Fennec Pharmaceuticals Inc. (NASDAQ:FENC) (TSX:FRX), a specialty
pharmaceutical company focused on the development of PEDMARKTM (a
unique formulation of sodium thiosulfate (STS)) for the prevention
of platinum-induced ototoxicity in pediatric patients, announced
today data from its Phase 3 SIOPEL 6 study presented during the
late breaker session on Saturday, October 14, 2017 at SIOP 2017 in
Washington, DC.
Top Line Efficacy Data
The SIOPEL 6 study met its primary endpoint.
The study demonstrated that the addition of STS significantly
reduces the incidence of cisplatin-induced hearing loss without any
evidence of tumour protection. Among the 99 evaluable patients,
hearing loss occurred in 30/45=67% treated with Cisplatin (Cis)
alone and in 20/54=37.0% treated with Cis+STS, corresponding to a
relative risk of 0.56(P=0.0033).
Fennec plans to pursue regulatory approval for
PEDMARKTM based on the data from the SIOPEL 6 study along with the
proof of principle data from COG ACCL0431. STS has received Orphan
Drug Designation in the US in this setting and plans to pursue
European Market Exclusivity for Pediatric Use upon approval.
“I am absolutely delighted that after 30 years
of research we have found a safe way to reduce ototoxicity in
children receiving platinum containing chemotherapy,”
said Penelope Brock, M.D., PhD, International Chair of
SIOPEL. “This means that children who are cured from cancer after
receiving platinum treatment can look forward to a normal healthy
life, fully integrated into society. I believe this marks a new
standard of care in pediatric oncology."
The Company also reported top-line data for
secondary endpoints Event Free Survival (EFS) and Overall Survival
(OS). The combination of Cis+STS was generally well tolerated. With
a follow up of 52 months, 3yr EFS is Cis 78.8% and Cis+STS 82.1%;
3yr OS is Cis 92.3% and Cis+STS 98.2%.
"We are very pleased with the results of this
study," stated Rosty Raykov, CEO of Fennec. "We would like to thank
all the patients and their families who participated in this trial,
physicians, the entire SIOPEL 6 team, and Dr. Neuwelt and his
research team at OHSU. We believe that if approved PEDMARK would be
an important therapy for patients and caregivers where currently
there are no treatment options.”
Safety and
Tolerability
In the study, the results presented showed that
treatment was well tolerated and acute toxicity similar and
expected between arms. The table below presents the toxicities of
the two arms:
Adverse event |
Grade |
CIS |
|
CIS+STS |
|
|
|
N |
% |
N |
% |
Febrile neutropenia |
3 |
7 |
13.5 |
5 |
8.8 |
4 |
- |
- |
- |
- |
Infection |
3 |
5 |
9.6 |
6 |
10.5 |
4 |
- |
- |
- |
- |
Hypomagnesemia |
3 |
1 |
1.9 |
1 |
1.8 |
4 |
- |
- |
- |
- |
Hypernatremia |
3 |
- |
- |
1 |
1.8 |
4 |
- |
- |
- |
- |
Vomiting |
3 |
1 |
1.9 |
3 |
5.3 |
4 |
- |
- |
- |
- |
Nausea |
3 |
3 |
5.8 |
2 |
3.5 |
4 |
- |
- |
- |
- |
SIOP 2017 Presentation
Fennec will provide access to the recording
of SIOP 2017 late breaker presentation on the Company's
website.
To access the archived recording, visit the
Fennec website at www.fennecpharma.com.
SIOPEL 6
SIOPEL 6 is a multi-centre open label randomized
phase 3 study evaluating the efficacy of STS in reducing
ototoxicity in patients receiving cisplatin monotherapy for
standard risk hepatoblastoma. From the beginning of 2007 to
the end 2014, 52 sites from 11 countries enrolled 113 evaluable
patients. The study is closed to recruitment and all protocol
pre-specified IDMC safety reviews are now complete. The
primary efficacy hearing endpoint analysis can be performed once
patients have reached 3.5 years of age and an audiometry test can
be carried out. The SIOPEL 6 study trial was designed with 80%
power and a 5% significance level to detect an absolute 25%
reduction in the rate of Brock grade ≥1 hearing loss with a
chi-square test, from a 60% hearing loss in Cis alone arm to a 35%
hearing loss in Cis+STS arm. The primary endpoint is the rate of
Brock grade ≥ 1 hearing loss determined after the end of treatment
at the age of ≥3.5 years by pure tone audiometry.
About PEDMARKTM (sodium thiosulfate/STS)
Cisplatin and other platinum compounds are
essential chemotherapeutic components for many pediatric
malignancies. Unfortunately, platinum-based therapies cause
ototoxicity in many patients, and are particularly harmful to the
survivors of pediatric cancer.
In the U.S. and Europe there is estimated that
over 7,000 children are diagnosed with local cancers that may
receive platinum-based chemotherapy. Localized cancers that receive
platinum agents may have overall survival rates of greater than 80%
further emphasizing the quality of life after treatment. The
incidence of hearing loss in these children 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 at
critical stages of development lack speech language development and
literacy, and older children and adolescents lack social-emotional
development and educational achievement.
STS 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 are closed to recruitment. The COG ACCL0431
protocol enrolled one of five 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. COG
ACCL0431 final results were published in the Lancet Oncology.
In May 2017, Fennec announced the launch of a
Named Patient Program in Europe. European based Healthcare
Professionals can obtain details about STS Named Patient Program by
emailing clinical@fennecpharma.com.
About Fennec
Pharmaceuticals
Fennec Pharmaceuticals Inc., is a specialty
pharmaceutical company focused on the development of Sodium
Thiosulfate (STS) for the prevention of platinum-induced
ototoxicity in pediatric patients. STS has received Orphan Drug
Designation in the US in this setting. Fennec has an exclusive
license agreement with OHSU for exclusive worldwide license rights
to intellectual property directed to STS 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.
Forward-looking statements are subject to certain risks and
uncertainties inherent in the Company’s business that could cause
actual results to vary, including such risks that regulatory and
guideline developments may change, scientific data 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, 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, 2016. Fennec Pharmaceuticals, Inc. disclaims any
obligation to update these forward-looking statements except as
required by law.
The scientific information discussed in this
news release related to PEDMARKTM is preliminary and investigative.
Such product candidates are not approved by the U.S. Food and Drug
Administration, Health Canada or other regulatory and no
conclusions can or should be drawn regarding the safety or
effectiveness of such product candidate.
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:
Rosty RaykovChief Executive OfficerFennec
Pharmaceuticals Inc.T: (919) 636-5144
Fennec Pharmaceuticals (TSX:FRX)
Historical Stock Chart
From Apr 2024 to May 2024
Fennec Pharmaceuticals (TSX:FRX)
Historical Stock Chart
From May 2023 to May 2024