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Evgen Pharma receives go ahead for haemorrhage drug trial

Wed, 11th Jan 2017 09:23

(ShareCast News) - Evgen Pharma, a clinical stage drug development company focused on the treatment of cancer and neurological conditions, has received a positive interim safety review from the independent Data Safety Monitoring Board (DSMB) for its Phase II double-blind placebo-controlled SAS trial of SFX-01 in subarachnoid haemorrhage (SAH).The DSMB review was part of the SAS trial protocol and was triggered by the 20th patient being does for a minimum of seven days whilst in hospital care. The review resulted in a recommendation to proceed as planned, continuing the dosages after being discharged for up to 28 days.SFX-01, a synthetic and stabilised version of the naturally occurring plant compound sulforaphane, potentially represents a new class of drug in SAH, with a mechanism of action that specifically targets the Nrf-2 pathway and has the effect of reducing the oxidative stress and toxicity caused by free haemoglobin from the haemorrhage.Nimodipine is the current standard of care and has a different action. It has been generic for more than 20 years during which time there have been no significant clinical advances in the treatment of SAH.The SAS trial is a randomised, double blind, placebo controlled study in which half of the patients will receive SFX-01 and nimodipine and the other half will receive placebo ad nimodipine. A total of 90 patients will be enrolled. A total of 26 patients have been enrolled in the study to date.Chief executive of Pharma Dr Stephen Franklin said: "We are delighted that the DSMB has given a favourable review of our Phase II study of SFX-01 in subarachnoid haemorrhage, a rare but devastating condition with high unmet clinical need. This is the first safety review of SFX-01 in a patient cohort and as such represents an important milestone in the clinical development of SFX-01."The share price fell 1.63% to 24.10p at 1027 GMT on Wednesday.
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Evgen Pharma finds evidence of SFX-01 activity in colon cancer models

(Alliance News) - Evgen Pharma PLC on Tuesday said it found further evidence of SFX-01 activity in models of colon cancer.

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19 Feb 2024 11:45

Evgen Pharma shares up on studies into SFX-01 product progressing well

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9 Feb 2024 17:02

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16 Jan 2024 18:59

IN BRIEF: Evgen partner raises USD17.4 million to support pipeline

Evgen Pharma PLC - clinical stage drug development company developing sulforaphane-based medicines - Notes that its partner in autism spectrum disorder and other neurodevelopmental disorders Stalicla SA has announced that it has raised USD17.4 million, inclusive of a credit facility. This is to to support programmes on STP1, Stalicla's first asset in ASD, and a further asset in substance use disorders together with a biosampling and patient identification study in ASD. Evgen says it continues to work with Stalicla on delivery of a milestone payment for SFX-01 (Stalicla's STP2). Evgen says both parties are engaged in analysis and interpretation of Evgen's recent Phase 1b healthy volunteer PK/PD study and the implications for a future phase 2 trial in ASD. Evgen says it will provide updates on the status of the programme in "due course" and has not anticipated any milestone payments from Stalicla in its financial forecasting.

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22 Dec 2023 18:06

IN BRIEF: Evgen appoints Toni Hanninen as permanent CFO

Evgen Pharma PLC - clinical stage drug development company developing sulforaphane-based medicines - Appoints Toni Hanninen as permanent chief financial officer, adding that he will now join the board as a director. Hanninen was appointed as interim CFO in September, having previously worked at Faron Pharmaceuticals Ltd. His permanent appointment becomes effective from January 1. Evgen also confirms that non-executive director, Susan Clement-Davies, will be retiring from the board.

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Evgen upbeat on start of glioblastoma research project

(Sharecast News) - Clinical-stage drug developer Evgen Pharma announced on Thursday that it has partnered with Dr Marjolein Geurts, a neuro-oncologist at Erasmus University Medical Centre, to start a ground-breaking research initiative in glioblastoma.

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19 Oct 2023 19:39

IN BRIEF: Evgen showcases importance of new enteric-coated formulation

Evgen Pharma PLC - Cheshire, England-based clinical stage drug developer - Highlights article published in respected industry publication the Medicine Maker, by its Chief Business Officer, Helen Kuhlman. The article, entitled the Sulforaphane Promise, focuses on the recent study of Evgen's new enteric-coated tablet formulation, and why enteric coatings are of particular importance for a stabilised complex such as SFX-01 that releases highly biologically active sulforaphane. The SFX-01 complex is vulnerable to breakdown in acid conditions and the enteric coat prevents acid attack in the stomach, releasing the drug in the ideal region - the small bowel. It also discusses the pharmacodynamic and pharmacokinetic data from the recent study, demonstrating the improvements of the tablet formulation over previous formulations of SFX-01.

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5 Sep 2023 14:22

Evgen Pharma hires interim CFO from Faron, chair to retire this month

(Alliance News) - Evgen Pharma on Tuesday said Non-Executive Chair Barry Clare will retire at its next board meeting, and announced the hiring of interim Chief Financial Officer Toni Hanninen.

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15 Aug 2023 10:01

Evgen Pharma says trial shows new SFX-01 drug formulation is safe

(Alliance News) - Evgen Pharma PLC on Tuesday said final data from a trial of its SFX-01 therapy has shown a new formulation of the drug is safe.

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2 Aug 2023 10:28

IN BRIEF: Evgen Pharma shares drop on ending of license agreement

Evgen Pharma PLC - Cheshire, England-based clinical stage drug development company focused on developing sulforaphane-based medicines - Terminates the patent and know-how license agreement for its Sulforadex sulforaphane stabilisation technology with partner JuvLife Ltd. The exclusive rights will be returned in the final quarter of 2023. The already received upfront payment is non-refundable.

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