TIDMEVG
Evgen Pharma PLC
27 June 2023
Evgen Pharma plc
("Evgen" or "the Company" or "the Group")
Confirmation of SFX-01 radiosensitisation effect in-vivo in
Rhabdomyosarcoma
Alderley Park, UK - 27 June 2023 : Evgen Pharma plc (AIM: EVG),
a clinical stage drug development company developing
sulforaphane-based medicines , provides an update on the research
partnership with Sapienza University of Rome, which has confirmed
the radiosensitising effects of lead asset SFX-01 in-vivo in
Rhabdomyosarcoma (RMS), the most frequent soft tissue sarcoma in
childhood.
A radiosensitising agent is a drug that makes tumor cells more
sensitive to radiation therapy, enhancing its effectiveness. The
work was carried out by Prof. Francesco Marampon of the Department
of Radiotherapy and Dr Simona Camero of Prof. Francesca Megiorni's
research group at the Department of Experimental Medicine at the
Sapienza University of Rome.
Data* presented at the ESMO Sarcoma and Rare Cancers Congress in
March this year showed that SFX-01 was effective at reducing RMS
tumour cell growth in-vitro, both as a single agent and in
combination with radiotherapy where it was found to be
synergistic.
These positive effects have now also been confirmed in-vivo in a
mouse xenograft model of RMS. The group investigated the effects of
SFX-01 given orally on the growth of patient derived RMS tumour
cells, in-vivo.
SFX-01 was shown to be effective at reducing the growth of
tumour masses given as a single agent dosed once daily orally. It
was also given in combination with a radiotherapy regime where it
was shown to act synergistically, resulting in a more positive
outcome than would be expected by simply adding the two agents
together .
The data from both sets of studies will now be brought together
for submission to a peer reviewed publication.
Dr Helen Kuhlman, Evgen CBO, commented:
"The collaboration with Prof. Marampon's group continues to
generate very encouraging data on SFX-01 as a radiosensitising
agent - demonstrating the possibilities for SFX-01 wherever
radiotherapy is used as standard of care. Our clinical work has
shown that SFX-01 is safe and well tolerated, so its potential to
enhance the effects of radiotherapy without causing additional
therapeutic burden on patients is highly exciting."
Prof. Francesco Marampon, of Università Sapienza di Roma, Lead
Investigator, added:
"The systemic therapy of rhabdomyosarcomas has not changed in
recent decades and the frequent finding of locoregional recurrences
suggests the need for radiosensitising therapies that increase
local control. Unfortunately, with sarcomas, particularly with
rhabdomyosarcoma, exciting data are rarely obtained in vivo and,
precisely for this reason, I am very excited to observe this
result!"
Rhabdomyosarcoma (RMS) is a rare type of cancer that forms in
soft tissue and can develop in muscle, fat, blood vessels, or in
any of the other tissues that support, surround and protect the
organs of the body. RMS can occur at any age, but most often
affects children. The prognosis and treatment options depend on the
type of rhabdomyosarcoma, where it starts, tumour size and whether
the cancer has spread. Treatment is usually with a combination of
surgery, chemotherapy and radiation therapy. Currently, the
long-term outcomes in patients with metastatic rhabdomyosarcoma
remain poor.
SFX-01 is a patented composition of synthetic sulforaphane and
alpha-cyclodextrin. Evgen has already completed three trials of
SFX-01 in patients, demonstrating good safety data, including a
positive open label trial in metastatic breast cancer using the
prototype capsule formulation.
Evgen's core technology is Sulforadex(R), a method for
synthesising and stabilising sulforaphane and novel proprietary
analogues based on sulforaphane. Sulforaphanes have shown potential
benefits in neurodevelopmental disorders, oncology and inflammatory
conditions. SFX-01, Evgen's lead asset, is the only stabilised
sulforaphane suitable for clinical research and eventual approval
as a medicine.
* 105P SFX-01 in the treatment of rhabdomyosarcoma: Preclinical
results in cellular models - ESMO Open
-Ends-
Enquiries:
Evgen Pharma PLC
Dr Huw Jones, CEO
Richard Moulson, CFO
Dr Helen Kuhlman, CBO +44 1625 466591
FinnCap (Nominated Advisor and
Broker)
Geoff Nash / Teddy Whiley (Corporate
Finance)
Alice Lane/ Nigel Birks (ECM) +44 20 7220 0500
----------------------
Instinctif Partners +44 207 457 2020
Melanie Toyne-Sewell / Rozi Morris Evgen@Instinctif.com
/ Adam Loudon
----------------------
Notes to Editors
About Evgen Pharma plc
Evgen Pharma is a clinical stage drug development company
developing sulforaphane based medicines for the treatment of
multiple diseases. The Company's core technology is Sulforadex(R),
a method for synthesising and stabilising the highly biologically
active compound sulforaphane and novel proprietary analogues based
on sulforaphane.
The Company's lead asset, SFX-01, is a patented composition of
synthetic sulforaphane and alpha-cyclodextrin and has undergone
clinical trials for oestrogen-positive (ER+) metastatic breast
cancer and recently a Phase 1b study of the Company's new enteric
coated tablet formulation. The FDA has granted Orphan Drug status
to SFX-01 in malignant glioma. SFX-01 will be investigated
initially in this indication as an investigator sponsored study in
the Netherlands.
The Company also has a wide number of collaborations with
leading academic centres in the UK, Europe and the US as part of
the continuing strategy to build the scientific data for the
compound. With respect to areas outside of oncology and
inflammation, Evgen signed an out-licensing deal with JuvLife, the
dietary products and functional foods division of Juvenescence Ltd,
for the development of a naturally-sourced sulforaphane nutritional
health supplement, stabilised using Evgen's Sulforadex(R)
technology. More recently Evgen completed an out-licensing
transaction with Stalicla SA, a Swiss specialist company in
neurodevelopmental disorders, commencing with autism spectrum
disorder. The deal, if successful, will generate milestone payments
of $160.5m and a double-digit royalty on sales.
The Company has its headquarters and registered office at
Alderley Park, Cheshire. It is listed on AIM in London and trades
under the ticker symbol EVG.
For further information, please visit: www.evgen.com
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