Second Phase 2 clinical trial underway this quarter to evaluate

oral deforolimus

CAMBRIDGE, Mass.–(EMWNews)–ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced the

initiation of a randomized, multi-center, Phase 2 clinical trial to

evaluate the safety and efficacy of oral deforolimus, its

investigational mTOR inhibitor, in patients with advanced endometrial

cancer. In collaboration with Merck & Co. Inc., deforolimus is currently

being studied in multiple clinical trials, both alone and in combination

with other therapies, in patients with several different types of

cancer. Under terms of the agreement, ARIAD will receive a $2.5 million

milestone payment from Merck upon treating the first patient in this

clinical study.

The clinical trial will compare single-agent oral deforolimus to

progestin in patients with metastatic or recurrent endometrial cancer

following first line chemotherapy. The primary endpoint for the study is

progression-free survival. Overall survival and response rate will be

evaluated as secondary endpoints. This is the second Phase 2 clinical

trial to begin this quarter examining the safety and efficacy of oral

deforolimus in patients with different solid tumors.

“We have Phase 2 data on the intravenous form

of deforolimus in endometrial cancer and are pleased to now examine the

potential of this drug candidate in its oral form in similar patients

with this cancer,” stated Pierre F. Dodion,

senior vice president and chief medical officer of ARIAD. “There

is significant unmet medical need for the effective treatment of

patients with endometrial cancer, and this controlled clinical study is

designed to help inform us of the potential impact of oral deforolimus

on patients with this difficult-to-treat cancer.”

The clinical trial will enroll 150 patients at approximately 50 sites

including medical centers in North America, Europe, Asia and Australia.

Patients will be randomized (1:1) to oral deforolimus or progestin, a

commonly accepted treatment in patients with endometrial cancer.

Enrollment in the trial is expected to be completed by the second half

of 2009.

“With the start of this trial, we now have

begun enrollment in two Phase 2 clinical trials of oral deforolimus this

quarter,” said Harvey J. Berger, M.D.,

chairman and chief executive officer of ARIAD. “The

start of this study is another important milestone for deforolimus and

for the joint development program with Merck. We are committed to

completing these clinical trials as quickly as possible facilitating the

potential development of deforolimus in multiple cancer indications.”

ARIAD announced the initiation last month of a Phase 2 clinical trial of

deforolimus in patients with advanced breast cancer.

For more information about clinical trials evaluating deforolimus, or to

find a trial site close to you, patients and physicians should call the

US toll-free number 1-877-621-2302 or the international number

1-617-621-2302, or email us at [email protected].

Additional information can also be found at www.ClinicalTrials.gov.

About Endometrial Cancer

Endometrial cancer, which develops from the inner lining of the uterus,

is the most common cancer found in the female reproductive system.

According to the American Cancer Society, about 40,100 new cases of

endometrial cancer will be diagnosed in the United States and

approximately 7,470 women will die from this disease in 2008. Prognosis

for patients is primarily based on the time of diagnosis relative to the

stage of the cancer. Initial treatment consists of surgery alone, or in

combination with radiation, chemotherapy and/or hormonal therapy. For

those women with disease progression, chemotherapy is the only currently

available treatment option, and limited benefit has been seen in such

cases, emphasizing the need for new therapies.

About Deforolimus

ARIAD’s lead product candidate, deforolimus, is a novel rapamycin analog

that specifically and potently inhibits mTOR, a downstream activator of

the PI3K/Akt and nutrient sensing pathways. The mTOR protein acts as a

“master switch” in cancer cells. Blocking mTOR creates a starvation-like

effect in cancer cells by interfering with cell growth, division,

metabolism, and angiogenesis. Multiple Phase 1 and 2 clinical trials of

deforolimus in solid tumors and hematologic cancers have completed

patient enrollment. The global Phase 3 SUCCEED trial of oral deforolimus

in metastatic soft-tissue and bone sarcomas is based on a Special

Protocol Assessment agreed upon by the U.S. Food and Drug

Administration. ARIAD has a global partnership with Merck & Co., Inc. to

develop and commercialize deforolimus, an investigational mTOR

inhibitor, in patients with cancer.

About ARIAD

ARIAD is engaged in the discovery and development of breakthrough

medicines to treat cancer by regulating cell signaling with small

molecules. ARIAD is developing a comprehensive approach to patients with

cancer that addresses the greatest medical need – aggressive and

advanced-stage cancers for which current treatments are inadequate.

ARIAD has a global partnership with Merck & Co., Inc. to develop and

commercialize deforolimus, ARIAD’s lead cancer product candidate, which

is in Phase 3 clinical development. ARIAD’s second oncology product

candidate, oral AP24534, is a novel multi-targeted kinase inhibitor in

Phase 1 clinical development in hematological cancers. ARIAD has an

exclusive license to pioneering technology and patents related to

certain NF-κB treatment methods, and the

discovery and development of drugs to regulate NF-κB

cell-signaling activity, which may be useful in treating certain

diseases. Additional information about ARIAD can be found on the web at http://www.ariad.com.

This press release contains “forward-looking

statements.” Forward-looking statements are

based on management’s expectations and are subject to certain factors,

risks and uncertainties that may cause actual results, outcome of

events, timing and performance to differ materially from those expressed

or implied by such statements. These risks and uncertainties include,

but are not limited to, the costs associated with our research,

development, manufacturing and other activities, the conduct and results

of pre-clinical and clinical studies of our product candidates,

difficulties or delays in obtaining regulatory approvals to market

products resulting from our development efforts, our reliance on our

strategic partners and licensees and other key parties for the

successful development, manufacturing and commercialization of products,

the adequacy of our capital resources and the availability of additional

funding, patent protection and third-party intellectual property claims

relating to our and any partner’s product candidates, the timing, scope,

cost and outcome of legal and patent office proceedings concerning our

NF-κB patent portfolio, the potential

acquisition of or other strategic transaction regarding the minority

stockholders’ interests in our 80%-owned subsidiary, ARIAD Gene

Therapeutics, Inc., future capital needs, risks related to key

employees, markets, economic conditions, prices, reimbursement rates and

competition, and other factors detailed in the Company’s public filings

with the U.S. Securities and Exchange Commission. The information

contained in this press release is believed to be current as of the date

of original issue. The Company does not intend to update any of the

forward-looking statements after the date of this document to conform

these statements to actual results or to changes in the Company’s

expectations, except as required by law.

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