Fennec Announces Preliminary Results of SIOPEL 6 Study on PEDMARK™ (sodium thiosulfate) to be Presented at the 49TH Congres...
September 13 2017 - 11:17AM
Fennec Pharmaceuticals Inc. (TSX:FRX) (NASDAQ:FENC), 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, announced today
that the SIOP conference committee has advised of the acceptance of
a SIOPEL 6 abstract for presentation during the late breaker
session on Saturday, October 14, 2017 at SIOP 2017 in Washington,
DC.
In particular, Penelope Brock, M.D., PhD, International
Chair of SIOPEL, will present “SODIUM THIOSULFATE (STS) AS
OTOPROTECTANT TO REDUCE THE INCIDENCE OF CISPLATIN-INDUCED HEARING
LOSS: FINAL RESULTS OF THE SIOPEL 6 TRIAL FOR STANDARD RISK
HEPATOBLASTOMA (SR-HB).”
Details of Abstract 20 of the late breaker session posted on the
SIOP 2017 website today are as follows: Place: Marriott Wardman
Park Hotel, Marriott Salon 2Date and Time: October 14, 2017,
17:30-17:45
Background / Objectives:
Background: Bilateral high-frequency hearing loss is a serious
permanent side-effect of cisplatin therapy; particularly
debilitating when occurring in young children. STS has been shown
to reduce cisplatin induced hearing loss. SIOPEL 6 is a phase III
randomised trial to assess the efficacy of STS in reducing
ototoxicity in young children treated with cisplatin (Cis) for
SR-HB.
Design / Methods:
Methods: Newly diagnosed patients with SR-HB, defined as tumour
limited to PRETEXT I, II or III, no portal or hepatic vein
involvement, no intra-abdominal extrahepatic disease, AFP
>100ng/ml and no metastases, were randomised to Cis or Cis+STS
for 4 preoperative and 2 postoperative courses. Cisplatin 80mg/m2
was administered over 6 hours, STS 20g/m2 was administered
intravenously over 15 minutes exactly 6 hours after stopping
cisplatin. Tumour response was assessed after 2 and 4
preoperative cycles with serum AFP and liver imaging. In case of
progressive disease (PD), STS was to be stopped and doxorubicin
60mg/m2 combined to cisplatin. The primary endpoint is
centrally reviewed absolute hearing threshold, at the age of ≥3.5
years by pure tone audiometry.
Results:
Results: One hundred and nine randomised patients (52 Cis and 57
Cis+STS) are evaluable. The combination of Cis+STS was generally
well tolerated. With a follow up of 52months, 3yr EFS is Cis 80.4%
(95%CI 66.6%-88.9%) and Cis+STS 81.9% (68.8%-89.9%); 3yr OS is Cis
92.3% (80.8%-97.0%) and Cis+STS 98.2% (87.8%-99.7%). Treatment
failure defined as PD at 4 cycles was equivalent in both arms.
Among the first 94 evaluable patients, hearing loss occurred in
29/44=65.9% under Cis and in 19/50=38.0% under Cis+STS,
corresponding to a relative risk of 0.57(P=0.0069). Results will be
updated.
Conclusions:
Conclusion: This randomised phase III trial in SR-HB of
cisplatin versus cisplatin plus sodium thiosulfate shows that the
addition of sodium thiosulfate significantly reduces the incidence
of cisplatin-induced hearing loss without any evidence of tumour
protection.
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.
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. For more information, please visit
www.fennecpharma.com.
Forward looking statementsExcept 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 body 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
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