LONDON, July 2, 2024
/PRNewswire/ -- Serac Healthcare Limited, a clinical
radiopharmaceutical company developing an innovative molecular
imaging agent, announced today that the US Food and Drug
Administration (FDA) has granted Fast Track Designation to
99mTc-maraciclatide as a
diagnostic SPECT-CT agent for the visualisation and diagnosis of
superficial peritoneal endometriosis in women of 16 years and
older.
Fast track is a process designed to facilitate the development
and expedite the review of drugs to treat (or in our case,
diagnose) serious conditions and fill an unmet medical need.
Criteria include improving the diagnosis of a serious condition
where early diagnosis results in an improved outcome.
Endometriosis is a common inflammatory disease that affects up
to one in 10 women of childbearing age, about 190 million women
worldwide. Endometriosis occurs when tissue similar to the lining
of the uterus is found outside the uterus, usually in the pelvis,
but sometimes also elsewhere in the body (e.g. the lungs). The
presence of this tissue can lead to significant pain and
infertility. It can be difficult to diagnose endometriosis because
the symptoms can vary considerably, and mimic those of other
conditions. This leads to an average delay of 7.5 years from first
symptom onset to diagnosis. Furthermore, superficial peritoneal
endometriosis (SPE) is the earliest and most common form of
endometriosis, comprising approximately 80% of all diagnoses.
However, due to the plaque-like nature and generally small size of
lesions, SPE is not well visualised with current non-invasive
imaging tools (ultrasound and MRI) and definitive diagnosis
requires laparoscopy.
Previously presented preliminary data from the "Detecting
Endometriosis expressed integrins using technetium-99m" (DETECT)
imaging study, demonstrated that 99mTc-maraciclatide correctly identified
superficial peritoneal endometriosis in those who went on to
have this early-stage endometriosis confirmed by
laparoscopy. The ongoing Phase II study will complete later
this year.
Benefits of Fast Track designation include:
- Eligibility for Accelerated Approval and Priority
Review, if relevant criteria are met
- More frequent meetings with FDA to discuss the drug's
development plan and ensure collection of appropriate data needed
to support drug approval
- More frequent written communication from FDA about such things
as the design of the proposed clinical trials
- Rolling Review, which means that a drug company can
submit completed sections of its New Drug Application (NDA) for
review by FDA, rather than waiting until every section of the NDA
is completed before the entire application can be reviewed.
All of which is intended to reduce the time to approval in the
US and enable patients to benefit sooner.
David Hail, Chief Executive
Officer of Serac Healthcare, said:
"Granting Fast Track designation to maraciclatide highlights
the FDA's recognition of the critical need for improved
diagnosis of endometriosis. The average delay for diagnosis of this
condition, which affects 190 million women worldwide, is seven and
a half years and is often only possible with laparoscopy. We are
committed to working closely with the FDA and clinicians to
complete the development of 99mTc-maraciclatide. A non-invasive test
which could be used for earlier diagnosis of endometriosis would
represent a major advance in women's healthcare."
About 99mTc-maraciclatide
99mTc-maraciclatide is
a radio-labelled tracer which binds with high affinity to the cell
adhesion protein αvβ3 integrin and images
angiogenesis (new blood vessel formation) which is known to be
critical to the establishment and growth of endometriotic lesions.
Clinical trials in a range of conditions, including breast cancer,
bone metastases and rheumatoid arthritis, in which angiogenesis
plays a key role, have shown the agent to perform as expected and
be well tolerated.
Maraciclatide is for investigational use only and is not
approved by the FDA or UK and European regulatory
authorities.
For more information, please contact:
Serac Healthcare Ltd
www.serachealthcare.com
David Hail, Chief
Executive
+44 (0)20 8948 0000
info@seraclifesciences.com
Francetta Carr,
Communications
+44 (0)7711 010820
francettacarr@seraclifesciences.com
Notes to Editors
About Serac Healthcare Ltd
Serac Healthcare is a clinical radiopharmaceutical company with
deep expertise in discovering, developing and commercialising
innovative molecular imaging technologies. Using these targeted
technologies to underpin personalised medicine in the fields of
endometriosis and inflammatory arthritis, Serac Healthcare is
focused on bringing to market effective tools to accelerate
diagnosis, and to deliver earlier and more effective treatment
decisions. Serac Healthcare Ltd is a wholly owned subsidiary of
Serac Life Sciences Limited.
About Fast Track designation
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
About the DETECT study
The study is jointly sponsored by the Oxford Endometriosis CaRe
Centre and the Nuffield Department of Women's and Reproductive
Health, Oxford University, and funded
by Serac Healthcare Ltd who are providing the experimental imaging
marker 99mTc-maraciclatide. Further details are
available on ClinicalTrials.gov here.
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SOURCE Serac Healthcare Limited