Source: The Life Sciences Report 05/03/2017
Mesoblast Ltd., an Australia-based regenerative medicine company currently in a Phase 3 clinical trial in chronic heart failure, has received successful interim data, which prompted the Maxim Group to comment favorably on the study’s design and progress.
On April 10, Mesoblast Ltd. (MESO:NASDAQ; MSB:ASX) issued a press release announcing its “allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM in patients with moderate to advanced chronic heart failure (CHF) was successful in the pre-specified interim futility analysis of the efficacy endpoint in the trial’s first 270 patients.” The company plans to enroll about 600 patients.
The press release states that, “after notifying the Company of the interim analysis results, the trial’s Independent Data Monitoring Committee (IDMC) additionally stated that they had no safety concerns relating to MPC-150-IM and formally recommended that the trial should continue as planned.”
The primary endpoint of the interim analysis was “a comparison of recurrent heart failure related major adverse cardiovascular events (HF-MACE) between patients treated with MPC-150 and a control group,” according to an April 10 Maxim research report.
The Maxim analysts observed that Mesoblast’s trial design, which includes statistical analysis using the “Joint Frailty Model,” is a significant factor in determining the efficacy of the company’s stem cell treatment for heart failure.
“Smart statistical design represents one of multiple factors. It is more than a nuance, indicating an evolution of our understanding of clinical science, stem cells’ mechanism of action, and an improved understanding of heart failure itself,” the report states. “We believe that the therapy, delivery, time of delivery, dose, patient entry criteria, endpoints, and timing of this study all represent an evolution in our understanding.”
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Maxim also believes that “the probabilities of success for Mesoblast’s [heart failure] trial are substantially greater than is represented by the company’s current valuation.”
Maxim has a 12-month target price of $14 on Mesoblast; its shares are currently trading at around $11.75.
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Disclosure:
1) Tracy Salcedo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own shares of the following companies mentioned in this article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned are sponsors of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article, until one week after the publication of the interview or article.
The press release states that, after notifying the Company of the interim analysis results, the trial's Independent Data Monitoring Committee (IDMC) additionally stated that they had no safety concerns relating to MPC-150-IM and formally recommended that the trial should continue as planned.
The primary endpoint of the interim analysis was a comparison of recurrent heart failure related major adverse cardiovascular events (HF-MACE) between patients treated with MPC-150 and a control group, according to an April 10 Maxim research report.
The Maxim analysts observed that Mesoblast's trial design, which includes statistical analysis using the Joint Frailty Model, is a significant factor in determining the efficacy of the company's stem cell treatment for heart failure.
“Smart statistical design represents one of multiple factors. It is more than a nuance, indicating an evolution of our understanding of clinical science, stem cells' mechanism of action, and an improved understanding of heart failure itself, the report states. We believe that the therapy, delivery, time of delivery, dose, patient entry criteria, endpoints, and timing of this study all represent an evolution in our understanding.
Maxim also believes that the probabilities of success for Mesoblast's [heart failure] trial are substantially greater than is represented by the company's current valuation.
Maxim has a 12-month target price of $14 on Mesoblast; its shares are currently trading at around $11.75.
Want to read more Life Sciences Report articles like this? Sign up for our free e-newsletter, and you'll learn when new articles have been published. To see recent articles and interviews with industry analysts and commentators, visit our Streetwise Interviews page.
Disclosure: 1) Tracy Salcedo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own shares of the following companies mentioned in this article: None. She or members of her household are paid by the following companies mentioned in this article: None. 2) The following companies mentioned are sponsors of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. 3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. 4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports. 5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article, until one week after the publication of the interview or article."}
Additional Disclosures for this Content
Disclosures from Maxim Group, Mesoblast Ltd., Company Update, April 10, 2017
I, Jason Kolbert, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.
I, Jason McCarthy, Ph.D., attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.
I, Gabrielle Zhou, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report.
The research analyst(s) primarily responsible for the preparation of this research report have received compensation based upon various factors, including the firm’s total revenues, a portion of which is generated by investment banking activities.
Maxim Group makes a market in Mesoblast Ltd.
Maxim Group managed/co-managed/acted as placement agent for an offering of the securities for Mesoblast Ltd in the past 12 months.
Maxim Group received compensation for investment banking services from Mesoblast Ltd in the past 12 months.
Maxim Group expects to receive or intends to seek compensation for investment banking services from Mesoblast Ltd in the next 3 months.