RESEARCH TRIANGLE PARK, N.C.,
June 1, 2015 /PRNewswire/
-- Fennec Pharmaceuticals, Inc. (TSX: FRX, OTCQB: FENCF),
announced the presentation of positive interim results from a
poster presented today entitled, "Anti-tumor efficacy in SIOPEL6: A
multi-centre open label randomised phase III trial of the efficacy
of sodium thiosulphate (STS) in reducing ototoxicity in patients
receiving cisplatin (Cis) monotherapy for standard risk
hepatoblastoma (SR-HB)." The data was presented at the American
Society of Clinical Oncology (ASCO) 2015 Annual Meeting in
Chicago. The poster is available
today on the website
http://fennecpharma.com/investors/presentations-events/.
"I am excited to be sharing very encouraging safety data on the
impact of STS in children with standard risk hepatoblastoma at ASCO," said Dr. Penelope
Brock, MD, PhD, FRCPCH, International Chair of SIOPEL. "STS
is very well tolerated. We are especially encouraged to see the
safety after six courses of Cisplatin with the addition of
STS."
"Our company's mission is to serve an unmet medical need for
patients treated with cisplatin chemotherapy by improving the
quality of life through the reduction of hearing loss," said
Rosty Raykov, Chief Executive
Officer. "We are very pleased with the interim safety results
presented at ASCO especially the conclusion, that, to date, STS as
a chemoprotectant appears to have no adverse effect on the efficacy
of cisplatin. We look forward to the data from the audiological
results from the trial."
SIOPEL6 is a multi-centre open
label randomized phase 3 study evaluating the efficacy of STS in
reducing ototoxicity in patients receiving Cis monotherapy for
SR-HB. The study is closed to recruitment and all protocol
pre-specified IDMC safety reviews are now complete.
From the beginning of 2007 to the end 2014, 45 sites from 11
countries enrolled 109 evaluable patients. Newly diagnosed
patients with SR-HB were treated with weekly cycles of Cis every
two weeks including 4 chemotherapy courses before primary
tumor resection and 2 courses after surgery. Patients were
randomized to Cis alone or Cis and STS. Cis of 80
mg/m2 was administered i.v. over 6 hrs. STS was
administered i.v. exactly 6 hrs after stop of Cis over 15 minutes
at 20 g/m2. Tumor response was assessed after 2 and 4
cycles pre-operative with serum AFP and liver imaging. In
case of progression after 2 cycles, STS was stopped and doxorubicin
60 mg/m2 continuous infusion over 48 hrs added. The primary
endpoint is centrally reviewed absolute hearing threshold, at the
age of ≥ 3.5 yrs, by pure tone audiometry. The trial has 80% power
to detect a reduction in hearing loss defined as Brock grade ≥ 1
from 60% of patients with Cis to 35% with Cis+STS.
The efficacy results indicate that it is safe to treat SR-HB
with six cycles of Cis monotherapy with the addition of the
chemoprotectant STS. Efficacy results at the end treatment
for the 109 evaluable patients (52 Cis, 57 Cis+STS) were complete
response/partial response/progressive disease for Cis: 85%/6%/4%
and for CIS+STS: 91%/7%/0%.
About 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., it is estimated that over 2,000 children are
diagnosed with local cancers that may receive platinum based
chemotherapy and globally over 5,000. 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 SIOPEL6. 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. SIOPEL6 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 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, 2014. Fennec
Pharmaceuticals, Inc. 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/fennec-announces-presentation-of-positive-interim-sodium-thiosulfate-phase-iii-safety-data-at-the-2015-asco-annual-meeting-300091596.html
SOURCE Fennec Pharmaceuticals, Inc.