合一WH-1 Ointment與敷料(Aquacel(R) Hydrofiber(R))比較有機會獲FDA breakthrough therapy資格 ?! (待協商)

合一糖尿病藥 臨床三期將達陣 2015-05-06 05:04:33 經濟日報 記者黃文奇／台北報導中天生技集團董事長路孔明昨（5）日表示，目前華人疾病大宗為肝病（癌）、糖尿病併發症等，集團旗下合一（4743）的抗糖尿病足新藥ON101，有機會獲得美國食品藥物管理局（FDA）突破性療法資格，抗C肝、肝癌藥也將積極聚焦大陸市場。中天集團旗下新藥公司還包括泉盛，路孔明指出，合一糖尿病足部傷口潰爛的ON101，國內三期臨床有效收案百例以上，個案治癒比重遠超過現有藥物，突破50%。ON101臨床三期試驗年底可望完成，明年第4季有機會送件申請藥證，若以該產品在治療糖尿病足的表現，未來尋求FDA認定為突破性療法，有極大機會獲得此資格。泉盛目前的新藥還在人體臨床前階段，路孔明透露，在考慮資源配置與後續發展下，不排除對外授權。中天近十年來研發費用達13.8億元，共開發九個新藥產品，今年開發陸續有成果，路孔明指出，「最外的階段已經過去」，公司近五年合併營收複合成長率達39%，相較同業毫不遜色。

 

 

Evaluate the Efficacy and Safety of WH-1 Ointment for the Treatment of Chronic Diabetic Foot Ulcers

Primary Outcome Measures: The incidence of complete ulcer closure [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] The primary variable is the number of target ulcers healed in each group within 16 weeks. The primary efficacy outcome is the comparison of the incidence of complete healing of the target ulcer between the two treatment groups at the end of treatment. For the purpose of this study a complete healing will be defined as complete epithelialization which is maintained with no drainage for at least 2 weeks and is confirmed by a blinded assessor.

Secondary Outcome Measures: The time of healing rate [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] Time to complete ulcer healing, The time of the original healing will be taken as the time to healing. change in ulcer area [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] Percentage change in ulcer surface area from baseline 50% reduction in ulcer area [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ] Percentage of subjects with a 50% reduction of ulcer surface area Incidence of infection of the target ulcer [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Incidence of infection of the target ulcer

Estimated Enrollment:    212

Study Start Date: September 2012

Estimated Study Completion Date: September 2018

Estimated Primary Completion Date:  June 2018 (Final data collection date for primary outcome measure)

Experimental:

WH-1 ointment WH-1 ointment(1.25%),15g ointment per tube. Twice daily for up to 16 weeks.

Aquacel® Hydrofiber® dressing Aquacel® Hydrofiber® dressings will be changed daily, on alternate days or three times a week according to need, but not longer than 7 days.

 

 

Detailed Description: This trial is designed as a randomized, evaluator blinded, active-controlled, multi-center study comparing the efficacy and safety of WH-1 ointment and Aquacel® Hydrofiber® dressing in the treatment of diabetic foot ulcers. Independent evaluators who blinded to subjects' treatment will evaluate whether the wound has healed. Eligible subjects will be randomized to receive either WH-1 ointment or Aquacel® Hydrofiber® dressing in a 1:1 allocation. The study treatment will be applied to the selected ulcer for a maximum period of 16 weeks, until the wound/ulcer closure (wound size of 0) for two consecutive visits at least 2 weeks apart, or until the subject exited the study as treatment failure. After that, all subjects regardless of wound healing at the end of comparison period will be followed for 12 weeks to investigate durability. During the follow-up period, Aquacel® Hydrofiber® dressing will be applied for subjects who have unhealed or with recurrent wound. Each target ulcer with wound photographs for blind assessment will be monitored at each scheduled visit. One interim analysis is planned at around 50% of study information; the final analysis will be conducted at the end of the study.

AQUACEL® Ag dressing incorporating unique Hydrofiber® Technology with 1.2% (w/w) silver combines the favorable gelling characteristics of Hydrofiber®Technology with the broad-spectrum antimicrobial properties of ionic silver (Ag+). It is a versatile primary dressing indicated for moderate to highly exuding chronic and acute wounds where there is an infection* or an increased risk of infection. * when used in a comprehensive protocol of care. Also available in ribbon form, with stich bonding for added strength.

 

FDA breakthrough therapy: A drug that is intended to treat a serious condition AND preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies