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
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, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Pierre Fabre & Array BioPharma Announce a 62% Observed OS at One Year from the Phase 3 BEACON CRC Safety Lead-In of the Combination of Encorafenib, Binimetinib and Cetuximab in BRAF-Mutant CRC at the ESMO GI Congress23.6.2018 14:00 | Tiedote
Not intended for UK- and US-based media Pierre Fabre and its partner Array BioPharma Inc. today announced updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAF V600E -mutant metastatic colorectal cancer (CRC). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO 20th World Congress on Gastrointestinal Cancer in Barcelona, Spain. The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines
Compelling Data for LONSURF® (trifluridine/tipiracil) in Metastatic Colorectal Cancer Presented at ESMO’s World Congress on Gastrointestinal Cancer by Servier and Taiho23.6.2018 11:10 | Tiedote
Servier and Taiho Pharmaceutical Co., Ltd. today announced that the TASCO-1 trial demonstrated promising results for LONSURF® (trifluridine/tipiracil) in combination with bevacizumab in patients with previously untreated metastatic colorectal cancer (mCRC) who are not suitable for intensive treatment, with a median progression-free survival (PFS) of 9.2 months (ranging from 7.6 to 11.5 months). A second non-comparative arm in the trial, evaluated the outcome of patients treated with the current standard of care of capecitabine in combination with bevacizumab. The median PFS of this arm was 7.8 months (ranging from 5.5 to 10.1 months). “Colorectal cancer is the third most common cancer in the world. While there has been some progress in treatment, there are still few options for patients with metastatic disease who are not suitable for intensive treatment,” said Professor Eric Van Cutsem, Head of Digestive Oncology at the University of Leuven, Belgium. “These compelling results suggest
Softomotive and Accelerate RPA Partner to Help Enterprises Achieve Faster Time to Value from RPA22.6.2018 18:13 | Tiedote
Softomotive, a world–class Robotic Process Automation (RPA) technology provider offering best time to value and affordability for all sizes and types of enterprises, is pleased to announce a strategic partnership with AccelerateRPA, a high calibre professional services provider of trained and certified RPA Consultants within Robotic Process Automation. This partnership means that customers and end users of Softomotive’s software, will have additional knowledgeable and professional guidance available to help achieve significant value quickly from their investment in RPA. Companies who are looking to implement Softomotive’s RPA product suite (WinAutomation and ProcessRobot software) will now have direct access to AccelerateRPA’s highly skilled consultants and Developers. Further, AccelerateRPA has also become a licensed reseller of Softomotive’s products, offering customers a single point of contact for delivering both RPA software and services. Ashley Hudson, Director of AccelerateRPA,
Ascend Performance Materials Announces Price Increase for Intermediate Materials22.6.2018 17:00 | Tiedote
Ascend Performance Materials announced today a price increase for its intermediate materials. The price increase will take effect globally on July 1, 2018, and includes the following terms: Material Price Increase Terms Hexamethylene diamine (HMD) $0.17/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Acrylonitrile (AN) $0.20/lb. • As contracts allow. • Non-contract business – price determined on an order-by-order basis. Customers should contact their local sales representative for additional information. About Ascend Performance Materials Ascend Performance Materials is a global premium provider of high-quality plastics, fibers and chemicals and is the world’s largest integrated producer of PA66 resin. Headquartered in Houston, Texas, Ascend has eight global locations, including five fully-integrated manufacturing facilities located in the southeastern United States, all dedicated to the innovation and safe production of nylon 6,6. With
Different Countries, Different Customs: Get Ready for the Motorbike Holidays with Moto-tyres.co.uk22.6.2018 16:41 | Tiedote
Pack your bags, close the boot and get away on holiday? When you start your holidays on a motorcycle, you usually have to consider a few things more when getting ready for your trip. The right preparation is therefore a must. So that nothing stands in the way of a smooth journey, Moto-tyres.co.uk has put together some tips for your next trip. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180622005345/en/ Different countries, different customs: get ready for the motorbike holidays with Moto-tyres.co.uk (Photo: Business Wire) Whether a weekend trip or extended adventure, it all depends on the right equipment. Functional clothing, protectors and rain protection are a must on long trips. Wearing a suitable motorcycle helmet is a legal requirement almost everywhere. However, there are also very different rules and regulations for motorbike equipment and accessories depending on the destination, and you should familiarise yoursel
Boehringer Ingelheim bolsters biologics research and development with 230 million euro investment in new development center22.6.2018 15:00 | Tiedote
Today Boehringer Ingelheim announced a 230 million euro investment into a new Biologicals Development Center (BDC) at the company’s Research and Development site in Biberach, Germany during the foundation stone laying for the new center. “The BDC is another key building block supporting the company’s long-term strategy for increasing the pipeline’s share of biologicals. This is particularly driven by two of our core areas, immune oncology and immunology,” says Dr. Fridtjof Traulsen, Corporate Senior Vice President Development at Boehringer Ingelheim. “The share of new biological entities in Boehringer Ingelheim’s research pipeline has been consistently increasing over the past few years and has now reached forty percent.” The BDC will help to maximize synergies by integrating biologicals analytical and process development as well as manufacturing for clinical studies into one seamless unit, while at the same time increasing development capacity. Following a staggered launch beginning i
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