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Karyopharm Therapeutics
Inc.
, a clinical-stage pharmaceutical company, announced today
the presentation of clinical data from an ongoing Phase 1 clinical study for
its lead product candidate, Selinexor (KPT-330), a first-in-class, oral
Selective Inhibitor of Nuclear Export / SINE(TM) compound, in patients with
advanced solid tumors. Data presented in patients with chemotherapy
refractory, castrate-resistant prostate cancer (CRPC) treated with
single-agent Selinexor showed a 60% disease control rate with maximum
prostate-specific antigen (PSA) reduction ranging from 27% to 60% and
duration of treatment up to 502 days. Selinexor also demonstrated early
signs of clinical activity in other solid tumor indications including head
and neck squamous cell carcinoma and ovarian cancer. Selinexor was shown to
have manageable and predictable side effects, primarily nausea, fatigue and
anorexia, which improve over time on treatment. These data were presented at
the 2014 Congress of the European Society for Medical Oncology (ESMO),
occurring September 26-30, 2014 in Madrid, Spain. The company will host a
conference call to discuss the ESMO data on Monday, September 29, 2014 at
4:30pm ET.
"We continue to be impressed with the performance of Selinexor in advanced
solid tumors," stated Dr. Sharon Shacham, PhD, President and CSO of
Karyopharm. "In particular, the clinical activity and safety profile
demonstrated in patients with chemotherapy refractory, castrate-resistant
prostate cancer were very encouraging as these heavily pretreated patients
have no other standard treatment options available. The safety and response
data reported at ESMO further support our decision to proceed with Phase 2
studies in this difficult-to-treat patient population."
In an oral presentation entitled "Selinexor (KPT-330), an Oral, Selective
Inhibitor of Nuclear Export (SINE) Shows Anti-Prostate Cancer (PrCa)
Activity Preclinically & Disease Control in Patients (pts) with Chemotherapy
Refractory, Castrate-Resistant Prostate Cancer (CRPC)", data evaluated as of
September 10, 2014, demonstrated that of 15 enrolled patients, nine (60%)
achieved stable disease and two (13%) had progressive disease with time to
progression ranging from 31 to 502 days on study. Four patients were not
evaluable for response.
"These data reveal Selinexor to be generally well-tolerated with manageable
side effects and promising PSA decreases in patients with chemotherapy
refractory, castrate-resistant prostate cancer," said Christopher J.
Logothetis, M.D., Department Chair, Department of Genitourinary Medical
Oncology, Division of Cancer Medicine, The University of Texas MD Anderson
Cancer Center. "Though early, these data support further studies of
Selinexor in patients with treatment-resistant prostate cancer."
Karyopharm has previously announced the initiation of a Phase 2
single-agent, open-label study of Selinexor in patients with metastatic
CRPC. The study, referred to as Selinexor in Hormone Refectory Indications
in Prostate Cancer, or SHIP, is expected to evaluate approximately 50
patients with adenocarcinoma of the prostate with evidence for skeletal
metastases on bone scan and/or CT scan. Approximately 50 qualifying patients
with metastatic CRPC following at least one of the recently approved agents
(enzalutamide, abiraterone or radium 223) will receive 50 mg/m(2) of
Selinexor orally twice per week over each 28-day cycle. The study is being
conducted at the MD Anderson Cancer Center lead by Drs. Christopher
Logothetis and John Araujo. The primary goal of the study is to determine
the disease control rate assessed according to RECIST criteria and the
prevention of new bone lesions. The secondary goal of the study is to
evaluate the PSA response relative to baseline. Additional studies in
prostate cancer patients are planned.
In addition to data in patients with prostate cancer, Phase 1 study data was
also presented that demonstrates the potential of Selinexor as a treatment
for other heavily pretreated solid tumor indications, including head and
neck squamous cell carcinoma and ovarian cancer. In a poster presentation
entitled "Clinical Activity of the Oral Selective Inhibitor of Nuclear
Export (SINE) Selinexor (KPT-330) in Patients with Head & Neck Squamous Cell
Carcinoma (HN-SCC)", single-agent Selinexor was shown to stabilize disease
progression in 11 (69%) of 16 heavily pre-treated patients with different
types of head and neck squamous cell carcinomas. Several patients with
thymic epithelial carcinomas showed durable disease shrinkage
Based on the favorable safety profile to date and encouraging efficacy data,
Karyopharm has initiated a Phase 2 single-agent study of Selinexor in
patients with squamous cell carcinomas. The study, referred to as Selinexor
Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas, or
STARRS, is expected to evaluate approximately 66 patients with head and
neck, lung and esophageal squamous cell carcinomas who have relapsed or have
metastasis following chemotherapy. Eligible patients have received one or
two prior therapies and have demonstrated progressive disease upon
enrollment. Patients will receive single-agent oral Selinexor dosed twice
weekly at 55 mg/m(2) . The study will be conducted at approximately 28 sites
in the United States and Canada. Disease control rate, defined as stable
disease or better, is the primary endpoint.
In a second poster presentation entitled "Preclinical and Early Clinical
Activity of the Oral Selective Inhibitor of Nuclear Export (SINE) Exportin 1
(XPO1) Antagonist Selinexor (KPT-330) in Patients (pts) with Platinum
Resistant/Refractory Ovarian Cancer (OvCa)", Selinexor administered to seven
heavily-pretreated patients with ovarian cancer was shown to induce durable
disease stabilization or tumor size reduction, including one partial
response, in three (60%) of five evaluable patients. Two patients (40%)
experienced progressive disease and two patients withdrew consent or were
not evaluable. Side effects were generally low grade and typically
gastrointestinal in nature, or fatigue. These common side effects decreased
over time, in part due to prophylactic use of standard supportive care.
Major organ dysfunction or clinically significant cumulative toxicities have
not been observed.
Karyopharm has previously announced the initiation of a Phase 2 single-agent
study of Selinexor in patients with advanced gynecological malignancies. The
study, referred to as Selinexor in Gynecology Neoplasms, or SIGN, is
expected to evaluate approximately 63 patients with ovarian carcinoma,
endometrial carcinoma and cervical carcinoma. Eligible patients have
demonstrated progressive disease upon enrollment and have received at least
one line of chemotherapy following relapse or, in the case of endometrial or
cervical carcinomas, to treat advanced (stage IVb) disease. Patients receive
single-agent oral Selinexor dosed twice weekly at 50 mg/m(2) . The study is
being conducted at approximately four sites in Europe. The primary goal of
the study is to determine the disease control rate assessed according to
RECIST criteria.
About the Phase 1 Study Design
This study of approximately 200 patients is an open label, multi-center
study that was designed to determine the safety, tolerability and
recommended Phase 2 dose of Selinexor with advanced or metastatic solid
tumor cancers relapsed or refractory after multiple previous treatments and
objectively progressing on study entry with no standard treatment options
available. Other study endpoints include pharmacokinetics, pharmacodynamics,
anti-tumor response and confirmation of recommended Phase 2 dose of
Selinexor in this patient population. Patients were dosed orally between 3
mg/m(2) and 85 mg/m(2) three times weekly, twice weekly or once weekly and
response evaluation was done every 2 cycles in accordance with RECIST
criteria.
Webcast Information
Karyopharm will host a webcast and conference call today at 4:30 p.m. ET to
discuss the data presented at ESMO. The webcast will be available on the
Investors & Media section of the company's website,
investors.karyopharm.com/events.cfm. To access the conference call, please
dial (855) 437-4406 or (484) 756-4292 (international) at least five minutes
prior to the start time and refer to conference ID 11655910. An archived
webcast will be available on the Company's website approximately two hours
after the event.
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