Petach Tikva, Israel, December 10, 2012. PolyPid Ltd., a biotechnology company and developer of the PolyPid drug delivery nanotechnology platform, announced today positive preliminary results of a first-in-man clinical trial with its BonyPid™ product. In the study, BonyPid™ demonstrated a clear, positive signal of effect in bone recovery processes, following its early implantation onto the bone void fractures performed in the first surgical procedure.
BonyPid™ is a combined drug and medical device product integrating bone filler and a substantial antibiotic release platform. The bone filler is resorbed and replaced by the bone during healing process. The antibiotic release rate is controlled by PolyPid's drug delivery platform over a prolonged period of several weeks, allowing eradication or prevention of bone infections. The prolonged and sustained antibacterial activity, concomitantly with the bone osteoconductive activity exerted by the bone filler, contributes to early and successful bone healing.
The clinical trial was conducted in 16 males and females, aged 18-70, who experienced major trauma associated with severely open long-bone fractures. Upon administration, patients were treated according to the hospital standard of care treatment. BonyPid™ was implanted in the first surgical procedure, immediately after irrigation, debridement and bone fracture fixation.
"The preliminary results clearly demonstrated that BonyPid™ significantly reduced or prevented bone infection, and facilitated bone recovery. In addition, BonyPid™ enabled one surgical procedure and immediate closure of the open wound in most cases," said Dr. Noam Emanuel, PolyPid's CTO.
"Open long-bone fractures are mainly associated with high energy, often caused by car accidents, fall from a height, as well as combat injuries. These injuries may be associated with severe infections of the fractured bones, which prevent their successful healing, and may lead to prolonged and severe dysfunction as well as high amputation rate," said Prof. David Segal, former head of the Orthopedic Surgery Department, Hadassah Medical Center, Jerusalem, and previously the head of Orthopedic Surgery, Boston University School of Medicine, Boston, MA.
In addition to suffering and harm caused to open fracture victims, health systems incur high financial losses, due to the large number of repeated surgeries requiring prolonged hospitalizations and co-morbidities associated with poor outcomes.
PolyPid Ltd.'s main technology platform (also named PolyPid) is a family of innovative drug carriers, based on the fusion between polymers and lipids. Once implanted into the body, the platform enables controlled and constant release of drugs over very long periods of time. PolyPid Ltd.'s proprietary revolutionary platform is protected by a series of patents, and is adaptable to a wide variety of drugs: small molecules such as antibiotics and anti-inflammatory drugs, peptides, proteins, and also can be used for the administration of drugs based on nucleic acids (DNA and RNA). In addition, the platform technology can release combinations of all the aforesaid drugs.
PolyPid makes it possible to determine, in advance, the desired release rate of the drug as well as the optimal duration, which may last up to several months. Thus, it is possible to adapt PolyPid's nanotechnology platform to a wide variety of medical applications and indications, including orthopedics, cancer, urology and more.
About PolyPid Ltd.
Founded in 2008 and located in Israel, PolyPid Ltd. is a privately held, development stage company that has developed a platform enabling a controlled and prolonged release of any active pharmaceutical ingredient (API). PolyPid’s technology combines polymers and lipids, enabling small-and-large API entrapment in degradation and hydration protected environments, regardless of their chemical or physical characteristics. PolyPid's technology allows the release of the API from the reservoir at pre-determined rates of up to several months, with a constant release rate. The flexibility of this innovative technology enables local administration of compounds across numerous therapeutic classes for several applications. PolyPid Ltd. is owned by the founders, private investors and Xenia Venture Capital.
For more information about PolyPid Ltd, visit www.polypid.com
Kanaan Public Relations