- Phase IIa clinical trial evaluated Aurase Wound Gel in patients with venous leg ulcers
- Former Smith+Nephew CMO, Andy Weymann joins as Chairman to support progression of further Phase II clinical trials
CAMBRIDGE, UK I December 12, 2023 I SOLASCURE Ltd (SolasCure), a biotechnology company developing a hydrogel containing tarumase (provisional INN), a recombinant enzyme derived from maggots, and which aims to accelerate wound debridement and contribute to wound bed preparation & healing, today announced the results of its proof-of-concept, first-in-human, Phase IIa safety study. The CLEANVLU trial evaluated the Company’s first investigational product, Aurase Wound Gel, for use in chronic venous leg ulcer patients over 12 applications of the product (dosed every 3 days).
SolasCure’s CLEANVLU Phase IIa clinical trial observed a strong safety profile for Aurase Wound Gel, with no evidence of systemic availability, no antibody generation to the enzyme and no effects on systemic coagulation pathways. In addition, no local tolerability issues (erythema, oedema, induration, or bleeding) and no pain from application of the gel was observed. The trial also indicated a dose-dependent effect on wound debridement with higher concentrations of enzyme resulting in more complete debridement, a faster rate of debridement, and an improved wound healing trajectory. The study was performed at centres in the US, UK, and Hungary.
SolasCure’s Aurase Wound Gel, a hydrogel containing an enzyme cloned from medical maggots, aims to facilitate debridement, reduce bacterial biofilm, and promote wound bed preparation and healing. Aurase Wound Gel is due to enter further Phase II trials to further evaluate its efficacy across a larger and more diverse patient group than the Phase IIa study, with the positive safety data obtained from the Phase IIa trial allowing for higher concentrations of the gel to now be explored.
Chronic wounds are a huge unmet medical need with treatment costs accounting for approximately 1-3% of total healthcare expenditure in developed countries. With over 40 million chronic wounds requiring debridement each year globally, the need for better debridement, wound bed preparation and healing is a growing and urgent problem, currently without safe, pain-free, and effective solutions.
Strengthening SolasCure’s leadership team as it moves towards further Phase II clinical trials, medical expert Andy Weymann has been appointed as Chairman of the Board.
Andy Weymann M.D., newly appointed Chairman of the Board, SolasCure, said: “I am delighted to join the SolasCure team, especially at such an exciting phase of growth. The positive safety and proof-of-concept data from the Phase IIa trial represents a huge milestone for the Company, accelerating its mission to provide a disruptive wound care product that could significantly improve outcomes for patients with chronic wounds globally. I look forward to working alongside the team as we now focus on developing the efficacy of Aurase Wound Gel in subsequent Phase II trials.”
Andy Weymann is an orthopaedic surgeon with 25 years’ experience in the medical device and regenerative medicine industries. Andy has held several global executive and Board roles throughout his career, including Chief Medical Officer and Senior Vice President of Scientific, Clinical and Medical Affairs at Smith+Nephew. Andy completed his Masters in Human Medicine at the University of Zurich, Switzerland, an MBA at the Simon Business School, University of Rochester, NY, and his Board Program at Harvard, Boston, MA.
Rob Kirsner, M.D., PhD, Head of Medical Advisory Board at SolasCure, Chairman and Harvey Blank Professor of Dermatology at the University of Miami, added: “SolasCure’s Aurase Wound Gel is an innovative technology, harnessing an enzyme cloned from medical maggots to accelerate wound cleaning, and therefore healing. We have a shared vision to deliver a meaningful solution for patients with chronic wounds, and the positive data observed in the CLEANVLU Phase IIa trial brings us another step closer.”
Further validating SolasCure’s innovative approach to wound care, the Company was recently selected for the EIC Accelerator Horizon grant which recognises the potential impact the innovative technology could have on the lives of patients suffering from chronic wounds without adequate solutions.
For more information about SolasCure, please visit: https://solascure.com/.
SOURCE: SolasCure
Phase 1b DLBCL-001 study reinforces promising activity and combinability of golcadomide with R-CHOP in patients with previously untreated aggressive B-cell lymphoma
Phase 1/2 CC-99282-NHL-001 study demonstrates activity and combinability with rituximab in heavily pretreated patients with diffuse large B-cell lymphoma
PRINCETON, NJ, USA I December 11, 2023 IBristol Myers Squibb (NYSE: BMY) announced the results of two early studies evaluating combinations of potential first-in-class CELMoD™ agent golcadomide in non-Hodgkin lymphomas. These data are being presented in separate posters (#4459, #4496, #1631) at the 2023 American Society of Hematology (ASH) Annual Meeting from December 9-12.
“Golcadomide is a novel, oral CELMoD agent representing one of several compelling assets generated from our differentiated targeted protein degradation research platform,” said Michael Pourdehnad, M.D., senior vice president, Head of Early Clinical Development, Hematology, Oncology and Cell Therapy Development, Bristol Myers Squibb. “In the studies being presented at ASH 2023, golcadomide has shown potential warranting further evaluation in patients with first-line and previously treated large B-cell lymphomas. We are encouraged by the growing body of evidence for this purposefully designed lymphoma agent as we continue toward a registrational program.”
CC-220-DLBCL-001
In the dose expansion phase of this Phase 1b study, patients were randomized 1:1 to golcadomide at one of two recommended Phase 2 dose levels (DL) (DL-1: 0.2 mg day 1-7, n=35; DL1: 0.4 mg day 1-7, n=37) plus R-CHOP-21 for a fixed duration of 6 cycles. A total of 65 (83.3%) patients completed 6 cycles of the combination with 13 discontinuing treatment.
There were 71 patients evaluable for efficacy, and results showed:
- Overall response rate (ORR) at end of treatment rate was 84.5% in patients overall, with 87.9% of patients in the DL1 arm achieving a complete metabolic response (CMR) compared to 63.6% in the DL-1 arm.
- Minimal residual disease negativity at the end of treatment was achieved in 93% (14/15) of patients treated with 0.4 mg of golcadomide plus R-CHOP compared to 70% (7/10) treated with 0.2 mg of golcadomide plus R-CHOP.
- At both DL1 and DL-1, steady-state levels of golcadomide reduced Ikaros over 80%, to levels predicted to optimize tumor cell killing and to stimulate T and NK cells.
In the safety population (n=78), the majority of patients (98.7%) experienced at least one treatment-emergent adverse event (TEAE). Grade 3/4 TEAEs were primarily hematologic with neutropenia (89.7%), thrombocytopenia (42.3%) and anemia (32.1%) being the most common. Any grade febrile neutropenia was reported in 21.8% of patients. Median relative dose intensity of key R-CHOP components was maintained at >90%.
CC-99282-NHL-001
A separate poster detailed the efficacy and safety results from the dose expansion segment of a Phase 1/2 open-label study of two doses of golcadomide (0.2 mg, 0.4 mg) plus rituximab in relapsed/refractory patients with non-Hodgkin lymphoma. Patients were heavily pre-treated with a median number of 4 prior therapies (range 1-11), including 61% who had prior CAR T.
In patients evaluable for efficacy (n=26), the ORR was 42% (11/26) with 19% (5/26) achieving a complete response (CR). The median duration of response was 7.5 months (1.8-14.5). The ORR and CR rate was greater for patients in the 0.4 mg arm compared to the 0.2 arm (55% vs. 33% and 27% vs. 13%, respectively).
In the study, neutropenia was the most common TEAE of any grade, occurring in 50% of patients (22/44). Febrile neutropenia was observed in 2 patients, with 1 patient at each dose level. A total of 6 patients had serious adverse events with only pneumonia and pyrexia occurring in more than 1 patient (2 each). There were 4 deaths on treatment during the study with one considered related to the study treatment.
About Non-Hodgkin Lymphoma and Large B-Cell Lymphoma
Non-Hodgkin lymphoma (NHL) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.1 Diffuse large B-cell lymphoma (DLBCL) is a rapidly growing, aggressive disease and the most common form of non-Hodgkin lymphoma (NHL), accounting for one out of every three cases diagnosed.2 More than two-thirds of patients with DLBCL will not respond to or will relapse following second-line treatment. For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.3,4
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
SOURCE: Bristol Myers Squibb
Post Views: 814
- Phase IIa clinical trial evaluated Aurase Wound Gel in patients with venous leg ulcers
- Former Smith+Nephew CMO, Andy Weymann joins as Chairman to support progression of further Phase II clinical trials
CAMBRIDGE, UK I December 12, 2023 I SOLASCURE Ltd (SolasCure), a biotechnology company developing a hydrogel containing tarumase (provisional INN), a recombinant enzyme derived from maggots, and which aims to accelerate wound debridement and contribute to wound bed preparation & healing, today announced the results of its proof-of-concept, first-in-human, Phase IIa safety study. The CLEANVLU trial evaluated the Company’s first investigational product, Aurase Wound Gel, for use in chronic venous leg ulcer patients over 12 applications of the product (dosed every 3 days).
SolasCure’s CLEANVLU Phase IIa clinical trial observed a strong safety profile for Aurase Wound Gel, with no evidence of systemic availability, no antibody generation to the enzyme and no effects on systemic coagulation pathways. In addition, no local tolerability issues (erythema, oedema, induration, or bleeding) and no pain from application of the gel was observed. The trial also indicated a dose-dependent effect on wound debridement with higher concentrations of enzyme resulting in more complete debridement, a faster rate of debridement, and an improved wound healing trajectory. The study was performed at centres in the US, UK, and Hungary.
SolasCure’s Aurase Wound Gel, a hydrogel containing an enzyme cloned from medical maggots, aims to facilitate debridement, reduce bacterial biofilm, and promote wound bed preparation and healing. Aurase Wound Gel is due to enter further Phase II trials to further evaluate its efficacy across a larger and more diverse patient group than the Phase IIa study, with the positive safety data obtained from the Phase IIa trial allowing for higher concentrations of the gel to now be explored.
Chronic wounds are a huge unmet medical need with treatment costs accounting for approximately 1-3% of total healthcare expenditure in developed countries. With over 40 million chronic wounds requiring debridement each year globally, the need for better debridement, wound bed preparation and healing is a growing and urgent problem, currently without safe, pain-free, and effective solutions.
Strengthening SolasCure’s leadership team as it moves towards further Phase II clinical trials, medical expert Andy Weymann has been appointed as Chairman of the Board.
Andy Weymann M.D., newly appointed Chairman of the Board, SolasCure, said: “I am delighted to join the SolasCure team, especially at such an exciting phase of growth. The positive safety and proof-of-concept data from the Phase IIa trial represents a huge milestone for the Company, accelerating its mission to provide a disruptive wound care product that could significantly improve outcomes for patients with chronic wounds globally. I look forward to working alongside the team as we now focus on developing the efficacy of Aurase Wound Gel in subsequent Phase II trials.”
Andy Weymann is an orthopaedic surgeon with 25 years’ experience in the medical device and regenerative medicine industries. Andy has held several global executive and Board roles throughout his career, including Chief Medical Officer and Senior Vice President of Scientific, Clinical and Medical Affairs at Smith+Nephew. Andy completed his Masters in Human Medicine at the University of Zurich, Switzerland, an MBA at the Simon Business School, University of Rochester, NY, and his Board Program at Harvard, Boston, MA.
Rob Kirsner, M.D., PhD, Head of Medical Advisory Board at SolasCure, Chairman and Harvey Blank Professor of Dermatology at the University of Miami, added: “SolasCure’s Aurase Wound Gel is an innovative technology, harnessing an enzyme cloned from medical maggots to accelerate wound cleaning, and therefore healing. We have a shared vision to deliver a meaningful solution for patients with chronic wounds, and the positive data observed in the CLEANVLU Phase IIa trial brings us another step closer.”
Further validating SolasCure’s innovative approach to wound care, the Company was recently selected for the EIC Accelerator Horizon grant which recognises the potential impact the innovative technology could have on the lives of patients suffering from chronic wounds without adequate solutions.
For more information about SolasCure, please visit: https://solascure.com/.
SOURCE: SolasCure
Phase 1b DLBCL-001 study reinforces promising activity and combinability of golcadomide with R-CHOP in patients with previously untreated aggressive B-cell lymphoma
Phase 1/2 CC-99282-NHL-001 study demonstrates activity and combinability with rituximab in heavily pretreated patients with diffuse large B-cell lymphoma
PRINCETON, NJ, USA I December 11, 2023 IBristol Myers Squibb (NYSE: BMY) announced the results of two early studies evaluating combinations of potential first-in-class CELMoD™ agent golcadomide in non-Hodgkin lymphomas. These data are being presented in separate posters (#4459, #4496, #1631) at the 2023 American Society of Hematology (ASH) Annual Meeting from December 9-12.
“Golcadomide is a novel, oral CELMoD agent representing one of several compelling assets generated from our differentiated targeted protein degradation research platform,” said Michael Pourdehnad, M.D., senior vice president, Head of Early Clinical Development, Hematology, Oncology and Cell Therapy Development, Bristol Myers Squibb. “In the studies being presented at ASH 2023, golcadomide has shown potential warranting further evaluation in patients with first-line and previously treated large B-cell lymphomas. We are encouraged by the growing body of evidence for this purposefully designed lymphoma agent as we continue toward a registrational program.”
CC-220-DLBCL-001
In the dose expansion phase of this Phase 1b study, patients were randomized 1:1 to golcadomide at one of two recommended Phase 2 dose levels (DL) (DL-1: 0.2 mg day 1-7, n=35; DL1: 0.4 mg day 1-7, n=37) plus R-CHOP-21 for a fixed duration of 6 cycles. A total of 65 (83.3%) patients completed 6 cycles of the combination with 13 discontinuing treatment.
There were 71 patients evaluable for efficacy, and results showed:
- Overall response rate (ORR) at end of treatment rate was 84.5% in patients overall, with 87.9% of patients in the DL1 arm achieving a complete metabolic response (CMR) compared to 63.6% in the DL-1 arm.
- Minimal residual disease negativity at the end of treatment was achieved in 93% (14/15) of patients treated with 0.4 mg of golcadomide plus R-CHOP compared to 70% (7/10) treated with 0.2 mg of golcadomide plus R-CHOP.
- At both DL1 and DL-1, steady-state levels of golcadomide reduced Ikaros over 80%, to levels predicted to optimize tumor cell killing and to stimulate T and NK cells.
In the safety population (n=78), the majority of patients (98.7%) experienced at least one treatment-emergent adverse event (TEAE). Grade 3/4 TEAEs were primarily hematologic with neutropenia (89.7%), thrombocytopenia (42.3%) and anemia (32.1%) being the most common. Any grade febrile neutropenia was reported in 21.8% of patients. Median relative dose intensity of key R-CHOP components was maintained at >90%.
CC-99282-NHL-001
A separate poster detailed the efficacy and safety results from the dose expansion segment of a Phase 1/2 open-label study of two doses of golcadomide (0.2 mg, 0.4 mg) plus rituximab in relapsed/refractory patients with non-Hodgkin lymphoma. Patients were heavily pre-treated with a median number of 4 prior therapies (range 1-11), including 61% who had prior CAR T.
In patients evaluable for efficacy (n=26), the ORR was 42% (11/26) with 19% (5/26) achieving a complete response (CR). The median duration of response was 7.5 months (1.8-14.5). The ORR and CR rate was greater for patients in the 0.4 mg arm compared to the 0.2 arm (55% vs. 33% and 27% vs. 13%, respectively).
In the study, neutropenia was the most common TEAE of any grade, occurring in 50% of patients (22/44). Febrile neutropenia was observed in 2 patients, with 1 patient at each dose level. A total of 6 patients had serious adverse events with only pneumonia and pyrexia occurring in more than 1 patient (2 each). There were 4 deaths on treatment during the study with one considered related to the study treatment.
About Non-Hodgkin Lymphoma and Large B-Cell Lymphoma
Non-Hodgkin lymphoma (NHL) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.1 Diffuse large B-cell lymphoma (DLBCL) is a rapidly growing, aggressive disease and the most common form of non-Hodgkin lymphoma (NHL), accounting for one out of every three cases diagnosed.2 More than two-thirds of patients with DLBCL will not respond to or will relapse following second-line treatment. For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.3,4
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
SOURCE: Bristol Myers Squibb
Post Views: 814
