TolerRx Initiates Three Clinical Trials in Autoimmune Indications

[Guest guest]

TolerRx Initiates Three Clinical Trials in Autoimmune Indications

CAMBRIDGE, Mass., Dec. 7 /PRNewswire/ -- TolerRx, Inc. announced

today the

initiation of three new clinical trials: a follow-on study of its lead

product, TRX4, in subjects with Type 1 Diabetes; a Phase Ib study of

TRX4 in

subjects with moderate to severe psoriasis; and a Phase Ib study of

TRX1,

which is being developed in collaboration with Genentech, Inc., in

subjects

with refractory Cutaneous Lupus Erythematosus (CLE).

In a study of new-onset Type 1 diabetics published in the June

23, 2005,

issue of the New England Journal of Medicine, TRX4 preserved the

function of

insulin-producing beta cells in the pancreas and reduced the amount of

administered insulin needed to control blood glucose levels for at

least 18

months after a single six day course of therapy. With clinical proof of

concept established, TolerRx has initiated a follow-on study in the

U.S. in

subjects with new-onset Type 1 Diabetes utilizing multiple escalating

doses in

order to optimize and select a TRX4 regimen to be used in later phase

trials.

TolerRx completed a Phase Ia clinical trial of TRX4 in subjects

with

moderate to severe psoriasis in which the safety and pharmacokinetic

profile

of TRX4 after escalating single intravenous infusions was

established. No

unpredictable adverse events were observed, and maximally tolerated

doses were

defined by cytokine release symptoms. Although the trial was not

designed to

assess efficacy, preliminary results demonstrated clinically meaningful

improvements in several subjects' skin as measured by psoriasis area and

severity index scores (PASI; a composite measure of erythema,

induration,

desquamation and body surface area affected) after just single doses

of TRX4.

Based on these results, TolerRx has initiated a Phase Ib study of

TRX4 that

will evaluate the safety and efficacy of escalating multiple doses in

subjects

with moderate to severe psoriasis.

In addition, TolerRx announced the initiation of a Phase Ib

trial of TRX1

in subjects with refractory CLE. In preclinical studies, TRX1

therapy has

been shown to induce long-term, antigen-specific tolerance without

compromising normal immune function. TolerRx has completed a Phase

Ia single

dose safety study in healthy volunteers, and the current trial will

evaluate

the safety and efficacy of multiple escalating doses of TRX1. TRX1 is a

humanized antibody the company is developing in collaboration with

Genentech,

Inc.

" I am excited about the initiation of these clinical trials and the

opportunity these products may represent for patients. We are

evaluating the

safety, efficacy, and immunoregulatory properties of TRX4 and TRX1 in

disease

indications in which there is either no approved therapy (beta cell

preservation in diabetes mellitus) or there is a need for additional

effective

treatments (chronic plaque psoriasis and CLE), particularly for those

patients

who have failed standard treatment options. TRX4 and TRX1 may have the

potential to provide a long-term benefit after only a short course of

therapy,

something that both physicians and patients would welcome, " stated Lou

Vaickus, Chief Medical Officer at TolerRx.

" The initiation of these three clinical trials demonstrates our

commitment

and ability to rapidly execute our development strategy and provides

promise

to both our patients and shareholders, " added J. Ringler,

President

and CEO of TolerRx. " We are looking forward to completing enrollment

in these

trials and will strive to advance both TRX4 and TRX1 towards market

approval. "

About TRX4

TRX4 is a monoclonal antibody that binds to a receptor found on

all mature

T cells called CD3, which is involved in normal T cell signaling.

TRX4 is

believed to inhibit the function of autoreactive T cells, which are

important

in propagating autoimmune diseases, such as Type 1 Diabetes and

psoriasis,

while inducing regulatory T cell pathways that promote immunological

tolerance

and inhibit autoreactive disease activity. TolerRx is currently

enrolling

subjects with Type 1 Diabetes to participate in a clinical study of

TRX4 in

the U.S. In addition, TolerRx is enrolling subjects with moderate to

severe

psoriasis to participate in a Phase Ib study of TRX4.

About TRX1

TRX1 is a humanized antibody that binds to the CD4 receptor

found on a

subset of T cells. In preclinical studies, TRX1 therapy has been

shown to

induce long-term, antigen-specific tolerance without compromising normal

immune function. TRX1 is being developed for the potential treatment of

autoimmune diseases in collaboration with Genentech, Inc. TolerRx has

completed a Phase I trial of TRX1 and is currently enrolling subjects

with

refractory cutaneous lupus erythematosus to participate in a Phase Ib

study.

About TolerRx

TolerRx is a biopharmaceutical company specializing in the

discovery,

development, and commercialization of novel therapies to treat

patients with

immune-mediated diseases. TolerRx's has two antibodies in clinical

development: TRX4 in Type 1 Diabetes and psoriasis, and TRX1 in

cutaneous

lupus erythematosus (CLE). TRX1 is a humanized anti-CD4 antibody,

which is

being developed in collaboration with Genentech, Inc. TRX4 is an

anti-CD3

monoclonal antibody to which TolerRx owns exclusive rights. TolerRx

is also

developing new products to induce immunological tolerance for the

treatment of

autoimmune diseases and to remove tolerance for the treatment of

cancer or

chronic viral diseases. For more information, please visit

http://www.tolerrx.com.

CONTACT:

TolerRx, Inc.

J. Ringler

Chief Executive Officer

1-617-452-1300

dringler@...

SOURCE TolerRx, Inc.

Web Site: http://www.tolerrx.com

http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104 & STORY=/www/

story/12-07-2005/0004229425 & EDATE=