---
title: "Hemogenyx Pharma Plc (LON:HEMO) Submission of Complete Response to Clinical Hold"
publisher: "Share Talk"
author: "sharetalk"
published: "2024-01-16T12:01:43+00:00"
modified: "2024-01-16T12:01:43+00:00"
date: 2024-01-16
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category: "Health"
categories: ["Health", "Healthcare", "Pharmaceutical"]
tags: ["biopharmaceutica", "COVID-19", "Dr Vladislav Sandler", "Global Pharma", "gold rush", "H.C. Wainwright", "HEMO", "Hemogenyx", "Hemogenyx Pharma", "Pharma", "Share Talk", "Vladislav Sandler"]
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---

# Hemogenyx Pharma Plc (LON:HEMO) Submission of Complete Response to Clinical Hold

**Published:** January 16, 2024
**Author:** sharetalk
**Categories:** Health, Healthcare, Pharmaceutical
**Tags:** biopharmaceutica, COVID-19, Dr Vladislav Sandler, Global Pharma, gold rush, H.C. Wainwright, HEMO, Hemogenyx, Hemogenyx Pharma, Pharma, Share Talk, Vladislav Sandler
**Featured image:** ![](https://i0.wp.com/www.share-talk.com/wp-content/uploads/2023/11/Hemogenyx-Pharma-27_11_23.jpg?fit=1200%2C800&quality=89&ssl=1)

---

**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 |

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