The "Professional Response"
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Posted by Ellen on 07:59:29 2010/03/11
In Reply to:
Scam or Legit Research? posted by Frank Cz.
Thank you for your expression of interest in the treatment of IDD or Type 1 Diabetes. At this point in
time we are only in the very early stages of commercializing the treatment, and depending on which
part of the world you reside, the treatment will not be available to the general public until the end of
the 2010 calendar year. However, to answer some of your questions we have prepared the following:
In Type-I Diabetes, haywire immune cells attack the insulin-making beta cells in the pancreas.
These haywire immune cells are produced by hibernating virus particles found in all Diabetics'
islet cells. This means people with Type-I Diabetes can't make the insulin they need and require
the use of supplemental insulin. The goal of our treatment is to stimulate the islet cells to
express these hibernating virus particles and enable the body to eliminate the cells carrying the
hibernating particles once and for all which rids the body of these "bad" immune cells and
replaces them with low physiological levels of inactive memory cells that can no longer attack
the islet cells - thus stopping beta-cell damage and restoring proper immune function.
The treatment, rather than management, of Type-I Diabetes is an unmet need. As well as
treating current diabetics the technology could target the at-risk portion of the population with
the potential to prevent or delay the onset of the condition. As the treatment utilises a
combination of commonly available pharmaceutical substances it requires less development
than a new chemical entity and the route to market is more reliable and is expected to be
quicker and less costly than for a totally new drug or drugs. Providing a screen to determine if
the treatment is suitable for use on a particular patient reduces unnecessary treatment cost.
Being able to determine when the treatment is effective allows the treatment to be completed
as soon as functioning physiological levels of islet cells have been created.
Pre-Clinical Studies and Clinical Trials were conducted over a number of years:
1987 - 1989 - conducted animal tests
1990 - 1992 - conducted Phase-I studies to determine dosage, toxicity, and protocol
1993 Ethical Committee approval to run Phase-II/III/IV studies
1994 - 1996 Phase-II/III Study on 2000 patients
1997 - 2002 Phase-IV Study on 7000 patients
2003 - 2006 Second Phase-IV study on 6000 patients
The first 1,000 patients were treated between 1990 and 1992. It took three (3) months
to determine the correct dosages. The treatment dosages were increased until the
patients' daily insulin dosages could be reduced consistently in prescribed intervals and
the CD45+ and CD54+ markers returned to homeostatic levels in the laboratory tests.
2
Of the 1,000 patients treated during that period more than 830 are disease free
Of the 2000 patients treated during the 1994 to 1996 study more than 1,650 patients
are disease free
Of the patients treated during the 1997 to 2002 study more than 5,650 patients are
disease free
Of the patients treated during the 2003 to 2006 study more than 4,850 patients are
disease free
Every patient that does not develop a relapse during the first 24 months after treatment
remains disease free
To obtain patients for the study, the German Ministry of Health assisted by sending out
letters to every doctor requesting him/her to refer all his/her IDDs to the nearest
Endocrinology Center
There are three major papers, yet to be published, which form the basis of a Clinical Paper to be
submitted for publication in Nature or a Journal of similar stature once the full patent is in place.
Dec 1996: Berg, P.; von Arnim, C.; Suoman, P.E.; Peotrovsky, A.; and Heyneman, B. - Trial Report of
Randomized Double-Blind, Crossover, Placebo-Controlled Clinical Trial to Determine the Efficacy of BCG
and Famiciclovir to Permanently Eliminate the Need for Insulin in Type 1 Diabetics; Univeristy of Tuebingen
Auf der Morgenstelle, Tubingen.
Dec 2002: Berg, P.; von Arnim, C.; Ager, A; and Piotrovsky, D. - Trial Report of Randomized Double-Blind,
Crossover, Placebo-Controlled Clinical Trial to Determine the Efficacy of BCG, Famiciclovir and Aldara to
Permanently Eliminate the Need for Insulin in Insulin-Dependent Diabetics; Univeristy of Tuebingen Auf
der Morgenstelle, Tubingen; University of Heidelberg Department of Internal Medicine, Heidelberg;
Universitatsklinic Charite, Berlin; Manchester University, Manchester, UK.
Dec 2006: Trial Report of Randomized Double-Blind, Crossover, Placebo-Controlled Clinical Trial to
Determine the Efficacy of BCG and Famiciclovir to Permanently Eliminate the Need for Insulin in Insulin-
Dependent Diabetics; Univeristy of Tuebingen Auf der Morgenstelle, Tubingen; University of Heidelberg
Department of Internal Medicine, Heidelberg; Universitatsklinic Charite, Berlin; Bundesinstitut fur
Arzneimittel und Medizinprodukte Kurt-Georg-Kiesinger Allee 3, Bonn
The system involves the exploitation of High Endothelial Cells (HECs) for research and diagnostic
purposes.
The technique enables the growth and cultivation of specific cell lines while maintaining
their specific and unique morphology longer than 600 days compared to the current
norm of 8 days for this cell culture.
Long-term cultivation allows research goals such as the production of large numbers of
adult stem cells to be met.
Long-term culture also allows the identification and isolation of the factors that control
inflammatory processes.
3
The benefits of the technique are:
i. Highly cost effective production
ii. Simple and easily reproducible production techniques
iii. Low risk of contamination
iv. Simple verification of cell line
v. Stable cell lines
vi. Simple analysis procedures to determine suitability for treatment
vii. Cure of Type-I Diabetes
viii. Potential to develop a cure for Type-II Diabetes
ix. Utilizes a combination of commonly available pharmaceutical substances
This treatment of Type-I Diabetes utilizes a number of active ingredients that have been used in
various disciplines of medicine for a number of years. None of the agents is currently used in the
treatment of Type-I Diabetes. In addition there is a third agent which acts as a catalyst, aiding
the effectiveness of the other agents. The treatment is conducted over 9 12 months and
involves 17 individual combination drug treatments. For each patient dosage of the active
agents are closely monitored through the testing regimen and adjusted according to the results.
The insulin dosages are also monitored and reduced over the length of the treatment.
The active agents are delivered in both injectable and oral formulations and it is hoped that over
a relatively short period of time the delivery will be improved in terms of simplicity and
frequency.
The treatment follows a diagnostic test that establishes the presence and number of damaging
white blood cells. The test can be easily performed by a hospital or private laboratory on referral
by a Specialist Endocrinologist or a General Practitioner. Once the patient is confirmed as being
a suitable candidate, the treatment, which consists of both injectable and oral components, can
commence. It is expected that 90% of all Type 1 Diabetics will be suitable for treatment.
The diagnostic test is used regularly throughout the treatment period to monitor treatment
success by establishing the elimination of damaging white blood cells and the patient's need for
insulin. In this way the Physician can slowly reduce the patient's insulin requirements over time
without putting their health at risk.
The treatment is quite aggressive and side effects may be experienced. However, under medical
supervision these are easily handled and in most cases will not lead to discontinuation of the
treatment. Type 1 Diabetics are very much attuned to daily and in some cases more frequent
dosing of insulin by injection. After the treatment is completed it is expected that 80% of Type 1
Diabetics will be disease free and no longer dependent on insulin. Their overall health will be
much improved and costs associated with maintenance reduced significantly.
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