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Emmaus Life Sciences는 게실증 파일럿 시험에서게시글 내용
Emmaus Life Sciences는 게실증 파일럿 시험에서 추가적인 긍정적 인 예비 결과를보고합니다.
다운로드2020 년 8 월 5 일 오전 8시 EDT
-중간 분석은 게실 및 건강한 조직 수가 감소했음을 나타냅니다.
토클 런스 , 캘리포니아, 2020 년 8 월 5 일 (GLOBE NEWSWIRE)- 겸상 적혈구 질환 치료의 선두 주자 인 Emmaus Life Sciences, Inc. (OTCPK : EMMA) 는 오늘 가장 최근에 완료 한 2 명의 환자에 대한 예비 최고 데이터를 발표했습니다. 게실증의 파일럿 연구에서 예정된 12 개월 치료의 첫 6 개월. 이 연구는 Endari ® 에 사용 된 것과 동일한 제약 등급 L- 글루타민 (PGLG) 경구 분말을 사용하여 결장 게실의 수와 크기의 변화를 평가하고 안전성을 평가합니다.
다음 표는 데이터를 요약 한 것입니다.
PGLG에서 6 개월 치료 후 S 자 결장에서 게실의 수
환자 베이스 라인 6 개월 백분율 감소
52 세 여성 8 4 50 %
59 세 여성 7 0 100 %
S 자 결장이 게실염의 가장 빈번한 부위이기 때문에 Emmaus의 관찰은 S 자 결손에 초점을 맞 춥니 다. 이 환자들 각각에서 게실 수의 현저한 감소에 추가하여, 연구자는 기준선과 비교하여 분홍빛이 도는 건강한 점막의 출현을 주목했다. 환자들이보고 한 안전성 문제는 없었다.
Emmaus의 회장이자 CEO 인 MPi, MDH, MPH, Yutaka Niihara 박사는 다음과 같이 말했습니다. L- 글루타민은 장의 점막을지지하고 근육을 강화시키는 것으로 알려져 있습니다. 파일럿 연구가 여전히 진행되는 동안 Emmaus는 게실증 치료에서 PGLG의 효능과 안전성을 평가하기 위해 3 상 시험을 준비 할 것입니다.”
Emmaus는 미국, 유럽, 일본, 호주, 인도, 멕시코, 중국, 인도네시아, 한국 및 러시아에서 PGLG를 포함한 조성물과 관련된 특허 및 게실증 치료를위한 PGLG 투여 방법을 발표했습니다.
--Interim Analysis Indicates Decreased Number of Diverticula and Healthy Tissue--
TORRANCE, Calif., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Emmaus Life Sciences, Inc. (OTCPK: EMMA), a leader in sickle cell disease treatment, announced today preliminary top-line data for two patients who most recently completed the first six months of the scheduled twelve months of treatment in a pilot study of diverticulosis. The study is utilizing the same pharmaceutical-grade L-glutamine (PGLG) oral powder used in Endari® to evaluate the change in the number and size of colonic diverticula and assess safety.
The following table summarizes the data:
Number of diverticula in the sigmoid colon following six months treatment on PGLG
Patient | Baseline | Six Months | Percentage Reduction |
52 year-old female | 8 | 4 | 50% |
59 year-old female | 7 | 0 | 100% |
As the sigmoid colon is the most frequent site for diverticulitis, Emmaus’ observations are focused on sigmoid diverticula. In addition to the significant reduction in the number of diverticula, in each of these patients, the investigator noted the appearance of healthier mucosa with pinkish coloration compared to the baseline. There were no safety concerns reported by the patients.
Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus commented, “We are pleased to provide this remarkable topline data where we observed consistent improvement in the study patients. L-glutamine is known to support mucosa of the intestine and to strengthen musculature. While the pilot study is still ongoing, Emmaus will be preparing for a Phase 3 trial to assess the efficacy and safety of PGLG in the treatment of diverticulosis.”
Emmaus has issued patents in the U.S., Europe, Japan, Australia, India, Mexico, China, Indonesia, South Korea and Russia related to compositions, including PGLG, and methods of administration of PGLG for the treatment of diverticulosis.
About Diverticulosis
Diverticulosis, or the presence of colonic diverticula (i.e., pouches in the colon wall), is very common in industrialized nations. The prevalence of this condition increases with age. An estimated 40% of 60 year-olds and 70% of 80 year-olds in the U.S. have diverticulosis. Of these patients, 10% to 25% can be expected to develop diverticulitis, the advancement of peridiverticular inflammation and infection, resulting in abdominal pain, nausea, vomiting, constipation, diarrhea, fever and leukocytosis (i.e., abnormally high white blood cell count). Diverticulosis is an often asymptomatic gastrointestinal (GI) condition that can sometimes progress to diverticulitis, a debilitating GI disease that often requires hospitalization and on occasion surgical intervention.
About Emmaus Life Sciences
Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company engaged in the discovery, development, marketing and sale of innovative treatments and therapies, including those in the rare and orphan disease categories. For more information, please visit www.emmauslifesciences.com.
About Endari® (L-glutamine oral powder)
Indication - Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Important Safety Information
The most common adverse reactions (incidence >10 percent) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.
Adverse reactions leading to treatment discontinuation included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.
The safety and efficacy of Endari in pediatric patients with sickle cell disease younger than five years of age has not been established.
For more information, please see full Prescribing Information of Endari at: www.ENDARIrx.com/PI.
About Sickle Cell Disease
Sickle cell disease is an inherited blood disorder characterized by the production of an altered form of hemoglobin which polymerizes and becomes fibrous, causing red blood cells to become rigid and change form so that they appear sickle shaped instead of soft and rounded. Patients with sickle cell disease suffer from debilitating episodes of sickle cell crises, which occur when the rigid, adhesive and inflexible red blood cells occlude blood vessels. Sickle cell crises cause excruciating pain as a result of insufficient oxygen being delivered to tissue, referred to as tissue ischemia, and inflammation. These events may lead to organ damage, stroke, pulmonary complications, skin ulceration, infection and a variety of other adverse outcomes. Sickle cell disease is a significant unmet medical need, affecting approximately one hundred thousand patients in the U.S. and millions worldwide, the majority of which are of African descent. An estimated 1-in-365 African American children are born with sickle cell disease.
Forward-looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the preliminary observations in its diverticulosis study. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the risk that the preliminary analysis may change upon further evaluation or may not be able to be replicated in a larger patient sample and other risks and uncertainties inherent in early-stage clinical studies, risks and uncertainties related to the company’s working capital and ability to carry on its existing operations and obtain needed financing and other factors previously disclosed in the company’s reports filed with the Securities and Exchange Commission, and actual results may differ materially. Such forward-looking statements speak only as of the date they are made, and the company assumes no duty to update them except as required by law.
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