Fennec Pharmaceuticals to Participate in Upcoming Investor Conferences
23 Mai 2022 - 1:29PM
Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty
pharmaceutical company focused on the development of
PEDMARKTM (a unique formulation of sodium thiosulfate) for the
prevention of platinum-induced ototoxicity in pediatric patients,
today announced that the Company will be participating in upcoming
conferences. The management team will also host one-on-one investor
meetings at the conferences.
Presentation Details:
Event: H.C. Wainwright Global Investment
Conference - HybridDate: May 24,
2022Time: Prerecorded presentation available
starting on Tuesday, May 24 at 7:00 am ET
Event: Craig-Hallum Institutional Investor
Conference - VirtualDate: June 1,
2022Time: One on One Investor Meetings
Event: JMP Securities Life Sciences
Conference in New York CityDate: June 15,
2022Time: 2:30 PM ET
For additional information, please visit the investor relations
section of the Company’s website
at:https://investors.fennecpharma.com/events-and-presentations/presentations.
About PEDMARK™
Cisplatin and other platinum compounds are
essential chemotherapeutic agents for many pediatric malignancies.
Unfortunately, platinum-based therapies cause ototoxicity, or
hearing loss, which is permanent, irreversible and particularly
harmful to the survivors of pediatric cancer.
In the U.S. and Europe, it is
estimated that, annually, over 10,000 children may receive
platinum-based chemotherapy. The incidence of ototoxicity
depends upon the dose and duration of chemotherapy, and many of
these children require lifelong hearing aids. There is currently no
established preventive agent for this hearing loss and only
expensive, technically difficult and sub-optimal cochlear (inner
ear) implants have been shown to provide some benefit. Infants and
young children that suffer ototoxicity at critical stages of
development lack speech language development and literacy, and
older children and adolescents lack social-emotional development
and educational achievement.
PEDMARK has been studied by cooperative groups
in two Phase 3 clinical studies of survival and reduction of
ototoxicity, The Clinical Oncology Group Protocol ACCL0431 and
SIOPEL 6. Both studies have been completed. The COG ACCL0431
protocol enrolled childhood cancers typically treated with
intensive cisplatin therapy for localized and disseminated disease,
including newly diagnosed hepatoblastoma, germ cell tumor,
osteosarcoma, neuroblastoma, and medulloblastoma. SIOPEL 6
enrolled only hepatoblastoma patients with localized tumors.
The Marketing Authorization Application (MAA)
for sodium thiosulfate (tradename PEDMARQSI) is currently under
evaluation by the European Medicines Agency (EMA).
PEDMARK has received Breakthrough Therapy and Fast Track
Designation by the FDA in March 2018.
About Fennec Pharmaceuticals
Fennec Pharmaceuticals Inc. is a specialty
pharmaceutical company focused on the development of
PEDMARK™ for the prevention of platinum-induced ototoxicity in
pediatric patients. Further, PEDMARK has received Orphan
Drug Designation in the U.S. for this potential use. Fennec has a
license agreement with Oregon Health and Science
University (OHSU) for exclusive worldwide license rights to
intellectual property directed to sodium thiosulfate and its use
for chemoprotection, including the prevention of ototoxicity
induced by platinum chemotherapy, in humans. For more
information, please visit www.fennecpharma.com
Forward Looking Statements
Except for historical information described in
this press release, all other statements are forward-looking. Words
such as “believe,” “anticipate,” “plan,” “expect,” “estimate,”
“intend,” “may,” “will,” or the negative of those terms, and
similar expressions, are intended to identify forward-looking
statements. These forward-looking statements include the Company’s
expectations regarding its interactions and communications with the
FDA, including the Company’s expectations and goals respecting the
NDA resubmission for PEDMARK™. Obtaining Fast Track Designation and
Breakthrough Therapy Designation by the FDA is no guarantee that
the FDA will approve the NDA resubmission of PEDMARK
Forward-looking statements are subject to certain risks and
uncertainties inherent in the Company’s business that could cause
actual results to vary, including the risk that unforeseen factors
may result in delays in or failure to obtain FDA approval of
PEDMARK, the risks and uncertainties relating to the Company’s
reliance on third party manufacturing, the risks that the Company’s
NDA resubmission does not adequately address the concerns
identified in the CRL previously provided by the FDA, the risk that
the NDA resubmission to the FDA will not be satisfactory, that
regulatory and guideline developments may change, scientific data
and/or manufacturing capabilities may not be sufficient to meet
regulatory standards or receipt of required regulatory clearances
or approvals, clinical results may not be replicated in actual
patient settings, unforeseen global instability, including
political instability, or instability from an outbreak of pandemic
or contagious disease, such as the novel coronavirus (COVID-19), or
surrounding the duration and severity of an outbreak, protection
offered by the Company’s patents and patent applications may be
challenged, invalidated or circumvented by its competitors, the
available market for the Company’s products will not be as large as
expected, the Company’s products will not be able to penetrate one
or more targeted markets, revenues will not be sufficient to fund
further development and clinical studies, the Company may not meet
its future capital requirements in different countries and
municipalities, and other risks detailed from time to time in the
Company’s filings with the Securities and Exchange
Commission including its Annual Report on Form 10-K for the
year ended December 31, 2021. Fennec disclaims any
obligation to update these forward-looking statements except as
required by law.
For a more detailed discussion of related risk
factors, please refer to our public filings available
at www.sec.gov and www.sedar.com.
For further information, please contact:
Investors:Robert AndradeChief Financial
OfficerFennec Pharmaceuticals Inc.(919) 246-5299
Media:Elixir Health Public RelationsLindsay
Rocco(862) 596-1304lrocco@elixirhealthpr.com
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