AUS
NZ
UK
CA
USA
FRA
GER
ESP
ITA
NLD
PRT
SWE
GRC
IND
POL
BRA
ZAF
RUS
CHN
UAE
Mesoblast Limited (ASX:MSB) has entered the final stage of Phase 3 Trial of Revascor Cell therapy for advanced heart failure as the company has dosed its last patient in Phase 3 event-driven trial. The news sent the stock to edge up by 0.858% to last trade at $1.175 on 19 February 2019.
A global leader in the development of cellular medicines, Mesoblast, has utilised its proprietary technology platform to create an extensive portfolio of off-the-shelf product candidates. In Phase 3 Trial, the company has been working on the development of three major candidates that include chronic heart failure, acute graft versus host disease, and chronic low back pain due to degenerative disc disease.
The Phase 3 trial demonstrates the significant results the company had received in the Phase 2 trial with patients being benefitted from Revascor when they were at high risk of recurrent hospitalisation events and death. With these Phase 2 results, the company had backing in trial design and selection criteria for the registration of high-risk patients in its ongoing Phase 3 trial.
According to the report, the 566-patients trial will be completed once the primary endpoint events have accrued to a sufficient level which is expected to take the next 12 months. The company believes that the total number of randomised patients enrolled in the Phase 3 trial is good enough to represent the superiority of Revascor over Placebo in the key endpoint of the trial to show the reduction in heart failure-related hospital admissions and in the secondary endpoint of reduction in cardiac deaths.
More interestingly, the companyâs cardiovascular partner in China, Tasly Pharmaceutical Group, is looking forward to getting the Mesoblastâs Revascor cell therapy approved in China. As per the report, Tasly is planning to have a meeting with Chinaâs food and drug regulatory body National Medical Products Administration (NMPA) in the first quarter of 2019 to discuss the regulatory approval pathway for Revascor in China. Its core objective is to commence the Phase 3 trial of Revascor in China using similar clinical endpoints. Tasly and Mesoblast intend to strengthen their clinical trial results together to support their respective regulatory submissions in the United States, China and other geographical areas.
The company has recognised more than 8 million patients suffering from chronic heart failure in the United States alone and up to 20% progress to advanced heart failure that has been resistant to all existing medicines is categorised as New York Heart Association Class III or IV disease. Therefore, Mesoblast has been leveraging its proprietary technology in the development of product candidate for chronic heart failure.
Moreover, the company unveiled its commercial and development plans in the recently held Biotech Showcase 2019. Revascor forms the key highlight in the companyâs development plan under which the company eyes 2019 as a crucial year for the companyâs heart failure product candidate.
MSB stock price has declined by 14.65% over the past 12 months including the massive negative change of 10.73% in the past three months.
Disclaimer
This website is a service of Kalkine Media Pty. Ltd. A.C.N. 629 651 672. The website has been prepared for informational purposes only and is not intended to be used as a complete source of information on any particular company. Kalkine Media does not in any way endorse or recommend individuals, products or services that may be discussed on this site. Our publications are NOT a solicitation or recommendation to buy, sell or hold. We are neither licensed nor qualified to provide investment advice.
