In the study CAM2029 provided long-acting octreotide release with well
-maintained control of symptoms and disease biomarkers after switching from
Sandostatin® LAR®*
Lund — 12 July 2016 — Camurus announces the completion of a multi-center Phase 2
study of long-acting octreotide FluidCrystal® formulation (CAM2029), supporting
its potential in treating patients with acromegaly or neuroendocrine tumors
(NETs). CAM2029 is an investigational treatment developed as an alternative to
current long-acting somatostatin analogue formulations. The product is designed
to be ready-to-use and is administered subcutaneously as a small volume
injection. This makes it suitable for self-administration. In the present study,
treatment with CAM2029 resulted in therapeutic blood-levels of octreotide over
four weeks. The safety and local tolerability of CAM2029 was good and consistent
with the marketed reference product Sandostatin® LAR®.
“The results from this Phase 2 study of CAM2029 are encouraging, with long
-acting octreotide release and sustained disease control seen in patients with
acromegaly as well as neuroendocrine tumors,” said lead investigator Professor
Marianne Pavel, MD, Senior Physician and Leader of the Section for
Neuroendocrine Tumors in the Department of Hepatology and Gastroenterology at
the Charité-Universitätsmedizin, Berlin, Germany.
“The positive pharmacokinetic profile and promising disease control data seen in
this Phase 2 study when switching patients from Sandostatin®LAR®to CAM2029,
together with the option for self-administration by patients, underscores the
potential for CAM2029 to fill an unmet medical need,” said Fredrik Tiberg, PhD,
President & CEO of Camurus. “As a next step, we look forward to the initiation
of planned Phase 3 trials by our collaborator Novartis”.
About the Phase 2 Trial
The Phase 2 study was designed as an open-label multicentre, randomised study to
assess the PK, PD, efficacy, and safety of two dosing regimens of CAM2029.
Twelve adult patients with acromegaly or a functional, well-differentiated NET
with carcinoid symptoms, previously treated and stabilized with Sandostatin®
LAR®, were included in the trial. Additional information on the design of the
trial can be found at www.clinicaltrials.gov.
About CAM2029
The investigational long acting CAM2029 octreotide subcutaneous product for
treatment of acromegaly and NET is being developed as a ready-to-use injection
in a prefilled syringe equipped with a needle stick safety device that supports
CAM2029 administration by patients themselves. The CAM2029 product has been
studied in four Phase 1/2 clinical trials, which have evaluated the safety and
tolerability as well as pharmacokinetic and pharmacodynamic properties of the
product in a total of about 250 individuals. Preparations are currently ongoing
for Phase 3 trials of CAM2029 expected to start in 2017. CAM2029 is developed by
Novartis under an exclusive collaboration, option and license agreement with
Camurus.
About Sandostatin® (octreotide acetate)
Sandostatin® LAR is indicated for the treatment of patients with symptoms
associated with functional gastro-entero-pancreatic neuroendocrine tumors:
carcinoid tumors with features of the carcinoid syndrome, VIPomas,glucagonomas,
gastrinomas/Zollinger-Ellison syndrome, insulinomas, GRFomas.Treatment of
patients with advanced neuroendocrine tumors of the midgut or unknown primary
tumor location. Sandostatin LAR is also indicated for the treatment of patients
with acromegaly in whom surgery or radiotherapy is inappropriate of ineffective
or in the interim period until radiotherapy becomes fully effective.
Contraindications: Known hypersensitivity to octreotide or to any of the
excipients.
Warnings and Precautions: Patients should be carefully monitored for tumor
expansion. Treatment could potentially restore fertility in female patients of
child bearing potential. Use adequate contraception during treatment. Cases of
bradycardia have been reported. Dose adjustments of drugs such as beta-blockers,
calcium channel blockers, or agents to control fluid and electrolyte balance,
may be necessary. Gallbladder abnormalities may occur. Patients should be
monitored periodically. Rare instances of sudden escape from symptomatic control
in patients with GEP neuroendocrine tumors may occur in patients being treated
with Sandostatin Injection with rapid recurrence of severe symptoms.
Hypoglycemia or hyperglycemia may occur. Blood glucose levels should be
monitored when treatment is initiated or when the dose is altered especially in
patients with Type 1 diabetes. Antidiabetic treatment should be adjusted
accordingly. Caution in patients with insulinomas or diabetes mellitus. These
patients should be monitored closely.
Octreotide may alter absorption of dietary fats in some patients. Monitoring of
vitamin B12 levels is recommended in patients with a history of vitamin B12
deprivation. Thyroid function should be monitored in patients receiving
prolonged treatment with octreotide.
Caution in females of child-bearing potential. Patients should be advised to use
adequate contraception. Use in pregnant women only under compelling
circumstances. Do not breast-feed during treatment.
Adverse Events: The most commonly reported adverse reactions in clinical trials
were diarrhea, abdominal pain, nausea, flatulence, headache, cholelithiasis,
hyperglycemia and constipation. Other commonly reported adverse reactions were
dizziness, localized pain, biliary sludge, thyroid dysfunction (e.g., decreased
thyroid stimulating hormone [TSH], decreased Total T4, and decreased Free T4),
loose stools, impaired glucose tolerance, vomiting, asthenia, and hypoglycemia.
In rare instances, gastrointestinal side effects may resemble acute intestinal
obstruction, with progressive abdominal distension, severe epigastric pain,
abdominal tenderness and guarding. In very rare instances, acute pancreatitis
has been reported within the first hours or days of treatment and resolved on
withdrawal of the drug. Cholelithiasis-induced pancreatitis has been reported on
long-term treatment. ECG changes have been observed especially in patients with
underlying cardiac diseases. Post-marketing adverse reactions include:
anaphylaxis, allergy/hypersensitivity reactions, urticaria, acute pancreatitis,
acute hepatitis without cholestasis, cholestatic hepatitis, cholestasis,
jaundice, cholestatic jaundice, arrhythmia, increased alkaline phosphatase
levels, and increased gamma glutamyl transferase levels.
About Camurus
Camurus is a Swedish research-based pharmaceutical company committed to
developing and commercialising innovative and differentiated medicines for the
treatment of severe and chronic conditions. New drug products with best-in-class
potential are conceived based on the proprietary FluidCrystal® drug delivery
technologies and an extensive R&D expertise. Camurus’ clinical pipeline includes
products for treatment of cancer, endocrine diseases, pain and addiction,
developed in-house and in collaboration with international pharmaceutical
companies. The company’s shares are listed on Nasdaq Stockholm under the ticker
“CAMX”. For more information, visit www.camurus.com.
For more information
Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com
Rein Piir, VP Investor Relations
Tel. +46 (0)70 853 72 92
ir@camurus.com
The information was submitted for publication at 8.00 a.m. on 12 July 2016.
*Sandostatin® LAR® is a registered trademark of Novartis AG.
