BETHESDA, Md., Oct. 21, 2013 (GLOBE NEWSWIRE) -- Sucampo AG, a subsidiary of Sucampo Pharmaceuticals, Inc. SCMP ("Sucampo"), today announced that its development partner, R-Tech Ueno, Ltd. (R-Tech), completed the enrollment on-time for a Phase 3 study of unoprostone isopropyl ophthalmic solution 0.15% for the treatment of retinitis pigmentosa (RP). R-Tech is conducting the clinical trial at 38 medical institutions in Japan.
The randomized, double-blind, placebo-controlled study will evaluate whether unoprostone isopropyl ophthalmic solution improves central retinal sensitivity as determined by Humphrey Field Analyzer (HFA) in patients with RP. The study's primary endpoint is the value of mean retinal sensitivity at four central points at one year, and the target sample size is 180 patients.
"There are no drugs currently approved for the treatment of RP anywhere in the world, and we believe that unoprostone isopropyl may be a promising candidate for this indication," said Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman, Chief Executive Officer and Chief Scientific Officer of Sucampo. "With the completion of the Phase 3 trial enrollment, R-Tech expects to complete this study by the end of 2014 with top-line results available in early 2015. Upon successful results, Sucampo intends to work with regulatory authorities in the United States and the European Union to determine the incremental data that will be necessary to form application packages for each region, and we look forward to the possibility of helping to meet the unmet needs of patients suffering from RP in these countries."
This study is being funded through an agreement established in February 2013 between R-Tech and the Japan Science and Technology Agency (JST), the governmental agency responsible for the implementation of science and technology policy in Japan (News Release - Feb. 4, 2013). Sucampo licensed from R-Tech the exclusive development and commercialization rights to unoprostone isopropyl globally except for Japan, Peoples Republic of China, Taiwan, and Korea. Both the U.S. Food and Drug Administration and the European Medicines Agency have granted orphan drug designation to unoprostone isopropyl for treatment of RP. Sucampo is not responsible for any development costs for the Phase 3 RP trial in Japan.
Retinitis pigmentosa is a genetic disease characterized by progressive, irreversible vision loss and decreasing visual acuity. As RP progresses, daily life becomes increasingly difficult. Blindness from all causes is among the most significant injuries to a patient's qualify of life and is a major driver of patient-based cost of care and lifestyle maintenance.
Further details of the study can be found at www.clinicaltrials.gov using the identifier NCT01786395.
About Unoprostone Isopropyl
Unoprostone isopropyl, a member of Sucampo's family of ion channel activators knows as prostones, is a synthetic docosanoid that may have a local effect on BK (Big Potassium) channels in the eye. BK channels are expressed in neural and contractile tissues like retina and vascular smooth muscle. A form of unoprostone isopropyl, with a trade name RESCULA®, is currently approved in the U.S. for use in patients with open-angle glaucoma or ocular hypertension.
Important Safety Information
Contraindications
RESCULA is contraindicated in patients with hypersensitivity to unoprostone isopropyl or any other ingredient in this product.
Warnings and precautions
Unoprostone isopropyl ophthalmic solution may gradually increase the pigmentation of the iris. The pigmentation change is believed to be due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. The long term effects of increased pigmentation are not known. Iris color changes seen with administration of unoprostone isopropyl ophthalmic solution may not be noticeable for several months to years. Treatment with RESCULA solution can be continued in patients who develop noticeably increased iris pigmentation. Patients who receive treatment with RESCULA should be informed of the possibility of increased pigmentation which is likely to be permanent.
Unoprostone isopropyl has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as unoprostone isopropyl is administered, but has been reported to be reversible upon discontinuation of unoprostone isopropyl ophthalmic solution in most patients.
RESCULA should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
Macular edema, including cystoid macular edema, has been reported. RESCULA should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
To minimize contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip. Keep bottle tightly closed when not in use. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.
RESCULA contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of solution and may be reinserted 15 minutes following its administration.
Adverse reactions
In clinical studies, ocular adverse events above 5% with use of RESCULA were burning/stinging (22.4%), burning/stinging upon drug instillation (18.6%), itching (13.2%), injection (11.6%), dry eyes (10.7%), foreign body sensation (9.0%), abnormal vision (8.2%), lacrimation disorder (6.2%) and eyelid disorder (5.8%). Approximately 10-14% of patients were observed to have an increase in the length of eyelashes (≥ 1mm) at 12 months, while 7% of patients were observed to have a decrease in the length of eyelashes. Corneal lesions were reported in 2.3% of patients.
The most frequently reported nonocular adverse event associated with the use of RESCULA in the clinical trials was flu-like syndrome, observed in approximately 6% of patients.
Use in specific populations
Pregnancy Category C - There are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, RESCULA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pediatric Use - the safety and efficacy of RESCULA in pediatric patients have not been established.
It is not known whether RESCULA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when RESCULA is administered to a nursing woman.
No overall differences in safety or effectiveness of RESCULA have been observed between elderly and other adult populations.
About Sucampo Pharmaceuticals, Inc.
Sucampo Pharmaceuticals, Inc., is focused on the discovery, development and commercialization of drugs based on ion channel activators knows as prostones. Discovered by the company's scientific founder, prostones are naturally occurring fatty acid metabolites with unique physiological activities. Sucampo has two marketed products – AMITIZA® and RESCULA – and a pipeline of prostone-based product candidates in clinical development. A global company, Sucampo is headquartered in Bethesda, Maryland, and has operations in the United Kingdom, Switzerland and Japan. For more information, please visit www.sucampo.com.
The Sucampo logo and the tagline, The Science of Innovation, are registered trademarks of Sucampo AG. RESCULA is a registered trademark of R-Tech Ueno, Ltd, and has been licensed to Sucampo AG.
About R-Tech Ueno, Ltd.
R-Tech Ueno is a publicly traded company listed on the JASDAQ exchange. It is a bio-venture company established in September 1989 for the purpose of R&D and marketing of drugs. Under the leadership of CEO Yukihiko Mashima, M.D., Ph.D., also a medical doctor, the company is developing new drugs on the theme "Physician-Oriented New Drug Innovation," targeting ophthalmologic and dermatologic diseases that previously had no effective therapeutic agent.
Sucampo Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, future financial and operating results, and other statements that are not historical facts. The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the impact of pharmaceutical industry regulation and health care legislation; Sucampo's ability to accurately predict future market conditions; dependence on the effectiveness of Sucampo's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Sucampo undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this presentation should be evaluated together with the many uncertainties that affect Sucampo's business, particularly those mentioned in the risk factors and cautionary statements in Sucampo's most recent Form 8-K and 10-K, which Sucampo incorporates by reference.
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