SAN DIEGO, CA, USA I December 4, 2014 I Apricus Biosciences, Inc. (APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the first patient has been enrolled in the Phase 2a clinical trial to evaluate RayVa(TM), Apricus’ product candidate for the treatment of Raynaud’s phenomenon secondary to scleroderma. RayVa combines alprostadil, a potent vasodilator, with Apricus’ proprietary permeation enhancer DDAIP.HCl, and is applied as an on-demand topical cream to affected extremities.
“Raynaud’s phenomenon is a near universal feature of scleroderma and causes pain, loss of hand function and is associated with fingertip ulcerations and loss of finger substance. A topical therapy such as RayVa has the ability to improve blood flow locally without systemic adverse effects and has the potential to alleviate symptoms and possibly prevent finger injury,” said Dr. James R. Seibold, an internationally recognized researcher in both scleroderma and Raynaud’s phenomenon and the Principal Member of Scleroderma Research Consultants, LLC.
The randomized, double-blind, placebo-controlled, Phase 2a clinical trial is expected to enroll approximately 45 patients with Raynaud’s phenomenon secondary to scleroderma. Each patient will receive applications of placebo and one of three different doses of RayVa, in a crossover design. This dose-ranging study will evaluate hemodynamics, skin temperature at the site of application, as measured by Laser Doppler and thermography, and symptomatic response following a standardized cold challenge. Other endpoints include safety and pharmacokinetic assessments.
“The dosing of the first patient in the RayVa Phase 2a clinical trial is a significant milestone for the Company, and importantly, for Raynaud’s patients, as we seek to address with RayVa, the symptoms associated with this chronic condition,” said Rich Pascoe, Chief Executive Officer. “Moreover, with the expected completion of the RayVa Phase 2a clinical trial, coupled with the anticipated start of the Phase 2b clinical trial of fispemifene in the first half of 2015 in men with secondary hypogonadism, Apricus is well positioned to drive value from its development-stage pipeline next year.”
About RayVa(TM)
RayVa is the proprietary name for Apricus’ product candidate for the treatment of Raynaud’s phenomenon associated with scleroderma (systemic sclerosis). The RayVa product combines alprostadil (prostaglandin E1), a potent vasodilator, with Apricus’ proprietary permeation enhancer, and is applied as an on-demand topical cream to affected extremities. Apricus initiated a Phase 2a clinical trial following promising animal data. RayVa may qualify for FDA Priority Review, given the unmet medical need and lack of approved products in the United States to treat secondary Raynaud’s phenomenon in patients with systemic sclerosis. Apricus anticipates submitting a New Drug Application for RayVa as early as 2017.
About Raynaud’s Phenomenon
Raynaud’s phenomenon (RP) is characterized by vasoconstriction in response to cold or stress of the hands and feet, resulting in reduced blood flow and the sensation of pain, which can be severe. Primary Raynaud’s phenomenon, which is not associated with an underlying medical condition, affects an estimated 3-5% of the US population.1 Secondary Raynaud’s phenomenon, is driven by an underlying medical condition, such as scleroderma, lupus or rheumatoid arthritis.2 Symptoms are severe and patients risk associated fingertip ulcerations. There are an estimated 100,000 adult patients with scleroderma in the US3, of which approximately 90% have secondary Raynaud’s phenomenon2. Overall, there are approximately 500,000 adult patients with secondary Raynaud’s phenomenon in the US.2, 4
Approximately 80% of scleroderma patients are women.5 Both primary and secondary Raynaud’s phenomenon disproportionately affects women.6 There is currently no approved therapy for Raynaud’s phenomenon in the United States, representing an unmet medical need.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus’ lead product, Vitaros(R), for the treatment of erectile dysfunction, is approved in Europe and Canada and commercialized in several countries in Europe. Apricus’ marketing partners for Vitaros include Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus’ second-generation Vitaros room temperature device is under development and is expected to enhance the product’s commercial value. Apricus recently commenced a Phase 2a trial for RayVa(TM), Apricus’ product candidate for the treatment of Raynaud’s phenomenon. Femprox(R), Apricus’ product candidate for the treatment of female sexual interest/arousal disorder, has successfully completed an approximately 400-subject proof-of-concept study. Apricus is currently seeking a strategic partner for Femprox. In October 2014, Apricus gained U.S. development and commercialization rights for fispemifene, a selective estrogen receptor modulator for the treatment of male secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms, in Phase 2 development.
SOURCE: Apricus Biosciences
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SAN DIEGO, CA, USA I December 4, 2014 I Apricus Biosciences, Inc. (APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the first patient has been enrolled in the Phase 2a clinical trial to evaluate RayVa(TM), Apricus’ product candidate for the treatment of Raynaud’s phenomenon secondary to scleroderma. RayVa combines alprostadil, a potent vasodilator, with Apricus’ proprietary permeation enhancer DDAIP.HCl, and is applied as an on-demand topical cream to affected extremities.
“Raynaud’s phenomenon is a near universal feature of scleroderma and causes pain, loss of hand function and is associated with fingertip ulcerations and loss of finger substance. A topical therapy such as RayVa has the ability to improve blood flow locally without systemic adverse effects and has the potential to alleviate symptoms and possibly prevent finger injury,” said Dr. James R. Seibold, an internationally recognized researcher in both scleroderma and Raynaud’s phenomenon and the Principal Member of Scleroderma Research Consultants, LLC.
The randomized, double-blind, placebo-controlled, Phase 2a clinical trial is expected to enroll approximately 45 patients with Raynaud’s phenomenon secondary to scleroderma. Each patient will receive applications of placebo and one of three different doses of RayVa, in a crossover design. This dose-ranging study will evaluate hemodynamics, skin temperature at the site of application, as measured by Laser Doppler and thermography, and symptomatic response following a standardized cold challenge. Other endpoints include safety and pharmacokinetic assessments.
“The dosing of the first patient in the RayVa Phase 2a clinical trial is a significant milestone for the Company, and importantly, for Raynaud’s patients, as we seek to address with RayVa, the symptoms associated with this chronic condition,” said Rich Pascoe, Chief Executive Officer. “Moreover, with the expected completion of the RayVa Phase 2a clinical trial, coupled with the anticipated start of the Phase 2b clinical trial of fispemifene in the first half of 2015 in men with secondary hypogonadism, Apricus is well positioned to drive value from its development-stage pipeline next year.”
About RayVa(TM)
RayVa is the proprietary name for Apricus’ product candidate for the treatment of Raynaud’s phenomenon associated with scleroderma (systemic sclerosis). The RayVa product combines alprostadil (prostaglandin E1), a potent vasodilator, with Apricus’ proprietary permeation enhancer, and is applied as an on-demand topical cream to affected extremities. Apricus initiated a Phase 2a clinical trial following promising animal data. RayVa may qualify for FDA Priority Review, given the unmet medical need and lack of approved products in the United States to treat secondary Raynaud’s phenomenon in patients with systemic sclerosis. Apricus anticipates submitting a New Drug Application for RayVa as early as 2017.
About Raynaud’s Phenomenon
Raynaud’s phenomenon (RP) is characterized by vasoconstriction in response to cold or stress of the hands and feet, resulting in reduced blood flow and the sensation of pain, which can be severe. Primary Raynaud’s phenomenon, which is not associated with an underlying medical condition, affects an estimated 3-5% of the US population.1 Secondary Raynaud’s phenomenon, is driven by an underlying medical condition, such as scleroderma, lupus or rheumatoid arthritis.2 Symptoms are severe and patients risk associated fingertip ulcerations. There are an estimated 100,000 adult patients with scleroderma in the US3, of which approximately 90% have secondary Raynaud’s phenomenon2. Overall, there are approximately 500,000 adult patients with secondary Raynaud’s phenomenon in the US.2, 4
Approximately 80% of scleroderma patients are women.5 Both primary and secondary Raynaud’s phenomenon disproportionately affects women.6 There is currently no approved therapy for Raynaud’s phenomenon in the United States, representing an unmet medical need.
About Apricus Biosciences, Inc.
Apricus Biosciences, Inc. (APRI) is a biopharmaceutical company advancing innovative medicines in urology and rheumatology. Apricus’ lead product, Vitaros(R), for the treatment of erectile dysfunction, is approved in Europe and Canada and commercialized in several countries in Europe. Apricus’ marketing partners for Vitaros include Abbott Laboratories Limited, Takeda Pharmaceuticals International GmbH, Hexal AG (Sandoz), Recordati Ireland Ltd. (Recordati S.p.A.), Bracco S.p.A. and Laboratoires Majorelle. Apricus’ second-generation Vitaros room temperature device is under development and is expected to enhance the product’s commercial value. Apricus recently commenced a Phase 2a trial for RayVa(TM), Apricus’ product candidate for the treatment of Raynaud’s phenomenon. Femprox(R), Apricus’ product candidate for the treatment of female sexual interest/arousal disorder, has successfully completed an approximately 400-subject proof-of-concept study. Apricus is currently seeking a strategic partner for Femprox. In October 2014, Apricus gained U.S. development and commercialization rights for fispemifene, a selective estrogen receptor modulator for the treatment of male secondary hypogonadism, chronic prostatitis and lower urinary tract symptoms, in Phase 2 development.
SOURCE: Apricus Biosciences
Post Views: 30
