Trimesta (Oral Estriol)
Synthetic Biologics, Inc, a developer of synthetic biologics and innovative medicines for serious infections and diseases, announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,372,826 entitled, Estriol Therapy for Multiple Sclerosis and Other Autoimmune Diseases, to the Regents of the University of California which includes claims to the use of the Company's drug candidate, Trimesta™ (oral estriol), in combination with glatiramer acetate injection (Copaxone®). Copaxone® is the number one selling drug for multiple sclerosis with approximately $4 billion in annual sales. Currently marketed exclusively by Teva Pharmaceutical Industries Ltd., Copaxone® is expected to face generic competition as certain patent terms begin to expire in 2014. Through its wholly owned subsidiary, Synthetic Biologics holds the exclusive worldwide license to U.S. Patent 8,372,826 and 6,936,599 and pending patents for multiple sclerosis and other autoimmune diseases covering the uses of its drug candidate, Trimesta™.
Trimesta™ is currently being utilized in combination with Copaxone® in a randomized, double-blind, placebo-controlled Phase II clinical trial for the treatment of relapsing-remitting multiple sclerosis in women. Lead Principal investigator, Rhonda Voskuhl, M.D., Director, University of California, Los Angeles (UCLA) Multiple Sclerosis Program, UCLA Department of Neurology, along with investigators at 14 other centers in the U.S., are administering either Trimesta™ (8 milligrams orally per day) in combination with Copaxone® (20 milligrams per day), or a placebo plus Copaxone® to patients enrolled in the trial.
"The claims in this new patent further expand Synthetic Biologics' coverage of our proprietary oral estriol product candidate, Trimesta™, to include its use in combination with the leading FDA-approved multiple sclerosis drug, Copaxone®," stated Jeffrey Riley, Chief Executive Officer at Synthetic Biologics. "We look forward to reporting the clinical results of this combination therapy after the relapsing-remitting multiple sclerosis patients complete their two years of dosing and monitoring scheduled for January 2014."
The 164-patient relapsing-remitting multiple sclerosis trial is fully enrolled and it is anticipated that the last patient will complete their last visit during January 2014. The primary outcome measure for the study is the rate of relapse between the placebo and treated groups at two years, an accepted FDA-approvable endpoint in MS. The clinical trial is supported by grants exceeding $8 million, awarded by the National Multiple Sclerosis Society in partnership with the National Multiple Sclerosis Society's (NMSS) Southern California chapter, and the National Institutes of Health.
About Synthetic Biologics, Inc.
Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of product candidates for serious infections and diseases. Synthetic Biologics is developing a biologic for the prevention of C. difficile infection, and a series of monoclonal antibodies for the treatment of serious infectious diseases, including pertussis and Acinetobacter. The Company is also developing a synthetic DNA-based therapy for the treatment of pulmonary arterial hypertension. In addition, the Company is developing a drug candidate for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS.
Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd.
 Teva Pharmaceutical Industries Ltd. Form 20-F filed with the SEC for the year ended December 31, 2012.
Source: Rock Hill Herald Online Copyright The Herald 2013 (05/04/13)
Synthetic Biologics, Inc. announced today that patient enrollment has been completed in a Phase II clinical trial evaluating the efficacy and safety of Synthetic Biologics' proprietary oral formulation of estriol (Trimesta(TM)) for the treatment of relapsing-remitting multiple sclerosis (MS). With over $8 million in external grant funding awarded to date, this Trimesta clinical trial should be fully funded to its completion.
"The completion of patient enrollment into the Phase II Trimesta trial represents another important milestone for oral estriol and brings us one step closer to offering a new oral treatment option to patients with relapsing-remitting MS," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "As an oral therapy with a promising clinical profile, Trimesta is expected to be extremely well positioned to provide an important treatment option for this debilitating disease."
The randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial of Trimesta (oral estriol) for relapsing-remitting MS in women initially enrolled a total of 164 patients. At 15 sites in the United States, clinical investigators have been administering either oral Trimesta or matching placebo in addition to glatiramer acetate (Copaxone®), an FDA-approved therapy for MS, to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. MS patients are being dosed and monitored for two years.
The primary outcome measure for the study is the rate of relapse between the placebo and treated groups at two years, an accepted FDA-approvable endpoint in MS. Additional information regarding the relapsing-remitting MS clinical trial is available at http://www.clinicaltrials.gov/ct2/show/NCT00451204 .
Current sales of injectable disease-modifying therapies for MS are estimated at $8.9 billion annually. According to various reports, sales of oral disease-modifying therapies for MS, of which Trimesta(TM) if and when approved would be in such class, are anticipated to exceed $5 billion annually by 2017.
"We are pleased to complete the enrollment of a total of 164 patients in this landmark MS trial," said Rhonda Voskuhl, M.D., Director, University of California, Los Angeles (UCLA) Multiple Sclerosis Program, UCLA Department of Neurology, and lead Principal Investigator of the trial. "In the United States alone, over 200 people per week are diagnosed with MS, and approximately 70% of them are women. Typically, relapsing-remitting MS is distinguished from the other forms of MS by the relapses, or attacks of declining neurologic function, followed by periods of remission. With this trial evaluating oral estriol (Trimesta), we would expect to demonstrate a reduction in the rate of relapses in these MS patients."
About Trimesta (oral estriol)
Trimesta is Synthetic Biologics' proprietary drug candidate for the treatment of relapsing-remitting MS in women. Estriol has been approved and marketed for over 40 years throughout Europe and Asia for the treatment of post-menopausal hot flashes. It has never been approved by the FDA for any indication in the United States.
It has been scientifically documented that pregnant women with certain autoimmune diseases experience a spontaneous reduction of disease symptoms during pregnancy, particularly in the third trimester. The PRIMS (Pregnancy In Multiple Sclerosis) study, a landmark clinical study published in the New England Journal of Medicine followed 254 women with MS during 269 pregnancies, and for up to one year after delivery. The PRIMS study demonstrated that relapse rates were significantly reduced by 71 percent (p < 0.001) through the third trimester of pregnancy compared to pre-pregnancy-rates, and that relapse rates increased by 120 percent (p < 0.001) during the first three months after birth (post-partum) before returning to pre-pregnancy rates.
It has been hypothesized that the female hormone, estriol, produced by the placenta during pregnancy, plays a role in "fetal immune privilege," a process that prevents a mother's immune system from attacking and rejecting her fetus. Maternal levels of estriol increase in a linear fashion through the third trimester of pregnancy until birth, whereupon they abruptly return to low circulating levels. The anti-autoimmune effects of estriol may also be responsible for the beneficial effects of pregnancy on MS.
Rhonda Voskuhl, M.D., has found that levels of estriol equivalent to pregnancy have potent immunomodulatory effects on MS. Dr. Voskuhl has further shown in a small number of non-pregnant female MS patients that estriol may have a therapeutic benefit by regulating the immune system and thus reducing the relapse rates, similar to the response seen in MS patients during pregnancy.
Source: PR Newswire Copyright (C) 2012 PR Newswire (14/03/12)
Adeona Pharmaceuticals has begun the Phase II study of its Trimesta drug, used for the treatment of cognitive dysfunction in multiple sclerosis (MS).
Trimesta is an oral estriol designed for treating relapsing-remitting MS and for cognitive dysfunction in MS, both in female patients, and has been approved throughout Europe and Asia to treat post-menopausal symptoms.
The Phase II trial is a randomized double-blind placebo-controlled study expected to enroll 64 relapsing-remitting or secondary-progressive female MS patients.
In the study, the primary objective is the average change in Paced Auditory Serial Addition Test (PASAT) scores at 12 months between each group, and secondary endpoints include relapse rates, whole brain atrophy determined by MRI and safety.
Principal investigator of the study Rhonda Voskuhl said the aim of this trial is to address the unmet need for MS patients, improving a person's mental sharpness and ability to continue working.
Currently, another 15-center Phase II randomized double-blind placebo-controlled clinical trial is underway, intended to demonstrate Trimesta's ability to reduce relapse rates in women with the relapsing-remitting form of MS.
Source: PBR © PBR 2012 (20/01/12)