REG - Hemogenyx Pharma Plc - IRB Approval for Phase I Clinical Trial

Hemogenyx PharmaceuticalsAnnouncement

22/11/2024 07:00

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RNS Number : 2344N  Hemogenyx Pharmaceuticals PLC  22 November 2024

22 November 2024

 

Hemogenyx Pharmaceuticals plc

("Hemogenyx Pharmaceuticals" or the "Company")

 

IRB Approval for Phase I Clinical Trial

 

Hemogenyx Pharmaceuticals Receives IRB Approval for Phase 1 Clinical Trial of
HEMO-CAR-T (HG-CT-1)

 

Hemogenyx Pharmaceuticals plc (LSE: HEMO), a biopharmaceutical company
developing innovative therapies and treatments for blood diseases, is pleased
to announce that the Institutional Review Board (IRB) of the Company's first
clinical site has granted approval to initiate a Phase I clinical trial of the
Company's lead asset, HEMO-CAR-T, which has now been given the formal
designation HG-CT-1, for the treatment of relapsed/refractory (R/R) acute
myeloid leukemia (AML) in adults.

 

The proposed Phase 1 clinical trial is designed as a dose escalation study to
assess the safety of HG-CT-1 in adult patients with R/R AML. Secondary
clinical objectives are crucial for evaluating the broader impact of HG-CT-1
and include:

·      Estimating the efficacy of HG-CT-1 based on standard clinical
response criteria for AML.

·      Estimating overall survival (OS) in evaluable subjects.

·      Estimating progression-free survival (PFS) in evaluable subjects.

·      Estimating duration of response (DoR) in evaluable subjects who
achieve a clinical response.

 

These objectives are pivotal for assessing the overall clinical impact of
HG-CT-1 on patients with R/R AML, a population with few remaining therapeutic
options. This IRB approval represents a significant milestone for Hemogenyx
Pharmaceuticals, enabling the Company to advance this promising therapy into
clinical testing at one of the world's most prestigious cancer research
institutions.

 

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals,
commented:

"We are excited to receive IRB approval to proceed with our Phase I clinical
trial of HEMO-CAR-T. This trial is a critical step in the development of our
CAR-T therapy for AML patients who have exhausted other treatment options.
With this study, we aim to establish the safety profile of HG-CT-1 and gather
preliminary efficacy data that could pave the way for future therapeutic
development."

 

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 forms 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 (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 (mailto: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 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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