United
States Department of'Agriculture ("'USDA") and, comparable agencies
in foreign countries:. Typically, the USDA requires such products
to be tested on animals. These tests must employ specific
procedures, be produced in USDA-licensed facilities and' exhibit
appropriate level's of efficacy, safety anldl purity. USDA approvalll
procedures, however, are substantially less time-consuming and
less expensive than FDA approval procedures.
The manufacturing, and marketing, of diagnostic products requires
compliance with; regulations which, g,eneral'ly, are less dif'ficul't

to comply wi'th than are those coveringi pharmaceuticals.
In, add'ition to: approval for the commercial salle of ai pharma-
ceutical product, aporoval must also be obtained'iin order to
manufacture a pharmaceutical or biological. This process invol'ves
determining the aibili ty of a: specific manufacturer to;produce
quantities within defined product specifications across a, number
of production lots over a period of time. Once th~e FDA is able to
establish that the compound is reprodbicable, a manufacturing
license may be granted.
B'ecause of the 1'arge amount of research and development studies,
cl'inical data, and regulatory approvaLs required, it is now
estimated thalt the successful development of a pharmaceutical
product may cost up to $100' million andl take several years too
ach~ieve.
COMPETITION
This segment of the pharmaceutical industry is a rapidly expanding
area of biotechnology iin which research and development of immuno-
logical therapeutic and diaginostic products is. being conducted by
public and private foundations, governmental institutions, major
pharmaceuticaL companies and biotechnology compani'es in the Unitedi
States and certain foreign countries~.. Competition in the industry
is based on, pace of research and clinical' testing, acquiring
patents , and, developing manufacturing technology. A number of
large, well-established pharmaceutical' compainies are currently
working on a variety of therapeutic and diagnostic products that
are in: various stages of development and clinicall, testing. In
addition, several biotechnology companies with a focus on immuno-
logy have been formediin recent years. Many of these companies
have entered into licensing and other collaboraitive arraingements
with commercial companies or governmental or non-profit institu-
tions to fund researchi&nd development and manufacture and market
resulting products.
There are three predominant classes of products being develioped
for the treatment of' cancer and'viral diseases. The first class,
referred to as diagnostics, consists of monoclonal antibodies usedl
to fight diseased cells and are used initreatingicancer. Another
group, called therapeuti~cs, employs recombinant DNA technology,
includes interferons and initerleukens, ands is beiing studied in
both antiviral and cancer appLicati'ons. A third class of products
beingactiveLy investigated are low molecular weight chemical
compounds which theoretically have significant antiviral activity.
Monoclonal Antibodies are used in diagnosing cancers and certai'n
viral diseases, and have been very effective in producing accurate
disease and/or dysfunction determinations~. Recently, these drugs
have ailso been tested as treatments for a, number of the diseases
they are used to diagnose. By affixing poisons to these
antibodies, it is hoped that the antibodi'es will' attach themselves
to diseased ce1ls andi administer the affixed poison to destroy the
diseased cell. The danger in this form of treatment ils that the
antibodies will instead~ attach themsle"ves to healthy, critical-to-

life cells and destroy the patient rather than the disease.
Consequently, this treatment may be highly toxic. Resu~lts to date
have not indi~cated great success, and therefore the mer3ical'
community is moving cautiously with this.approach.
The therapeutic drvg,s are synthetic pror3uctions, usilng recombinant
DNA technology, of the natural protei~ns manufactured by the immunee
system and include bothiinterferons andi interleukens. Each drugi
represents a single lymphokine. Many of the factors have not been,
identifiedl and/or successful'ly synthesized! to, date. They also do
not exhibit certain characteristics necessary to activate some
immune factors or to complete other biological pathways necessary
for proper i!mmune function. Therapeutics are disease-speci~fic and
are thus elected for use iin th~e treatment of certain diseases.
These compounds have shown a remarkable cure rate for certain rare
forms of leukemia; however, they have not producedla satisfactory
performance in treating most other cancers and viral diseases.
Also, because treatment requires creating abnormally high concen-
trations of the drug in the body, therapeutics can exhibit a high
degree of toxici'ty. These drugs have enjoyed significant commer-
cial support due to both their perceived'. potentia~l' and the lack of
effective treatments for many cancers and vi'ral'' diseases.
Low molecular weight compound's have received a great deal of'f
attention, recently in the effort to combat the threat of AIDS.
Preclinical artificial ini vitro models pred!icted' significant anti-
HIV gictivity. Because, of this anticipated antiviral activity,
products such as AZT (azi'dothymidine) and ribavariin were quickly
tested in large double-blind trials. Ulnfortunately, clinical
results of these trails have shown only limitedl eff'i~cacy for these
compound's as treatments against the HIi/ virus.
Other approaches being used to develop products for the treatment
of' cancers and viru~ses incl'ude the use of "immunomodulatory"
drugs. These drugs are suiggested to be capable of stimulating the
production of a number of'lymphokines by the immune system. This
methodl of' stimulating immune respornse is a more natural approxi-
mation of the normal immune process and is expected to be more
effective in correcti'ng, immune deficiencies and diysfunction.

IY. PRODUCTS ANIIDiT'EC'HNOD©GY
Products and technologies patented and'currently under development
bv HIHM R'eseairch, Inc. include:
1. Mismatched double stranded ribonucleic acids (dsRNA's)
for the preventi on and treatment of AIDS/ARC, various
caincers, chronic hepatitis, herpes, Alzheimer's disease,,
multiple sclerosis, inflammatory arthritides and other
indications.
2. Combinational therapies empLoying various silngle lympho-
kinies and dsRNA's for the treatment. andprevention of
various human diseases and infections.
3. Combinational therapies of reverse transcriptase inhi-
bitors aind dsRNiA's inithe prevention and treatment of
certain viral i!nfections..
4. Diagnostic testing of individlual's and "ait-risJc" popula-
tions with respect to the HIV virus.
Non-toxic additives and treatment processes to detoxify
tobacco.
6. Non-toxi!c additives to provide broad spectrum plant
protection from pathogens.
7. Storage medium for thie stabilization and purification of
interferons..
Process to produce plasminogen activator (blood
thinner).
Mismatched Double-Stranded Ribonucleic Acids
The Company"s dsRNA prod!ucts may be classified as immunomodhlal-
tory compounds. They are distinguished.from other therapeutic
products in that they promote the use of the body's own defense
system to fight infectious agents and disease. They are generally
preventive treatments with potential as therapeutics.
When introduiced into the body, a dsiRNA, as a large nuicleic acid,
will initiate a two step process equivalent to an immune system
repsonse. The comipound appears as a virus to: the human immune
system and thus induces a normal immunie reaction, including the
induction of various white blood cell! activiities and the produc-
tio:n of the appropriate lympho]tines. The reaction approxilmates a
natural immuneresponseinthaittheimmuinefactors~appearat theilr
normal levels of concentration withi!n thie body.
The second step of this process results from the dsRNA chemical
structure. Certain biological pathways which are set in motion,
during immune system reactions requidire the presence of a catalyst
to complete the path!waly. dsRNA's serve that catalyst function.
