NEW YORK--(BUSINESS WIRE)--Izun Pharmaceuticals Corporation (“Izun”, “Company”, izunpharma.com), a clinical stage company focused on developing high efficacy products based on pharmaceutical compounds derived from botanical sources announced today that the FDA has approved the Company’s 510(k) application for Curasite Wound Care Hydrogel. Curasite is a proprietary topical combination of three botanical extracts: Centella asiatica, Echinacea purpurea and Sambucus nigra in a hydrogel base. The prescription indications approved for use include the treatment of:
- Diabetic foot ulcers
- Leg ulcers, including venous stasis ulcers, arterial ulcers and ulcers of mixed etiology
- Full and partial thickness pressure ulcers
- 1st and 2nd degree partial thickness burns.
The approved over-the-counter indications for use are:
- Minor abrasions
- Minor lacerations
- Minor cuts
- Minor scalds and burns.
Mechanistically, in part, Curasite with its hydrogel base and botanical ingredients increases the moisture content within and around the wound by donating water, which makes the product effective in protecting the wound and in assisting the debridement and desloughing process in dry necrotic wounds, while maintaining a moist wound environment for optimal wound healing.
General product claims include:
- Positioned as first-line therapy
- Twice weekly dosing provides greater patient convenience and less wound disturbance
- Easy to use in home care setting.
Curasite was developed using Izun’s proprietary botanical technology, which has been studied in over 600 patients in an array of clinical trials in the United States and abroad. Curasite is the third product approved for marketing in the United States using the Company’s technology.
It is recommended to apply Curasite to a cleansed wound two to three times weekly. The product can be used as long as needed provided signs of healing occur within four weeks of first application without adverse effects.
Curasite was approved in part due to an 82 patient, double blind, active-controlled study that was conducted over 12 weeks duration. For the first four weeks, patients with chronic diabetic foot ulcers that were present, on average, for more than 6 months, were randomized in double blind fashion to either Curasite or hydrogel base alone. Wound healing was evidenced beginning in week 1 in both groups but plateaued in the hydrogel base control group, whereas the Curasite-treated group exhibited highly significant and continual progressive improvement throughout this portion of the study, reaching an average of over 50% wound closure (p < 0.0001) at 4 weeks compared to baseline.
After this 4 week double blind portion of the study, patients from both groups were then treated with Curasite open-label for an additional eight weeks. Patients initially administered hydrogel base who then crossed over to Curasite treatment began to incrementally heal their wounds. Patients in the Curasite group who then continued on Curasite for a total of 12 weeks also saw progressive improvement. For both groups the average reduction in wound size was nearly 90% at twelve weeks. More than half of patients in the follow-up portion of the study reached complete wound closure at twelve weeks of therapy.
Jack V. Talley, Chief Executive Officer of Izun commented: “We are delighted that the FDA approved our application. Diabetic foot ulcers and many of the other cited indications are poorly served by current treatment modalities. The consequences of unhealed wounds in these patient populations can be tragic. Izun is evaluating marketing partners to assist in a timely commercialization of Curasite in the United States as soon as possible.”
Izun is applying its patented proprietary, botanically-based pharmaceutical technology in several areas of unmet medical need. These include a completed single blind study to treat atrophic vaginitis. Additionally, a study for the prevention of oral mucositis in solid tumor patients receiving chemotherapy and radiation has completed enrollment and results are expected in the second quarter of 2017.
About Izun Pharmaceuticals
Izun Pharmaceuticals is a US based clinical stage pharmaceutical company with a wholly owned R&D center in Israel. Izun’s technology platform allows it to develop botanical drugs by optimizing and purifying the extracted botanical compounds to yield polymolecular drug candidates. These patented products are designed to impact on multiple specific receptor targets. The main therapeutic focus is on agents that can reduce inflammation and accelerate healing. Izun is currently active in developing therapeutic products for a number of indications including: oral care, oncology support, wound care, women’s health care, gastrointestinal disease and dermatologic conditions. Izun uses the inherent advantage of the natural botanical sources to deliver robust clinical results with an excellent safety profile. Izun has received approval for a number of oral care products that are marketed.
Izun Disclosure Notice: This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical facts may be deemed forward looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “to,” “plan,” “expect,” “believe,” “anticipate,” “intend,” “could,” “should,” “would,” “estimate,” or “continue,” or the negative or other variations thereof or comparable terminology are intended to identify forward looking statements. Investors are cautioned that all forward looking statements involve risk and uncertainties which may cause results to differ materially from those set forth in the statements. Such risks and uncertainties include, but are not limited to the following: the success of research and development activities and the speed with which regulatory authorizations and product launches may be achieved; government regulation generally; competitive developments; the ability to successfully market products domestically and internationally; difficulties or delays in manufacturing or issues relating to manufacturing capacity; commercial obstacles to the successful introduction of brand products generally; legal defense costs, insurance expenses, settlement costs, and the risk of an adverse decision or settlement relating to product liability, patent protection, governmental investigations, and other legal proceedings; the Company’s ability to acquire and protect patents and other intellectual property both domestically and internationally; the absence of certainty regarding the receipt of required regulatory approval or the timing or terms of such approvals; any changes in business, political and economic conditions; business interruption due to hurricanes or other events outside of the Company’s control.
Investors are cautioned not to place reliance on these forward looking statements, which are valid only as of the date they were made. The Company undertakes no obligation to update or revise any forward looking statements to reflect new information or the occurrence of unanticipated events or otherwise, except as expressly required by law.
