REG - Hemogenyx Pharma Plc - Submission of Complete Response to Clinical Hold

Hemogenyx PharmaceuticalsAnnouncement

16/01/2024 07:01

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20240116:nRSP7491Za&default-theme=true

RNS Number : 7491Z  Hemogenyx Pharmaceuticals PLC  16 January 2024

16 January 2024

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

 

Submission of Complete Response to Clinical Hold for HEMO-CAR-T IND

 

Hemogenyx Pharmaceuticals plc (LSE: HEMO) announces the submission of a
complete response to the previously announced Clinical Hold ("CH") of the
Investigational New Drug ("IND") application to the US Food and Drug
Administration ("FDA") for HEMO-CAR-T.  A complete response is necessary to
apply for the lifting of the CH which is needed to obtain consent from the FDA
to commence Phase I clinical trials of HEMO-CAR-T.

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented: "We are pleased to have filed a complete response to the FDA
addressing their concerns that resulted in a CH of the HEMO-CAR-T IND. We look
forward to becoming a clinical stage biopharmaceutical company once consent is
received from the FDA."

 

About AML and CAR-T Therapy

AML, the most common type of acute leukemia in adults, has poor survival rates
(a five-year survival rate of less than 30% in adults) and is currently
treated using chemotherapy, rather than the potentially more benign and
effective form of therapy being developed by Hemogenyx Pharmaceuticals. The
successful development of a new therapy for AML would have a major impact on
treatment and survival rates for the disease.

CAR-T therapy is a treatment in which a patient's own T-cells, a type of
immune cell, are modified to recognize and kill the patient's cancer cells.
The procedure involves: isolating T-cells from the patient; modifying the
isolated T-cells in a laboratory using a CAR gene construct (which allows the
cells to recognize the patient's cancer); amplifying (growing to large
numbers) the newly modified cells; and re-introducing the cells back into the
patient.

 

 

Enquiries:

 

 Hemogenyx Pharmaceuticals plc                                   https://hemogenyx.com (https://hemogenyx.com/)
 Dr Vladislav Sandler, Chief Executive Officer & Co-Founder      headquarters@hemogenyx.com (mailto:headquarters@hemogenyx.com)
 Peter Redmond, Director                                         Peter.redmond@hemogenyx.com

 SP Angel Corporate Finance LLP                                  Tel: +44 (0)20 3470 0470
 Matthew Johnson, Vadim Alexandre, Adam Cowl

 Peterhouse Capital Limited                                      Tel: +44 (0)20 7469 0930
 Lucy Williams, Duncan Vasey, Charles Goodfellow

 

 

About Hemogenyx Pharmaceuticals plc

Hemogenyx Pharmaceuticals is a publicly traded company (LSE: HEMO)
headquartered in London, with its US operating subsidiaries, Hemogenyx
Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its
state-of-the-art research facility.

The Company is a pre-clinical stage biopharmaceutical group developing new
medicines and treatments to treat blood and autoimmune disease and to bring
the curative power of bone marrow transplantation to a greater number of
patients suffering from otherwise incurable life-threatening diseases.
Hemogenyx Pharmaceuticals is developing several distinct and complementary
product candidates, as well as a platform technology that it uses as an engine
for novel product development.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  RSPGPUAWGUPCGQA