Phase I/Ib Trial of Single Agent PBF-999 in Solid Tumour Advanced Cancer
Multicentric phase I (dose escalation plus expansion) clinical trial of PBF-999 in patients with immunotherapy naïve and pretreated solid tumors to evaluate the safety, tolerability and preliminary efficacy of the compound
Randomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-999 (160 mg and 320 mg) "After Multiple Oral Doses" in Healthy Volunteers
To assess the safety and tolerability of five doses of PBF-999 (160 mg and 320mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.
Palobiofarma’s PBF-999 has been developed to treat solid tumours such as colon cancer. Credit: Nemeziya / Shutterstock.com.
Spanish biopharmaceutical company
Palobiofarma has collaborated
with the Foundation for Prader Willi Research (FPWR) to develop its PBF-999 to treat Prader Willi syndrome (PWS).
The company has received a new venture philanthropy award as a convertible loan from FPWR.
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It intends to utilise the funding from FPWR to partially fund its ongoing Phase II clinical trial of PBF-999, a dual adenosine A2a receptor antagonist/phosphodiesterase 10 (PDE-10) inhibitor.
The PDE-10 inhibitor has been developed to treat ‘cold tumours,’ such as colon cancers. It has already been assessed in three clinical trials.
Following observations of an appetite-reducing effect using PBF-999, Palobiofarma designed a clinical trial to assess its efficacy and safety in reducing hyperphagia (excessive hunger) in PWS adults.
Palobiofarma CEO Dr Julio Castro stated: “We are excited to receive this funding from FPWR, which will enable us to continue our mission of developing a treatment to help patients with PWS.”
Led by Dr Assumpta Caixàs, the clinical trial is being conducted at the university hospital Parc Taulí in Sabadell, Spain.
FPWR executive director Susan Hedstrom stated: “Effective treatments for PWS hyperphagia are sorely needed and we are pleased to support Palobiofarma’s efforts on this front.”
In 2018, Palobiofarma
commenced recruitment of participants
for a Phase I clinical trial of PBF-999 in patients with solid tumours.
Conducted at the Vall D Hebron hospital in Barcelona, Spain, the trial was designed to assess the tolerability and safety of PBF-999.
[Pamplona, Covina] - The Foundation for Prader Willi Research (FPWR) has provided a new venture philanthropy award, in the form of a convertible loan, to Palobiofarma S.L., a Spanish biopharmaceutical company focused on developing innovative treatments for serious diseases. Palobiofarma has a robust pipeline of promising drug candidates that are currently undergoing clinical development for a range of diseases, including cancer, respiratory, and metabolic disorders supported by an experienced team.
FPWR’s philanthropic investment will be used to partially fund Palobiofarma's ongoing Phase 2 clinical trial to develop PBF-999 for the treatment of Prader Willi syndrome (PWS). PBF-999 is a phosphodiesterase 10 inhibitor that has been evaluated in three previous clinical studies. Observations of an appetite-reducing effect have led Palobiofarma to design a clinical study to test this compound in adults with PWS to evaluate safety and efficacy in the reduction of hyperphagia (excessive hunger). The clinical study is being conducted in the University Hospital Parc Taulí in Sabadell, Spain under the leadership of Dra. Assumpta Caixàs.
"We are excited to receive this funding from FPWR, which will enable us to continue our mission of developing a treatment to help patients with PWS," said Dr. Julio Castro, CEO of Palobiofarma.
"Effective treatments for PWS hyperphagia are sorely needed and we are pleased to support Palobiofarma’s efforts on this front," said Susan Hedstrom, Executive Director of the Foundation for Prader-Willi Research.
The Foundation for Prader-Willi Research is a 501(c)(3) non-profit organization dedicated to eliminating the challenges of Prader-Willi syndrome through the advancement of research and therapeutic development. By providing funding and resources to companies like Palobiofarma, FPWR is helping to develop new treatments for people with PWS.