Business Wire

Vidac Pharma Reports Positive Results from Phase 2a Proof-of-Concept Trial of VDA-1102 Ointment in Actinic Keratosis

Jaa

Vidac Pharma, a clinical-stage dermatology- and oncology-focused biopharmaceutical company, today announced positive results from a Phase 2a Proof-of-Concept (POC) clinical trial for its investigational topical drug, VDA-1102 ointment, in subjects with actinic keratosis (AK), an early form of cutaneous squamous cell carcinoma (cSCC). These results establish VDA-1102 ointment as a potential first-in-class non-irritating treatment for AK.

According to Dr. Mark Lebwohl, Professor and Chairman of Dermatology at the Icahn School of Medicine at Mount Sinai and an investigator in this trial, "the results of this trial are exciting because, until now, all the treatments we have available for actinic keratoses are irritating. We need nonirritating AK treatments that don't cause crusting and scabbing on the face."

“There is a high unmet need for an effective treatment of actinic keratoses without unpleasant skin reactions. Based on the results of this first study, VDA-1102 ointment appears to successfully go in this direction," said Professor Kristian Reich, Founder of SkinflammationTM, Hamburg, Germany.

“This proof-of-concept study established VDA-1102 ointment's safety and tolerability, demonstrating that it is completely non-irritating,” said Dr. Chaim M. Brickman, Chief Medical Officer at Vidac. “The study also confirmed VDA-1102 ointment’s efficacy in AK and paves the way for a higher dose, longer duration confirmatory Phase 2b study, which is planned for 2018.”

The randomized, double-blind, placebo-controlled, parallel-cohort Phase 2a clinical trial investigated the efficacy, safety, tolerability, and pharmacokinetics of once-daily application of topical VDA-1102 ointment for 28 days in subjects with actinic keratosis on their face or scalp (25 cm2 treatment area with 4-8 discrete Grade 1 or 2 AK lesions at baseline). Study endpoints were evaluated on Day 56. The study enrolled 93 subjects, at 8 clinical sites in the U.S. and Israel. Subjects were randomized to three treatment cohorts (5%, or 10% VDA-1102 ointment, or placebo). The mean age of the enrolled subjects was 66.5 (ranging from 37 to 93 years), and the majority of subjects (75.3%; 70 subjects) were treated for AK lesions on the face.

Safety – There were no treatment-emergent serious adverse events (AEs) or severe AEs related to the study drug. None of the subjects on the active study drug withdrew consent, discontinued treatment, or applied an emollient to the treatment field. Only 2 treatment-emergent AEs were deemed related to the study drug in the active treatment arms. Both AEs were mild and occurred in the 5% treatment group; none were reported in the 10% group. There were no clinically significant findings in vital signs, physical examinations, clinical laboratory results, or ECGs.

Tolerability – VDA-1102 ointment treatment resulted in no local skin irritation as measured by a Local Skin Reaction (LSR) score that ranges from 0 to 4 for 9 possible findings including erythema, edema, scaling, itching, and pain. On this 36-point LSR scale, the mean maximal scores for the VDA-1102 ointment treatment groups were 1.1±2.0 and 0.9±1.5 for the 5% and 10% doses, respectively, compared to 0.8±1.3 in the placebo treatment group. There was no statistical difference in the mean composite LSRs between the three treatment groups at any time (p= 0.7821).

Efficacy –The primary efficacy endpoint of the study was reduction in the total number of AK lesions (of all Grades) in the treatment field on Day 56. The 10% VDA-1102 ointment demonstrated statistically significant reduction in the total number of AK lesions vs. placebo for subjects treated on their face (p=0.023; 70 subjects), showing 50% median reduction with 10% VDA-1102 ointment (mean 38.8%±36.4%) compared to a median reduction of 20% in the placebo group (mean 29.0%±32.5%). The mean reduction in AK lesion count was greater in the 10% VDA-1102 ointment group than in the placebo group for the combined face or scalp population as well (32.1%±34.1% and 27.8%±30.6%, respectively) although the difference was not statistically significant.

The 10% VDA-1102 ointment treatment also demonstrated a statistically significant (p=0.0004) effect in an additional efficacy endpoint, reduction in the number of the more advanced lesions (only Grade 2 or 3; not counting Grade 1 lesions) for subjects treated on their face, with a median reduction of 64.6% (mean 59.9%±38.6%) compared with a median reduction of 0% in the placebo group (mean 19.9%±72.0%). This effect was even more prominent in the Per-Protocol population (N=83) where the median reduction of Grade 2 (or 3) AK lesions on the face was 80% in the 10% VDA-1102 ointment group compared to a median reduction of 0% in the placebo group. Reduction in Grade 2 (or 3) AK lesions was also statistically significant in the combined face and scalp populations (p=0.029), demonstrating a median reduction of 56.3% for the 10% VDA-1102 ointment group (mean 53.1%±41.9%) compared to a 0% median reduction in the placebo group (mean 25.9%±69.8%).

No Grade 3 lesions developed during the study in the two VDA-1102 ointment treatment groups, while 2 subjects in the placebo treated groups developed at least one Grade 3 lesion, despite having no Grade 3 lesions at baseline. A confirmatory Phase 2b study for VDA-1102 ointment in AK is planned for 2018.

About VDA-1102 ointment

VDA-1102 is a novel, potent selective modulator of the VDAC/HK2 complex in cancer cells. The drug triggers the dissociation of HK2 (hexokinase 2) from mitochondrial VDAC (voltage dependent anion channel) leading, among other effects, to apoptosis and death of the malignant cells. The selective nature of VDAC/HK2 dissociation targets only cancer cells without affecting the surrounding healthy tissue. VDA-1102 is being developed as a topical ointment for treatment of actinic keratosis (AK), cutaneous squamous cell carcinoma (cSCC), and cutaneous T-cell lymphoma (CTCL). VDA-1102 ointment has successfully completed a Phase 2a proof-of-concept study in subjects with AK, demonstrating efficacy, safety, and tolerability. VDA-1102 is also being developed as an injectable for treatment of solid tumors.

About Actinic Keratosis

Actinic keratosis (AK) is one of the most common dermatologic conditions worldwide. It affects an estimated 58 million people in the United States alone. In 2015 the global AK market was estimated at $6.6 billion. This skin disease occurs predominantly in older males with fair skin and most often begins as a rough red patch on the face, scalp, and/or extremities that may progress to a thicker, scaly, and unsightly skin lesion. AK is considered by many as an early form of cSCC. Thus, treatment is most commonly recommended by physicians in order to prevent cSCC. Current therapies are inadequate and pose significant disadvantages to public health. The limited tolerability of current treatment options greatly decreases the willingness of patients to be treated, compliant, and/or retreated. AK is a chronic disease for which patients often require repeat treatments. As a result patients with this prevalent condition elect to avoid treatment, seeking medical help only later, after their lesions have become esthetically intolerable or have advanced to malignant cSCC tumors.

About Vidac Pharma

Vidac Pharma is an innovative clinical-stage oncology- and dermatology-focused pharmaceutical company, developing novel drugs to help people suffering from a range of diseases. Vidac’s breakthrough technology targets the VDAC/HK2 system that is unique to malignant cells. The mechanism-of-action of these drugs leads to selective apoptosis of cancer cells without affecting the surrounding healthy tissue, leading to well-tolerated and efficacious treatments. Vidac is developing VDA-1102 as a topical treatment for AK and other skin malignancies, and as a parenteral drug for treatment of solid tumors. For more information regarding Vidac Pharma, please visit www.vidacpharma.com.

Contact information

Vidac Pharma
Shelly Majar, +972-2-5952090
smajar@vidacpharma.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Global Game Exhibition 'G-STAR 2017' Ends with a Big Finale14.12.2017 03:00Tiedote

The global game exhibition ‘G-STAR 2017’ had attendees in 2,857 booths from 676 companies in 35 countries and was the largest ever held in history; amidst an enthusiastic response from industries and attendees it ended with a big finale. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171213005402/en/ G-STAR 2017 Public Area (Photo: Business Wire) ‘G-STAR 2017’ was hosted by the Korea Gaming Industry Association (K-GAMES) and managed by the G-STAR Organizing Committee and the Busan IT Industry Promotion Agency. It was held for four days from November 16 (Thursday) through November 19 (Sunday) at the Busan BEXCO. This was the 13th year for ‘G-STAR’, and it opened its doors to attendees with a variety of contents in an area approximately 55,300 square meters in size which included Exhib

IFF Declares Dividend for Fourth Quarter 201714.12.2017 00:15Tiedote

Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF), a leading innovator of sensory experiences that move the world, announced that its Board of Directors has declared a regular quarterly cash dividend of $0.69 per share of the Company’s common stock, payable on January 8, 2018 to shareholders of record as of December 29, 2017. Meet IFF International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris: IFF) is a leading innovator of sensorial experiences that move the world. At the heart of our company, we are fueled by a sense of discovery, constantly asking “what if?”. That passion for exploration drives us to co-create unique products that consumers taste, smell, or feel in fine fragrances and beauty, detergents and household goods, as well as beloved foods and beverages. Our 7,400 team members globally take a

Limelight Networks Enhances DDoS Security Services with Faster Mitigation of Malicious Website Attacks13.12.2017 22:18Tiedote

Limelight Networks, Inc. (Nasdaq: LLNW), a global leader in digital content delivery, today introduced new capabilities to its DDoS Attack Interceptor Service that provide high-capacity on-network scrubbing and a scalable range of protection measures for web infrastructure, with the ability to easily increase protection as security requirements change. Protecting websites from online attacks and cyber threats is one of the most pressing security challenges today. For example, data from Limelight’s State of Cybersecurity Report: SE Asia shows consumers are very concerned about the security of ecommerce sites, with 72 percent saying they have a negative opinion of a brand after hearing that it has suffered a cyberattack. In addition, 51 percent of online websites feel they are vulnerable to attacks that could have significant financial and b

Interactive Brokers Now Allowing Short Positions in Bitcoin Futures13.12.2017 20:15Tiedote

Interactive Brokers Group, Inc. (NASDAQ GS: IBKR), a global electronic brokerage firm, will now accept orders for short sales of Cboe Futures Exchange (CFE) Bitcoin futures that began trading on the IBKR platform on Sunday, December 10, 2017. Interactive Brokers requires margin of $40,000 per contract for short sales in CFE Bitcoin futures. Margin on long positions of CFE Bitcoin futures is currently $9,000. “The introduction of short sales was necessitated by the large premium of the January futures contract over the price at which Bitcoin trades on the physical venues,” said Interactive Brokers founder, Chairman and CEO Thomas Peterffy. Interactive Brokers requires customers who wish to trade Bitcoin futures to execute a special agreement acknowledging the risk inherent in the contract. Current and new clients can learn more about trading Bitcoin futures with IBKR a

Sunny Optics Officially Licenses ImmerVision Panomorph Lens Technology for Global Production13.12.2017 15:47Tiedote

ImmerVision, developer of exclusive and patented panomorph wide-angle imaging technology, is proud to announce that Sunny Optics (Zhongshan) Co., a subsidiary of Sunny Optical Technology (Group) Co. Ltd., a leading manufacturer of integrated optical components and products, has licensed panomorph lens technology for global production, and will deliver its first small form-factor panomorph high-resolution super-wide-angle lenses for smartphones and mobile devices in Q1 2018. Panomorph lens technology combines state-of-the-art optical design and advanced, optimized algorithms, including low-power dewarping, to produce high-resolution super-wide-angle images without distortion, even in low light conditions. Sunny Optical is the largest Chinese lens supplier for the most popular smartphone brands and OEM applications such as sports cameras, surveillance, 360 image capture, autom

Synacor Launches Enhancements to Zimbra Communications and Collaboration Suite13.12.2017 15:30Tiedote

Synacor Inc. (NASDAQ:SYNC) today announced the commercial launch of Zimbra 8.8. The easy-to-use collaboration platform comes with new user experience features such as Zimbra Drive for enterprise-level file sync and sharing and Zimbra Chat. The Network Edition features tech stack enhancements including real-time backup, ActiveSync across mobile and desktop, hierarchical storage management (HSM) that enables customers to move archival data to less expensive storage solutions, and improved delegated admin functionality. “Zimbra 8.8 is an exciting update for end users and technical decision makers,” said Marcus Teo, Vice President, Enterprise Sales & Marketing, Synacor. “Customers look to Zimbra for security, privacy and transparency through open code, extensibility, accessibility on multiple devices and deployment flexibility. This update builds on these tenets and incorporates enhancemen

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme