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Novadip Biosciences announced that the first US patient has been implanted with its investigational tissue regeneration product, NVD-003, in its Phase Ib/IIa clinical trial for Congenital Pseudarthrosis of Tibia (CPT), a rare pediatric bone condition. An autologous therapy derived from a patient’s own adipose stem cells, NVD-003 has the potential to accelerate healthy bone formation, restore mobility and avoid the need for amputation in children with CPT.
According to Novadip, this trial has now reached full enrollment; three patients have been enrolled in Belgium, two of whom have already been grafted with NVD-003. The company is actively planning the pivotal trial to support NVD-003’s approval by FDA.
Novadip also provided an update on NVD-X3, their allogeneic off-the-shelf matrix product, which entered clinical development this past summer with two parallel Phase Ib/IIa EU clinical trials. Enrollment in the first trial, for the treatment of a distal radius fracture following trauma, is near completion with nine of 10 patients already treated. In addition, the first patient has been treated in the second trial investigating NVD-X3 in spine fusion.
“We are excited by the progress of both of our programs in Europe and in US,” said Denis Dufrane, MD, PhD, CEO and founder of Novadip Biosciences. “We have demonstrated our capacity to manage multiple clinical trials in parallel as well as the robustness of our manufacturing platform for two different classes of cell-based and cell-derived products with the aim to deliver the best therapeutic agents to the patients.”
Novadip is developing NVD-003, an autologous therapy derived from adipose stem cells as a potential single treatment to save limbs and restore mobility in patients with congenital pseudoarthrosis of the tibia (CPT) and other rare pediatric bone disorders.
Novadip’s lead allogeneic product, NVD-X3, employs a matrix containing multiple bioactive factors that induce accelerated tissue healing. Designed as an off-the-shelf product, NVD-X3 can be shipped and stored at room temperature and offers superior intraoperative handling characteristics. Preclinical studies demonstrate that NVD-X3 offers superior bioactivity without the undesirable bone formation/resorption and inflammation observed with currently marketed bone engraftment products.
Source: Novadip Biosciences
Novadip Biosciences announced that the first US patient has been implanted with its investigational tissue regeneration product, NVD-003, in its Phase Ib/IIa clinical trial for Congenital Pseudarthrosis of Tibia (CPT), a rare pediatric bone condition. An autologous therapy derived from a patient’s own adipose stem cells, NVD-003 has the...
Novadip Biosciences announced that the first US patient has been implanted with its investigational tissue regeneration product, NVD-003, in its Phase Ib/IIa clinical trial for Congenital Pseudarthrosis of Tibia (CPT), a rare pediatric bone condition. An autologous therapy derived from a patient’s own adipose stem cells, NVD-003 has the potential to accelerate healthy bone formation, restore mobility and avoid the need for amputation in children with CPT.
According to Novadip, this trial has now reached full enrollment; three patients have been enrolled in Belgium, two of whom have already been grafted with NVD-003. The company is actively planning the pivotal trial to support NVD-003’s approval by FDA.
Novadip also provided an update on NVD-X3, their allogeneic off-the-shelf matrix product, which entered clinical development this past summer with two parallel Phase Ib/IIa EU clinical trials. Enrollment in the first trial, for the treatment of a distal radius fracture following trauma, is near completion with nine of 10 patients already treated. In addition, the first patient has been treated in the second trial investigating NVD-X3 in spine fusion.
“We are excited by the progress of both of our programs in Europe and in US,” said Denis Dufrane, MD, PhD, CEO and founder of Novadip Biosciences. “We have demonstrated our capacity to manage multiple clinical trials in parallel as well as the robustness of our manufacturing platform for two different classes of cell-based and cell-derived products with the aim to deliver the best therapeutic agents to the patients.”
Novadip is developing NVD-003, an autologous therapy derived from adipose stem cells as a potential single treatment to save limbs and restore mobility in patients with congenital pseudoarthrosis of the tibia (CPT) and other rare pediatric bone disorders.
Novadip’s lead allogeneic product, NVD-X3, employs a matrix containing multiple bioactive factors that induce accelerated tissue healing. Designed as an off-the-shelf product, NVD-X3 can be shipped and stored at room temperature and offers superior intraoperative handling characteristics. Preclinical studies demonstrate that NVD-X3 offers superior bioactivity without the undesirable bone formation/resorption and inflammation observed with currently marketed bone engraftment products.
Source: Novadip Biosciences
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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
