Curemarkが新自閉症薬の新たな第III相臨床試験の開始を発表

AsiaNet 60447 （0614）

【ライ（米ニューヨーク州）2015年5月11日PRN＝共同通信JBN】株式非公開の医薬品研究開発会社のCuremark LLCは新薬CM-ATの効果を調べるための3歳から8歳の自閉症児を対象にした新たな第III相ダブルブラインド、無作為、偽薬対比臨床試験の開始を発表した。これまでにCuremarkは消化酵素キモトリプシンのレベルが低い3歳から8歳の自閉症児を対象にCM-ATのFDA（米食品医薬品局）第III相ダブルブラインド臨床試験の成功した結果を発表している。この新たな試験はCM-ATがすべての自閉症児に効果をもたらす可能性があるのかどうかを判定する助けになる。

Curemarkの創立者でCEOのジョーン・ファロン博士は「われわれの目標は最初からわが社独自の自閉症薬をできるだけ多くのこの病気の子どもに届けることだった。この試験は自閉症児がCM-ATから恩恵を受けられる理由についての理解を劇的に深める可能性がある」と述べている。

Curemarkは現在、FDAのファストトラック（優先承認審査）指定を受けたCM-ATのローリング（段階的提出）新薬申請を提出している。ファストトラック指定は開発を容易にするのを助けるもので、満たされていない医療の必要を満たす可能性を示している深刻な病気や生命を脅かす病気を治療するための新薬の審査が速まる。

同社は米国各地の優秀な20の自閉症センターでこの試験を開始する。Curemarkのマシュー・ヒール最高科学責任者（CSO）は「この臨床試験を実施するためにいくつかのすぐれた臨床施設と臨床医を選んだ」と語っている。

臨床施設の現在のリストは www.clinicaltrials.govへ。

▽Curemark LLCについて

Curemarkは医薬品研究開発会社で、重要な胃腸／すい臓の分泌不全に対応することによって、神経科などの病気、特に自律神経疾患を伴うものの治療に集中している。同社はこれまでに、自閉症向けのCM-ATの第III相ダブルブラインド無作為偽薬対比マルチセンター臨床試験が主要、副次両エンドポイントを達成したと発表している。同社の革新的な科学についての詳しい情報はwww.curemark.comへ。

ソース：Curemark LLC

▽問い合わせ先

Michael Gursha

+1-914-925-3450

info@curemark.com

Curemark, LLC, Launches New Phase III Trial in Expanded Population of Children with Autism

PR60447

RYE, N.Y., May 11, 2015 /PRN=KYODO JBN/ --

   Curemark LLC, a privately held drug research and development company,

announced the start of a new Phase III double blind, randomized,

placebo-controlled clinical trial to examine the effect of its novel

formulation, CM-AT, on all children ages 3-8 with Autism. Previously, Curemark

announced the successful results of its FDA Phase III double blinded clinical

trial for CM-AT in children ages 3-8 with Autism who had low levels of the

digestive enzyme chymotrypsin. This new trial will help determine whether all

children with Autism could potentially benefit from CM-AT.

   Dr. Joan Fallon, Curemark Founder and CEO stated, "From the beginning, our

goal has been to bring our proprietary Autism drug to as many children with the

condition as possible.  This trial has the potential to dramatically deepen our

understanding around which children with Autism can benefit from CM-AT."

   Curemark is currently submitting its rolling New Drug Application for CM-AT

under the FDA's Fast Track designation.  A Fast Track designation is designed

to help facilitate the development and expedites the review of new drugs that

are intended to treat serious or life-threatening conditions that demonstrate

the potential to meet unmet medical needs.

   The company is initiating this trial at 20 centers of excellence for Autism

throughout the United States. "We have chosen some of the pre-eminent clinical

sites and clinicians to conduct this clinical trial," states Dr. Matthew Heil,

Curemark's Chief Scientific Officer.

   For a current list of clinical sites please go to: www.clinicaltrials.gov

   About Curemark LLC

   Curemark is a drug research and development company focused on the treatment

of neurological and other diseases, especially those with dysautonomic

components, by addressing certain key gastrointestinal/pancreatic secretory

deficiencies. The company previously announced that its Phase III double blind

randomized placebo controlled multicenter clinical trial of CM-AT for Autism

met its primary and secondary endpoints. To learn more about our innovative

science, visit: www.curemark.com

   Safe-Harbor Statements

   This news release contains forward-looking statements that involve risks and

uncertainties that could cause our actual results and experiences to differ

materially from anticipated results and expectations expressed in such

forward-looking statement. These forward-looking statements include, without

limitation, statements regarding the mechanism of action of the Curemark

products CM-AT, CM-4612 and CM-182 their potential advantages, their potential

for use in treating diseases or disorders, as well as the timing, progress and

anticipated results of the clinical development and regulatory processes

concerning the Curemark products CM-AT, CM-4612 and CM-182. These statements

are based on our current beliefs and expectations as to such future outcomes,

and are subject to known and unknown risks and uncertainties that may cause

actual future experience and results to differ materially from the statements

made. Factors that might cause such a material difference include, among

others, risks that the results of clinical trials will not support our claims

or beliefs concerning the effectiveness of the Curemark products CM-AT, CM-4612

and CM-182, our ability to finance our development of CM-AT, CM-4612 and CM-182

regulatory risks, and our reliance on third party researchers and other

collaborators. We assume no obligation to update these statements, except as

required by law.

    SOURCE: Curemark LLC

   CONTACT: Michael Gursha

            +1-914-925-3450

            info@curemark.com