Some more food for thought from the latest 10K:
OVERVIEW
AutoImmune Inc. (the "Company" or "AutoImmune") is a biopharmaceutical
company developing a new class of orally administered pharmaceutical products
for the treatment of autoimmune and other cell-mediated inflammatory diseases
and conditions. The Company is conducting clinical trials for the following
products: Myloral(R), for the treatment of multiple sclerosis ("MS"),
Colloral(R), for the treatment of rheumatoid arthritis, and AI 502, for the
treatment of chronic transplant rejection. A fourth product, AI 401, for the
treatment of Type I diabetes, is in Phase II clinical trials funded by the
Company's collaborator, Eli Lilly and Company ("Lilly") and the National
Institutes of Health ("NIH"). The Company believes, based on preclinical and
clinical data, that its proprietary approach to therapy can induce tissue-
specific immunosuppression without toxicity or significant side effects.
Additional clinical and commercial advantages of this approach include the
ability to administer products orally (the preferred method of treating chronic
diseases) and the potential for application to a variety of inflammatory
diseases and conditions.
All of the Company's products are based upon the principles of oral
tolerance. Oral tolerance utilizes natural immune system mechanisms associated
with the gut (the small intestine). These mechanisms allow the body to accept
orally ingested proteins by suppressing the immune response that would otherwise
arise against a foreign substance. This suppression can be directed toward a
tissue under attack by the body's own immune system, which occurs in an
autoimmune disease, through appropriate selection and dosing of the protein in
an orally delivered product.
AutoImmune believes it is the leading company developing pharmaceutical
products based upon the principles of oral tolerance. The status of each of
AutoImmune's principal products is as follows:
Myloral----AutoImmune is conducting a two-year Phase III pivotal multi-
center trial in over 500 patients to investigate the use of Myloral in treating
MS. Enrollment in the trial concluded in March 1995 and the last patient visit
is expected to occur in late March 1997. The primary endpoint is the reduction
in frequency of attacks in relapsing/remitting MS. This Phase III trial follows
the conclusion of a 30-patient double-blind Phase I/II trial that showed
positive results. The Company is also conducting a 32-patient human immunology
study to identify biochemical markers that may help guide treatment with
Myloral. In July 1996, researchers at The Brigham and Women's Hospital reported
studies which demonstrated that white blood cells from multiple sclerosis
patients receiving Myloral produce immune-regulating hormones that may suppress
their disease. These studies, which involved 34 MS patients, are the first to
demonstrate the cellular mechanism of oral tolerance in humans.
Colloral----To date, AutoImmune has completed four human clinical
trials of Colloral in over 350 patients to investigate its use in treating
rheumatoid arthritis. In 1996, the Company initiated three additional Phase II
trials, involving more than 800 patients, which were designed to further refine
dosage using material produced by the Company's manufacturing process and to
gather additional data for use in designing Phase III trials. Preliminary
results of these trials are expected to be announced in the second quarter of
1997. In July 1995, the Company announced the results of its Phase II dose
ranging clinical trial involving 274 patients with severe, active rheumatoid
arthritis. The data showed that patients receiving a 20 microgram dose of
Colloral demonstrated statistically significant improvement compared to patients
receiving placebo as measured by the Paulus criteria, a commonly used method to
discriminate between drug and placebo response in rheumatoid arthritis trials.
Colloral was safe and well tolerated by patients at all dose levels.
AI 401---- In December 1994, the Company entered into a collaborative
agreement with Lilly under which Lilly will be responsible for all development,
commercialization and manufacturing of the Company's autoimmune-mediated (Type
I) diabetes products. AutoImmune will receive payments based on milestones
achieved, as well as royalties based on sales. During 1996, Lilly initiated the
first of several Phase II clinical trials to demonstrate human proof of
principle for AI 401. The first study is a one-year, double-blind, placebo-
controlled trial of 300 patients. In addition, Lilly is providing the oral
product for the Diabetes Prevention Trial (DPT-1) being conducted by the NIH.
This trial, which is expected to enroll 490 patients, is designed to determine
whether AI 401 can delay or prevent the clinical onset of Type I diabetes.
AI 502--- In January 1997, the Company initiated a clinical trial of
tolerizing peptides for the prevention of organ transplant rejection. The open
label study, which is being conducted in 15 patients at The Brigham and Women's
Hospital, is designed to assess the safety and immunological effects of oral
peptides in laboratory measures of transplant rejection. The results of this
trial are expected during 1998.
AI 301----The Company is developing AI 301, a recombinant human
protein, for the treatment of uveitis, an inflammatory disease of the eye. Using
its first generation product based on animal protein, AI 300, the Company
conducted a Phase I/II clinical trial in 45 patients in conjunction with the
National Eye Institute of the NIH. Preliminary results of the trial, which
concluded in the first quarter of 1996, were encouraging but did not reach
statistical significance for the clinical
-2-
endpoint. The results of the trial are expected to be published in the American
Journal of Ophthalmology during the second quarter of 1997. The Company expects
that future clinical trials for uveitis will use AI 301, due to the expected
lower cost of manufacturing its recombinant product compared to its product
based on animal protein. |
