YASTEST
- Study met
primary endpoint (p=0.0033)
- Significant
reduction in cisplatin induced hearing loss without any evidence of
tumour protection in patients with Standard Risk Hepatoblastoma
(SR-HB)
- Company plans
to pursue regulatory approvals with FDA and EMA
RESEARCH TRIANGLE PARK, N.C., Oct.
16, 2017 (GLOBE NEWSWIRE) -- 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 greater than or equal
to 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 greater than or
equal to 1 hearing loss determined after the end of treatment
at the age of greater than or equal to 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 Raykov
Chief Executive Officer
Fennec Pharmaceuticals Inc.
T: (919) 636-5144
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Fennec Pharmaceuticals via Globenewswire
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