Vidac Pharma Reports Positive Results from Phase 2a Proof-of-Concept Trial of VDA-1102 Ointment in Actinic Keratosis
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.
Shelly Majar, +972-2-5952090
Om Business Wire
(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
H.I.G. Europe Completes a Strategic Investment in Puerto de Indias Group21.2.2018 14:02 | Pressemelding
H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €20 billion of equity capital under management, announced that one of its affiliates has acquired a majority interest in Puerto de Indias Group (“Puerto de Indias” or the “Company”), with the goal of accelerating the Company’s growth initiatives and supporting its expansion into international markets. Headquartered in Seville, Spain, Puerto de Indias was founded by Jose Antonio and Francisco Rodriguez Fernandez, and has become in a short period of time the leading player in the Rosé Gin market in Spain. Puerto de Indias has in place an ambitious international expansion plan targeting the development of a commercial network in Europe, the U.S., and Latin America, as well as strategic alliances with strong international distributors. Leopoldo Reaño, Principal at H.I.G. Europe, commented on the transaction: “We are thrilled to have the opportunity to support the management team led by Jose Antonio an
Savi Adds Supply Chain Star Johannes Giloth to Advisory Board21.2.2018 13:02 | Pressemelding
Savi®, an innovator in big data/machine learning analytic solutions, supply chain management software, and sensor technology, today announced that Johannes Giloth has joined its board of advisers. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221005117/en/ Johannes Giloth (Photo: Business Wire) Giloth is a long-time leader in procurement, supply chain and manufacturing. He currently serves as Chief Procurement Officer and Senior Vice President of Operations at Nokia where he is in charge of every aspect of operations accountability worldwide — from demand planning to execution, procurement to manufacturing. “Johannes understands the impact the explosion of data will have on the supply chain. And his tremendous success as an innovative supply chain leader proves he knows what companies need to transform their supply chains,” said Rich Carlson, CEO of Savi Technology. “I’m thrilled to have him join Savi’s advisory board. As
Mavenir Unveils Its Industry First Mobile-Native UCaas Solution, Entering into a New UCC Market Category21.2.2018 13:00 | Pressemelding
Mavenir, a leader in mobile network transformation, today announced its industry first Mobile-Native Unified Communications and Collaboration as a Service (mUCaaS) solution, uniquely designed to address the specific mobility needs of SOHO and SMBs. Using mobile native wireless technologies while still supporting current communications desktop usage is a complete paradigm shift compared to traditional UCaaS offerings. Leveraging Mavenir’s expertise in mobile networks with Voice over LTE (VoLTE) and Rich Communication Services (RCS), the solution provides new recurring-revenue opportunities for mobile network operators (MNOs) while addressing the real business need for truly mobile communications for the workforce. MNOs are under pressure in the consumer market with flat growth, an intensive price war on voice and data plans, and fierce competition from OTT applications. The Enterprise market offers a better outlook with UCaaS telephony and messaging projecting growth of 15.2% CAGR1 2016
Medical Technology Leaders to Discuss Open Data During World Patient Safety, Science & Technology Summit21.2.2018 13:00 | Pressemelding
The medical technology field spans a multi-billion dollar market, and corporate competitiveness has long been viewed as the key to staying ahead. But Joe Kiani, Chairman, and CEO of the medical technology company, Masimo, is bringing fierce competitors together for the sake of patient safety. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221005514/en/ Joe Kiani, Founder and Chairman of the Patient Safety Movement Foundation, discusses the importance of open data and interoperability of medical devices. (Photo: Business Wire) As a strong advocate for patient safety, Kiani founded the Patient Safety Movement Foundation to stem the needless deaths that occur in hospitals every day through preventable medical error. The goal is zero preventable deaths by 2020. One of the ways to reach such an aggressive goal, says Kiani, is a concept called “interoperability” and he wants to use open data to create a “Patient Data Super Highw
Mavenir and ADVA Ensemble Partner to Deliver Enterprise LTE Solutions to Managed Service Providers and Enterprises21.2.2018 12:00 | Pressemelding
Mavenir, focused on transforming mobile network economics for Communications Service Providers, and Ensemble, a Division of ADVA Optical Networking, the leader in Edge NFV solutions, have partnered to provide a complete end-to-end solution for Enterprise LTE. The Enterprise LTE Solution empowers mobile network operators with a revenue-generating solution offering for businesses looking to replace outdated and expensive hardware-based wireless networks. Enterprise solutions require low cost white box architectures that are zero touch from an install perspective. To add complete LTE wireless connectivity to that solution allows the enterprise to install their own partial or complete LTE enterprise wireless that is capable of supporting CBRS and multicarrier solutions. The total global revenue for the private LTE addressable market in industrial and commercial IoT will reach $118.5 billion in 20231. Leveraging NFV as a platform for new and innovative applications, Ensemble and Mavenir hav
The Russian Export Center Will Be Presenting Innovative Russian Solutions at the Mobile World Congress in Barcelona for the First Time21.2.2018 11:21 | Pressemelding
The Russian Export Center will be introducing home-grown, Russian technology at the 2018 Mobile World Congress (MWC) in Barcelona for the first time. Seventeen Russian companies will showcase their unique, powerful and competitive solutions to a world audience from February 26th to March 1st, from the Russian Booth (Pavilion No. 6, booth 6H20 and 6I11). Information about Russian companies attending is available via the link below: https://drive.google.com/file/d/1pNZ5d8ZOSrC5Ltf_ro_oQVZoo2ylnWqY/view A special business program is organized for the Russian booth, to create opportunities for Russian companies to enter the international market and non-Russian companies to promote their business in Russia. We would like to welcome media and attendees to special events at the Russian Export Center exposition including: - A special session with the leading Russian newspaper "Kommersant", titled "New business opportunities in the digital age" involving Russian and foreign experts (February 26