Hemogenyx Pharmaceuticals PLC Clinical Hold Lift Plan is accepted by FDA (3723M)
September 14 2023 - 1:00AM
UK Regulatory
TIDMHEMO
RNS Number : 3723M
Hemogenyx Pharmaceuticals PLC
14 September 2023
14 September 2023
Hemogenyx Pharmaceuticals plc
("Hemogenyx Pharmaceuticals" or the "Company")
Clinical Hold Lift Plan is accepted by FDA
Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical
group developing new therapies and treatments for blood diseases,
announces that the U.S. Food and Drug Administration ("FDA") has
accepted the Company's plan to address the FDA's concerns that
resulted in a Clinical Hold ("CH") of the HEMO-CAR-T
Investigational New Drug ("IND") application.
Further to the announcement on 10 July 2023, Hemogenyx
Pharmaceuticals carefully considered the comments provided by the
FDA in connection with the CH and responded in August 2023 with a
detailed plan, supported by laboratory tests, to address those
comments. The Company has now received confirmation from the FDA
that the Company's plan satisfactorily addresses the agency's
comments.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx
Pharmaceuticals, commented: "We are pleased that the FDA has agreed
to our plan and preliminary test results to address their concerns
regarding our HEMO-CAR-T IND application. We are now working hard
to complete the schedule of work set out in the plan and to
re-submit the IND as expeditiously as possible in order to move
forward with clinical trials of HEMO-CAR-T."
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.
Market Abuse Regulation (MAR) Disclosure
Certain information contained in this announcement would have
been inside information for the purposes of Article 7 of Regulation
No 596/2014 (as it forms part of UK domestic law by virtue of the
European Union (Withdrawal) Act 2018) until the release of this
announcement. The person responsible for arranging for the release
of this announcement on behalf of Hemogenyx Pharmaceuticals plc is
Dr Vladislav Sandler, Chief Executive Officer & Co-Founder.
Enquiries:
Hemogenyx Pharmaceuticals plc https://hemogenyx.com
Dr Vladislav Sandler, Chief Executive
Officer & Co-Founder headquarters@hemogenyx.com
Peter Redmond, Director peter.redmond@hemogenyx.com
Tel: +44 (0)20 3470
SP Angel Corporate Finance LLP 0470
Matthew Johnson, Vadim Alexandre,
Adam Cowl
Tel: +44 (0)20 7469
Peterhouse Capital Limited 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.
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