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Wired News – Bellicum Pharma Shares Update On Clinical Hold of BPX-501 Studies in the US

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LONDON, UK / ACCESSWIRE / February 27, 2018 / Active-Investors.com has just released a free research report on Bellicum Pharma, Inc. (NASDAQ: BLCM). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=BLCM as the Company's latest news hit the wire. On February 23, 2018, the Company, which is a clinical stage biopharmaceutical organization that works towards discovering and developing cellular immunotherapies for cancers and orphan inherited blood disorders, shared an update on the clinical hold of US studies for its CAR-T candidate BPX-501. Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Bellicum Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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Bellicum shared that it has received a notification from the US Food and Drug Administration (FDA) which outlines the criteria required for lifting the clinical hold imposed on US studies of BPX-501.

About BPX-501

Bellicum's lead product candidate, BPX-501, has been specifically designed to improve outcomes for patients undergoing haplo-identical (i.e. partial match) hematopoietic stem cell transplants (HSCT). BPX-501 is an adjunct T cell therapy administered after HSCT. It comprises genetically modified donor T cells, based on Bellicum's CaspaCIDe® safety switch.

The use of BPX-501 provides the patient with the benefit of having T cells to fight infection, support engraftment, and prevent disease relapse. In case graft versus host disease (GvHD) occurs, the CaspaCIDe® safety switch can be activated to kill the toxic T cells. Thus, BPX-501 can improve outcomes and extend patient eligibility for a haplo-transplant. It also allows physicians to perform stem cell transplants more safely.

Clinical Hold on BPX-501 Studies Due to Encephalopathy Cases

Bellicum received a notice from the FDA to put a clinical hold on the US studies of BPX-501 on January 30, 2018. The agency suspended all studies after three cases of encephalopathy related to BPX-501 were reported.

However, it should be noted that the clinical hold does not affect the Company's BP-004 registration trial in Europe.

Bellicum's Plan of Action

  • Since the clinical hold was imposed last month, the Company had been waiting for a formal communication from the FDA to determine the requirements for resuming studies. Now that the FDA has outlined the criteria, Bellicum will work closely with the agency to address their requirements.
  • Bellicum intends to implement revisions to the US study protocols, such as the addition of more comprehensive monitoring and management of neurotoxicity.
  • Moreover, the Company plans to revise the Investigator Brochure and Informed Consent Documents to notify healthcare providers, patients, and caregivers of the changes.
  • The Company intends to provide a full response to the FDA with respect to these issues within a few weeks.

Improved Investor Sentiment

Bellicum's investors are waiting for the clinical hold to be lifted. The FDA's guidelines allow the Company to prepare a plan of action for obtaining the regulatory approval for BP-004.

Thus, the announcement about the FDA's notification went well with the investors. On the day of the announcement, shares were up 33% since bottoming at $5.02 on January 31, 2018, due to the news of clinical hold.

Stock Performance Snapshot

February 26, 2018 - At Monday's closing bell, Bellicum Pharma's stock rose 3.56%, ending the trading session at $7.28.

Volume traded for the day: 672.02 thousand shares.

After yesterday's close, Bellicum Pharma's market cap was at $229.68 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 1.0% at the end of the session.

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