Fibrocell Science, Inc., a gene therapy company focused on transformational autologous, cell-based therapies for skin and connective tissue diseases, today announced that the United States Food and Drug Administration (FDA) has granted allowance of its Investigational New Drug (IND) application for FCX-013 – one of the company’s gene therapy candidates – to begin clinical trials for the treatment of moderate to severe, localized scleroderma. 

 

“We are pleased the FDA has granted allowance of our IND for FCX-013 to begin clinical trials for the treatment of moderate to severe, localized scleroderma, offering patients the potential for relief from this chronic, painful, and debilitating disorder,” said John Maslowski, president and chief executive officer of Fibrocell. “With no FDA-approved therapies available, we look forward to advancing FCX-013 into the clinic.”

 

Localized scleroderma is a chronic, autoimmune skin disorder characterized by excessive collagen deposition resulting in thickening of the dermis and underlying tissue. Moderate to severe forms of localized scleroderma can result in significant morbidity, including pain, restricted motion, disfigurement, and developmental issues. FCX-013 is an autologous fibroblast genetically modified to express matrix metalloproteinase 1 (MMP-1) – a protein responsible for breaking down collagen. FCX-013 incorporates Intrexon Corporation’s proprietary RheoSwitch Therapeutic System®, a biologic switch activated by an orally administered compound (veledimex) to control protein expression.

 

Fibrocell expects to initiate enrollment for an open label, single arm, phase ½, clinical trial in the third quarter of 2018. The primary objective of the trial is to evaluate the safety of FCX-013. Secondary analyses consist of several fibrosis assessments including histology, skin scores, ultrasound, and additional measurements of targeted sclerotic lesions and control sites at various time points up to 16 weeks post-administration of FCX-013. Ten patients with any subtype of localized scleroderma are targeted for enrollment (approximately five patients per phase). The phase one portion will enroll adult patients. Dosing for the first three adult patients will be staggered prior to dosing the rest of the trial’s population. 

 

Fibrocell intends to include pediatric patients in the phase two portion of the trial after submission and approval of safety and activity data from the adult phase one patients to the FDA and the Data Safety Monitoring Board for the trial.

 

“The impact of localized scleroderma on patients, particularly children, can be devastating –affecting growth and mobility of their affected limbs,” said Alfred Lane, MD, chief medical advisor of Fibrocell and professor of dermatology and pediatrics (emeritus) at the Stanford University School of Medicine. “There are no approved therapies for localized scleroderma. Current treatments are aimed at impacting inflammation, but few options exist to treat the excessive collagen deposition in the skin and soft tissue, which may produce pain and limitation in motion and growth. With FCX-013, the goal is to bring relief to patients by targeting the abnormal collagen metabolism to improve skin function.”

 

The FDA has granted Orphan Drug designation to FCX-013 for the treatment of localized scleroderma. In addition, FCX-013 has been granted Rare Pediatric Disease designation for the treatment of moderate to severe, localized scleroderma. FCX-013 is being developed in collaboration with Intrexon Corporation, a leader in synthetic biology.

VB Cosmetics company, Dazzle Dry, announced that it is partnering with recognized, global non-profit, WeForest – an organization that engages with scientists, corporations, and other organizations to advance forest landscape restoration. WeForest will be working with Dazzle Dry specifically to help regenerate forests in the Khasi Hills of India.

 

“Dazzle Dry believes that beauty and wellness go hand in hand,” says VB Cosmetics Founder Dr. Vivian Valenty. “For us, partnering with WeForest to help communities in India’s Khasi Hills regenerate their forest was a natural fit. Now, every purchase our clients make doesn’t just give them healthier cosmetics, it gives us all a healthier planet.”

 

Through the newly launched partnership, Dazzle Dry will donate one new tree to WeForest for every purchase made on its site. Ultimately, with the assisted efforts of companies like Dazzle Dry, WeForest aims to restore the forests of the Khasi Hills and, in turn, support the communities that live there.

 

While this collaboration is expected to continue indefinitely, Dazzle Dry has also decided to kick-start its charitable efforts by releasing a specially-curated WeForest collection. Each purchase of these forest-inspired nail lacquers, including Breathe Free, You Rock, Spiritual Diva, Morning Dew, Dragonfly, and Me d’Forest Queen, will provide an additional tree to the WeForest project through the month of May.

 

To view the featured WeForest collection, visit dazzledry.com. For more information on Dazzle Dry’s partnership with WeForest, visit weforest.org/partner/dazzle-dry.

The Association of Holistic Skin Care Practitioners (AHSCP) will hold its 11th annual conference on Nov. 4 and 5 at Chicago’s Crowne Plaza O’Hare Hotel. It will feature extensive, hands-on learning opportunities and demonstrations, so registration will be limited this year. The AHSCP offers the latest protocols and trends in organic, non-invasive skin care, as well as continuing education for aestheticians and holistic skin care certification. Workshops and conferences sponsored by the AHSCP provide education on natural ingredients, demonstrations of European and Eastern methods for individualized skin care protocols, and networking opportunities. For more information, go to holisticskincarepractitioners.org or call 269-384-2170. 

Eminence Organics celebrates their largest annual business conference July 20 through 22. This dynamic, yearly event unites over 200 Eminence team-members from around the world for three days of education, knowledge sharing, and celebration. Held in Vancouver, British Columbia the conference is designed to celebrate company wins and galvanize growth for the next 12 months.

TNMakeMyDayBeautifulIn 2007, Make My Day Beautiful!®’s founder and CEO, Linda Litzinger Beck, and husband, Greg Beck, first became affiliates of The Barbara Sinatra Center For Abused Children, in Rancho Mirage, California. They experienced the Frank Sinatra Celebrity Invitational Golf Tournament weekend and visited The Center, which benefits from money raised at the annual (now 32 year old) event. Touring

 

The Center, they learned about the remarkable programs, counseling, and services provided for children and families in need. Learning that the skin care, makeup, and grooming products needed as part of the center’s Girls’ Self-Esteem Class were acquired “catch-as-catch-can,” Beck committed to design and gift custom, complete, age-appropriate kits of full-size products to accommodate the self-care teaching and post-classroom needs of each girl in the program.

 

Spring 2018 marks 10 consecutive years of fulfilling this commitment. In addition, the company became a supporting sponsor of multiple Sinatra Invitational Fashion Show/Luncheons and anniversary events, providing hundreds of personal gifts for each, as well as deluxe door prizes and silent auction gift boxes for Mrs. Sinatra’s guests. Though all involved are greatly saddened and missing the beautiful Barbara Sinatra, since her passing in 2017, her legacy lives on, perpetually, through the existence of The Center. Make My Day Beautiful!® is committed to supporting The Center in all ways possible.

TNSaltabilityFormer Hand & Stone Director of Training, Doug Elman, joins Saltability – a spa industry vendor providing quality Himalayan salt stone treatments and products for spas – as the company’s director of education. Elman will work to educate spa partners on Saltability treatments, developed by spa industry veteran Ann Brown, that offer a more environmentally friendly, healthier alternative to traditional stone massage.

Just in time to welcome spring, Sanctuary Spa at Sanctuary on Camelback Mountain Resort & Spa has completed a top-to-bottom refurbishment and expansion that has introduced a fresh new look and features throughout. An intimate retreat, the celebrated spa features separate women’s and men’s spas, with a total of 12 indoor and outdoor treatment rooms and a private, stone-walled outdoor treatment room called Sanctum. Sanctuary Spa’s inspired redesign is the work of interior designer Lynne Beyer. Mark Philp, of Allen + Philps Architects, is the project architect.

Bioelements professional skin care is excited to announce the creation of a new advanced aesthetics initiative for 2018. Bioelements Pop-Up Education will bring the skin care company’s sought-after advanced education to select aesthetics institutions across the country. The New Age Spa Institute (NASI), a fully accredited school in Illinois that teaches to the highest standards and was founded to provide state-of-the-art education, is the first Bioelements Pop-Up Education partner school.

 

“We are extremely honored, humbled, and pleased to be a Bioelements Pop-Up Education partner school and help bring innovative education to aspiring students,” said Monika Machej, president of NASI and a CIDESCO Diplomat. “After Bioelements founder Barbara Salomone became my mentor years ago, I began to blossom and it is my duty to live up to the expectations of her wisdom by pouring knowledge into students so that they give back.”

 

“Bioelements was built on education. It is the heart of everything we do,” said Teresa Stenzel, Bioelements’ director of education. “Bioelements Pop-Up Education will allow us to bring our advanced aesthetics insights, techniques, and trend expertise to countless new aestheticians. We could not be more excited with this new partnership with the New Age Spa Institute, a truly world class aesthetics institution.”

Make Scents Natural Spa Line is pleased to announce a partnership with The Spa Mart. Powered by a community of millions, The Spa Mart is a wholesale distributor exclusive to the spa, wellness, and salon and spa education industries. The spa distribution company, headquartered in Georgetown, Texas, is dedicated to creating solution-driven partnerships that develop a culture of giving, gratitude, and valuing people.

 

“We have similar business philosophies,” said Make Scents Natural Spa Line owner, Heather J. Kreider. “It’s a partnership we absolutely love – and are proud to share the news. … The Spa Mart is a phenomenal partner. Their philosophy to help companies and individuals reach their full potential speaks to our clients who desire curated products that respect the health and well-being of their bodies and the planet. It just makes sense.”

Tuesday, 29 May 2018 12:11

CA Botana Founder Passes Away

Industry leader and founder of CA Botana, Dr. Dieter Kuster, passed away unexpectedly at the beginning of March 2018. Kuster was affectionately known as the “Einstein of Emulsion Technology.” With glowing skin and not a wrinkle or line on his face, he was his own best example of his innovative skin care research, which resulted in many new or advanced products and treatments.

 

Kuster was young at heart, in appearance, and demeanor, but also in his business approach. Always the scientist, Kuster was continuously investigating new, or better, formulations. One of his breakthrough achievements was the development of the highly-acclaimed Molecular Penetrator Alphasomes, an advanced delivery system to increase product effectiveness. Other pioneering work included target-specific enzymes and superior peptide technology.

 

Throughout his more than 50 years in the cosmetic trade, he developed over 4,000 products. He conducted clinical trials and product testing and was an internationally sought out lecturer in his field. Kuster was published in numerous trade publications and was the subject of many magazine and newspaper articles.

 

Kuster’s life was an authentic success story. Time and again, he triumphed over hardship and sorrow. His optimistic spirit and can-do attitude kept him moving forward in life and business in a positive direction.

 

Kuster leaves behind an incredible legacy of personal and professional achievement. He will not be forgotten.

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