BioTime Announces First Patient In U.S. Clinical Trial Treated For Facial Volume Deficit
Published: Oct 11, 2017
- First investigator-led trial of Premvia in U.S. for cosmetic use
- Clinical trial being conducted by Dr. Aronowitz, a leading Beverly Hills-based Plastic Surgeon
ALAMEDA, Calif.--(BUSINESS WIRE)--BioTime, Inc. (NYSE American: BTX), a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases, today reported that an investigator-led clinical trial has successfully treated its first patient in a study of Premvia™ as a carrier for stromal vascular fraction cells (SVF) for the treatment of age-related volume loss in the face. This is the first clinical trial to study Premvia™ in a purely cosmetic application. Premvia™, which has 510(k) clearance in the U.S. for wound management, is expected to file for CE Mark in Europe under the name Renevia® for the treatment of facial lipoatrophy in HIV patients later this year.
The objective of this investigator-led study is to evaluate the safety and performance of Premvia™ as a carrier for autologous SVF in non-HIV patients. SVF cells are believed to contain fat tissue progenitors, and are prepared at the point of care from a lipoaspirate. This single-arm study is designed to evaluate 10 subjects who each receive a treatment of Premvia™ and SVF. The study’s primary endpoint is mean change in volume of each side of the face from baseline six months post treatment, with secondary endpoints being hemi-facial volume change at one, two, three and 12 months from baseline.
“I am encouraged by the results seen in the EU pivotal study. Premvia has the potential to address the limitations that we see with autologous fat transfer,” said Dr. Joel A. Aronowitz, a leading Beverly Hills-based plastic surgeon who is conducting the study. “My patients need additional options, and I am excited that Premvia may enhance fat transfer and could help provide long lasting, natural looking facial augmentation with higher volume retention.”
HIV-associated lipoatrophy is a severe form of lipoatrophy characterized by the pathological loss of body fat from under the skin. In an EU pivotal clinical trial, Renevia® met its primary endpoint, and treated patients retained approximately 100% of transplanted volume at six months, based on 3-D volume measurement of the implanted area. In addition to meeting the primary endpoint, BioTime announced that treated patients retained an average 70% of the transplanted volume at 12 months and 64% at 18 months. While only a small number of patients have been observed through 18 months, the results thus far are encouraging and the long-term performance exceeded management expectations. All Renevia® transplants were shown to be well tolerated and there were no device-related serious adverse events noted during this trial.
The data in the trial has encouraged BioTime to make plans to seek additional indications for Renevia®, such as cosmetic facial aesthetics. BioTime expects to file the CE mark application by the end of this year with possible approval and launch next year.
Renevia® is an investigational medical device that is being developed as an alternative for whole adipose tissue transfer (fat grafting) procedures. Renevia’s® hydrogel polymer network provides the requisite amino acid sequences for adipose stromal vascular cell attachment and may support proliferation, localization and adipogenic differentiation. Renevia® is part of the HyStem® hydrogel family of proprietary injectable matrices, which are designed to facilitate the survival and growth of transplanted cells.
Premvia™ Important Information
Premvia™ is indicated for the management of wounds including: partial-thickness, full-thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh’s surgery, post-laser surgery, podiatric wounds, wound dehiscence, abrasions, lacerations, second degree burns, skin tears, and draining wounds.
- Premvia is contraindicated for patients with severe allergies, indicated by a history of anaphylaxis or presence of multiple severe allergies.
- Premvia is specifically contraindicated for patients with known allergies to products containing either hyaluronan or collagen derivatives.
- Premvia is not indicated for use in third degree burns.
Important Safety Information
- Complications that may arise from wound management products may include: infection, chronic inflammation, allergic reaction, excessive redness, pain, or swelling. If any of these complications are present, product should be removed from the wound area.
- Federal law restricts this device to sale by or on the order of a physician or practitioner.
- Only the vial contents are sterile – outside of vials are not sterile.
- Do not add additional components or additives to Premvia™.
About BioTime, Inc.
BioTime is a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases. The Company’s current clinical programs are targeting three primary sectors, aesthetics, ophthalmology and cell and drug delivery. Its clinical programs are based on two platform technologies: pluripotent cells, which can become any type of cell in the human body, and cell/drug delivery. Renevia®, a cell delivery product, met its primary endpoint in an EU pivotal clinical trial for the treatment of facial lipoatrophy in HIV patients earlier this year. Submission for approval of Renevia® in the EU is expected later this year, with possible approval and commercial launch in 2018. OpRegen®, a retinal pigment epithelium transplant therapy, is in a Phase I/IIa multicenter trial for the treatment of dry age-related macular degeneration, the leading cause of blindness in developing countries. BioTime also has significant equity holdings in two publicly traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte Corporation (NYSE American: OCX), and one private company, AgeX Therapeutics, Inc.
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Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Statements pertaining to product technology, clinical development, regulatory approval timelines, the success of potential cosmetic applications and potential opportunities for BioTime, Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of its Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. BioTime specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.