Business Wire

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

Del

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

Zephyr Endobronchial Valves Improve Breathing, Quality of Life and Activity for Severe Emphysema Patients in US Pivotal Trial22.5.2018 17:19Pressemelding

Pulmonx® Corp. today announced positive one-year results from the U.S. LIBERATE pivotal trial of the Zephyr® Endobronchial Valve, a minimally-invasive treatment for severe emphysema, an advanced form of chronic obstructive pulmonary disease (COPD). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180522006139/en/ Zephyr Endobronchial Valves (Photo: Business Wire) “The LIBERATE Study definitively proves that Zephyr Valves offer clinically meaningful improvements in three important areas for patients – the ability to breathe better, be more active, and enjoy an improved quality of life,” said the study’s lead investigator, Gerard Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University. He continued, “All primary and secondary endpoints were met, with Zephyr Valve treatment showing significant improvement for patients across multiple measures of breathing a

Seoul Semiconductor Announces the Availability of a Series of AC LED Modules22.5.2018 16:03Pressemelding

Seoul Semiconductor, a leading global innovator of LED products and technology, announces a comprehensive series of AC LED modules that use the company’s patented Acrich AC LED technology. The modules are offered in designs from 200 to 10,000 lumens in round, rectangular and linear formats. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180522006054/en/ Seoul Semiconductor Announces the Availability of a Series of AC LED Modules (Photo: Business Wire) These AC modules integrate Seoul Semiconductor’s patented Acrich AC driver technology with the company’s advanced LEDs, enabling the design of compact light fixtures with superior lighting performance, making these modules ideal for a wide range of lighting applications. “Lighting designers who are looking to significantly reduce the size, weight, and volume of their luminaire designs can select one of our standard round, rectangular, or linear AC module designs to develop a co

Medicortex Finland Announces Agreement with Pro-Lab22.5.2018 13:58Pressemelding

Medicortex Finland Oy announces that it has entered into an agreement with a Canadian company Pro-Lab Diagnostics Inc. Pro-Lab will be responsible for the regulatory process and registration of the ProbTBI™ brain injury detection kit in Canada and UK. Following a brain injury, the diagnostic test will detect in urine and saliva a unique brain injury biomarker which has been discovered and characterized by Medicortex. The agreement gives Pro-Lab exclusive rights for sales in the UK and Canada from which Medicortex will receive royalties. The agreement between the parties is confidential and no other details about the content of the agreement are disclosed. Pro-Lab will be responsible for the clinical validation of the kit prior to the commercial launch in the territories. In addition to the licensing agreement, the parties intend to initiate a development collaboration, the details of which are being discussed currently. “We are very proud that Pro-Lab Diagnostics has chosen to cooperat

ResMed Studies Show Remote Monitoring and Automated Resupply Improve Adherence to PAP Therapy22.5.2018 12:55Pressemelding

Remote patient monitoring and resupply programs have been shown to improve patient adherence to positive airway pressure (PAP) therapy, according to two separate studies presented by ResMed (NYSE: RMD, ASX: RMD) this week at the ATS 2018 International Conference. Remote monitoring boosts compliance In the first study, medXcloud, a ResMed-assembled group of healthcare key opinion leaders, examined de-identified data of more than 2.6 million U.S. PAP users from ResMed’s world-leading remote monitoring network, AirView. Using this big data approach, researchers observed excellent adherence among patients initiating PAP therapy: 75 percent achieved the CMS compliance threshold.* This rate compares very favorably with that of non-cloud-connected PAP therapy and other chronic medical therapies – both around 50 percent. Plus, the large sample suggests that the findings are generalizable and likely to reflect real-world clinical care. Resupply program boosts long-term compliance In a separate

FLIR Launches Radar and Thermal Products for Border Patrol and the Dismounted Warfighter22.5.2018 12:00Pressemelding

FLIR Systems, Inc. (NASDAQ: FLIR) today announced the availability of three products for use by global militaries and government agencies including border patrol agents. These products include two FLIR Ranger® mid-range panel radars, one with airborne drone and ground target detection, and the Recon® V UltraLite thermal monocular. The products, unveiled at the Special Operations Forces Industry Conference (SOFIC) 2018 in Tampa, Florida, are part of FLIR’s Soldier Solutions family and demonstrate the company’s commitment to deliver the most advanced equipment to armed services personnel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180522005421/en/ FLIR Ranger R8SS-3D drone-detecting radar can detect over 500 threats and their exact locations simultaneously (Photo: Business Wire) The FLIR Ranger R8SS-3D and R8SS radars, part of FLIR Ranger family of radars, offer mid-range detection capability for both fixed-based installat

Phil Brakewell Set to Lead WilsonHCG's Executive Search Efforts Across EMEA; Forbes Ranks WilsonHCG Among Best Executive Recruiting Firms22.5.2018 12:00Pressemelding

WilsonHCG, global leader and premium provider of innovative talent solutions, further expands its Executive Search division with the appointment of Director Phil Brakewell. Phil, who brings more than 14 years of talent acquisition leadership experience and most recently served as Head of Executive Search for ResourceBank, will be responsible for leading WilsonHCG’s efforts in the EMEA region. Prior to joining ResourceBank, Phil held consultant and resourcing leadership positions at Hitchenor Wakeford and The Caudwell Group – where he was responsible for developing the business internationally and drove innovative search solutions on behalf of a diverse range of clients. “WilsonHCG’s reputation speaks for itself,” said Phil. “WilsonHCG tailors its key service offerings – including Executive Search – to suit individual client needs, and I am thrilled to be part of such a dedicated, innovative team. The new Director position, covering EMEA, demonstrates our commitment to both Executive Se