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CellProthera and BioCardia Collaborate on Successful Phase II Trial of ProtheraCytes™ for the Treatment of Acute Myocardial Infarction

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CellProthera and BioCardia announced the successful completion of a collaborative Phase II trial of ProtheraCytes for treating acute myocardial infarction (AMI). The EXCELLENT Trial results showed that the transendocardial injection of ProtheraCytes, which are autologous, expanded CD34+ stem cells, in combination with standard care, helped prevent heart failure progression in high-risk heart attack patients.

The treatment demonstrated improvements in multiple efficacy endpoints, including better segment viability, consistent positive trends in LV volumes, and faster decreases in NTproBNP, a key heart failure biomarker. The therapy was well tolerated with no unexpected serious adverse events. Both companies plan to continue their collaboration into Phase III trials.

Positive
  • Successful completion of Phase II trial for ProtheraCytes.
  • Significant improvement in segment viability from baseline to six months.
  • Consistent positive trend in LV volumes at six months.
  • Faster decrease in NTproBNP biomarker.
  • No unexpected serious adverse events reported.
Negative
  • None.

The clinical success of the Phase II trial of ProtheraCytes™ in treating acute myocardial infarction (AMI) is noteworthy. This trial's positive results suggest the therapy's potential to improve patient outcomes significantly by preventing heart failure progression post-AMI. Notably, the use of autologous, expanded CD34+ stem cells showed no unexpected serious adverse events and resulted in considerable improvements in key efficacy endpoints, including cardiac tissue viability and reduced heart failure biomarkers.

Understanding the significance: The use of autologous stem cells means the therapy uses the patient's own cells, reducing the risk of immune rejection and adverse reactions. Improvements in left ventricular volumes and biomarkers like NTproBNP are vital indicators of better heart function and reduced heart failure risk. While these results are promising, they are preliminary and further validation in Phase III trials is needed.

Implications for stakeholders: For patients, this represents a potential new therapy that could significantly reduce the burden of heart failure following a heart attack. For investors, the success of this trial could drive value for both CellProthera and BioCardia as they advance to Phase III, positioning them as key players in the field of regenerative medicine.

BioCardia's stock (BCDA) could see positive momentum following this news. The successful completion of a Phase II trial often acts as a catalyst for stock price appreciation, especially in biotech. The announcement of a planned Phase III trial adds to the prospects, as it indicates a clear path toward potential commercialization. However, investors should remain cautious and consider the significant costs and risks associated with late-stage clinical trials.

Financial implications: The success in Phase II enhances BioCardia’s market position and could potentially attract partnerships or funding opportunities. The collaboration with CellProthera further strengthens their portfolio in cardiovascular therapies, which is a high-need market. On the flip side, the financial burden of Phase III trials could impact the company's financial health if not managed properly.

What to watch: Investors should pay close attention to upcoming announcements regarding the design, scope and timelines of the Phase III trial. Additionally, any partnership or funding news will be critical to understanding BioCardia’s financial runway for the upcoming trial phase.

The cardiovascular disease market is highly competitive and has a substantial unmet need for effective therapies. CellProthera and BioCardia’s collaborative approach using autologous CD34+ stem cells for AMI treatment is innovative and could address a significant gap in the current treatment landscape.

Market dynamics: The success of ProtheraCytes could position CellProthera and BioCardia favorably within the regenerative medicine sector, particularly in cell-based therapies for cardiac conditions. This area is seeing growing interest from both the medical community and investors, driven by the potential to address chronic conditions with novel therapies.

Potential market impact: If ProtheraCytes continues to show efficacy and safety through Phase III, it could capture a significant share of the cardiovascular therapy market, estimated to be worth billions globally. This would not only benefit patients but could also lead to significant revenue streams for both companies.

Considerations: The competitive landscape should not be underestimated, as other companies are also pursuing similar regenerative therapies. The ability to move quickly through trials, secure regulatory approvals and scale production will be critical factors for success.

MULHOUSE, France, and SUNNYVALE, Calif., July 08, 2024 (GLOBE NEWSWIRE) -- CellProthera, a private company specializing in cell-based therapies for repairing ischemic tissues, and BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announce success from a collaborative Phase II trial of ProtheraCytes for the treatment of acute myocardial infarction (AMI) led by CellProthera, as well as plans to continue the relationship into Phase III.

CellProthera’s clinical results from the Phase I/IIb EXCELLENT Trial, which studied the feasibility of transendocardial injection of ProtheraCytes for acute myocardial infarction when delivered in combination with the standard of care, suggested an effective solution for preventing heart failure progression in the patients at high risk following a heart attack.

The ProtheraCytes, which are autologous, expanded CD34+ stem cells, were well tolerated with no unexpected serious adverse events reported. Transendocardial administration of ProtheraCytes, performed utilizing the percutaneous catheter delivery system from BioCardia, was associated with improvements in multiple efficacy endpoints including a significant improvement of the viability of segments from baseline to six months, a consistent positive trend of improvement of LV volumes at six months, and a faster decrease in an important biomarker of heart failure, NTproBNP.

“The promising results of the study confirm the potential of our therapy to provide an effective one-off solution to prevent heart failure progression in AMI patients,” said Matthieu de Kalbermatten, CEO, CellProthera. “We are actively planning for what comes next and we have valued the responsiveness of the BioCardia team throughout the EXCELLENT trial in supporting training, attending clinical cases, and providing delivery systems. We have great learnings today that will enhance our efforts in what comes next, together.”

“The EXCELLENT trial has meaningful results for patient benefit using an approach that we feel makes enormous sense for locally administered high effective dosage of autologous CD34+ cells for these patients,” said Peter Altman, PhD, President and CEO of BioCardia. “I am personally impressed by their approach. It has been an honor to support CellProthera and we look forward to collaborating in the study to follow. We are ready for what comes next with enhancements to our delivery capabilities.”

About CellProthera

CellProthera is a regenerative cell therapy developer specializing in cardiovascular diseases with a leading program in myocardial infarction. CellProthera has developed a unique GMP-compliant cell expansion process as well as a proprietary automation technology for in vitro production of large quantity of purified, CD34+ stem cells. Its lead therapy ProtheraCytes™, is an autologous cell therapy and has been developed for body regeneration and targeted to regenerate various damaged tissues, including cardiac tissue. ProtheraCytes is registered as an Advanced Therapy Medicinal Product by the European Medicines Agency (EMA). CellProthera’s proprietary technology platform comprises an automated expansion device called StemXpand® and its disposable kit StemPack®. CellProthera is headquartered in France.

www.cellprothera.com/en/home

About BioCardia

BioCardia, Inc., is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP™ autologous and CardiALLO allogeneic cell therapies are the Company’s biotherapeutic platforms in three clinical stage product candidates in development. BioCardia also partners with other biotherapeutic companies to provide its delivery systems and development support to their programs.

www.biocardia.com

BioCardia Forward Looking Statements:

This press release contains forward-looking statements that are subject to many risks and uncertainties.  Forward-looking statements include, among other things, success of the future collaboration. These forward-looking statements are made as of the date of this press release.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate.  Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. The Company expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.


FAQ

What is BioCardia (BCDA) and CellProthera’s latest trial about?

The latest trial is a Phase II study of ProtheraCytes for treating acute myocardial infarction, showing promising results in preventing heart failure progression.

What are ProtheraCytes used for in the Phase II trial?

ProtheraCytes are used to treat acute myocardial infarction by preventing heart failure progression when injected transendocardially in combination with standard care.

What were the results of the Phase II trial involving BioCardia (BCDA) and CellProthera?

The Phase II trial showed significant improvements in segment viability, LV volumes, and NTproBNP levels, with no unexpected serious adverse events.

What are the next steps after the successful Phase II trial for BioCardia (BCDA) and CellProthera?

BioCardia (BCDA) and CellProthera plan to continue their collaboration into Phase III trials following the successful Phase II results.

What is the significance of NTproBNP in the Phase II trial of ProtheraCytes?

NTproBNP is an important biomarker for heart failure. The Phase II trial showed a faster decrease in NTproBNP levels, indicating the effectiveness of ProtheraCytes in preventing heart failure progression.

How were ProtheraCytes administered in the Phase II trial?

ProtheraCytes were administered transendocardially using BioCardia’s percutaneous catheter delivery system.

BioCardia, Inc.

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