Over a week ago | ||||
PolyPid announced… PolyPid announced preclinical data from its OncoPLEX intra-tumoral cancer therapy program. OncoPLEX utilizes the Company's novel PLEX technology to provide prolonged and controlled local exposure to docetaxel, one of the most widely used chemotherapy agents, in the intra-operative tumor resection setting. OncoPLEX is designed for the delivery of sustained, significant concentrations of docetaxel locally within the tumor site for a few weeks, potentially reducing local tumor recurrence and tumor metastatic spreading. In a syngeneic mouse model for solid tumors of colon carcinoma, a single local application of OncoPLEX at the intra-operative setting post tumor resection compared to the group treated with six cycles of systemic docetaxel treatment with 2-4 days gap between cycles, generated the following key results: OncoPLEX arm showed 25% overall tumor recurrence at the end of the study compared to 75% in the systemic treatment arm, and 100% in the untreated control arm. OncoPLEX arm demonstrated 75% overall tumor free survival at the end of the study, compared to 25% in the systemic treatment arm, and 0% in the untreated control arm. OncoPLEX arm demonstrated 75% overall survival at the end of the study, compared to 50% in the systemic treatment arm, and 0% in the untreated control arm. Dose response was also demonstrated for OncoPLEX in these studies. Systemic toxicity was lower following the local application of OncoPLEX versus systemic docetaxel. Additional data in a pharmacokinetic model showed that the maximal plasma concentration of docetaxel was greater than10 times lower with OncoPLEX than with systemic docetaxel. Based on these compelling preclinical results, PolyPid intends to conduct additional preclinical safety studies of OncoPLEX in various type of solid tumor resections, in order to complete a preclinical package for the filing of pre-Investigational New Drug meeting request with the U.S. Food and Drug Administration in 2021 and potentially initiate a Phase 1 clinical trial in 2022. | ||||
PolyPid announced that… PolyPid announced that the first patient has been enrolled and randomized in the SHIELD II trial, the Company's second of two Phase 3 clinical trials for its lead product candidate, D-PLEX, for the prevention of post-abdominal surgery incisional infection. SHIELD II is a prospective, multinational, multicenter, randomized, double-blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX administered concomitantly with the Standard of Care, compared to a SoC-treated control arm, for the prevention of post-abdominal surgery incisional infection. The primary endpoint of the trial is the infection rate, as measured by the proportion of subjects with at least one abdominal target incisional infection event within 30 days post-abdominal surgery, determined by a blinded independent adjudication committee. The trial will enroll a minimum of 900 patients, with a maximum of approximately 1,400 subjects, as defined by the adaptive study design, in approximately 60 centers in the United States, Europe and Israel. |
Over a month ago | ||||
Key Opinion Leaders Drs.… Key Opinion Leaders Drs. Schaff, Senagore and Zmora discuss the burden and challenges related to surgical site infections (SSIs) post-cardiovascular and colorectal surgeries, while management discusses the development and commercial plans for D-PLEX100 on a conference call to be held on December 15 at 8 am. Webcast Link | ||||
Key Opinion Leaders Drs.… Key Opinion Leaders Drs. Schaff, Senagore and Zmora discuss the burden and challenges related to surgical site infections (SSIs) post-cardiovascular and colorectal surgeries, while management discuss the development and commercial plans for D-PLEX100 on a conference call to be held on December 15 at 8 am. Webcast Link | ||||
Key Opinion Leaders Drs.… Key Opinion Leaders Drs. Schaff, Senagore and Zmora discuss the burden and challenges related to surgical site infections (SSIs) post-cardiovascular and colorectal surgeries, while management discuss the development and commercial plans for D-PLEX100 on a conference call to be held on December 15 at 8 am. Webcast Link |
Key Opinion Leaders Drs.… Key Opinion Leaders Drs. Schaff, Senagore and Zmora discuss the burden and challenges related to surgical site infections (SSIs) post-cardiovascular and colorectal surgeries, while management discusses the development and commercial plans for D-PLEX100 on a conference call to be held on December 15 at 8 am. Webcast Link | |
Key Opinion Leaders Drs.… Key Opinion Leaders Drs. Schaff, Senagore and Zmora discuss the burden and challenges related to surgical site infections (SSIs) post-cardiovascular and colorectal surgeries, while management discuss the development and commercial plans for D-PLEX100 on a conference call to be held on December 15 at 8 am. Webcast Link | |
Key Opinion Leaders Drs.… Key Opinion Leaders Drs. Schaff, Senagore and Zmora discuss the burden and challenges related to surgical site infections (SSIs) post-cardiovascular and colorectal surgeries, while management discusses the development and commercial plans for D-PLEX100 on a conference call to be held on December 15 at 8 am. Webcast Link | |
PolyPid announced that it… PolyPid announced that it will host a key opinion leader call on D-PLEX100 for the prevention of surgical site infections on Tuesday, December 15, 2020, at 8:00 am Eastern Time. The call will feature presentations by KOLs Hartzell V. Schaff, MD, Mayo Clinic, Anthony J. Senagore, MD, Formerly of UTMB at Galveston, and Oded Zmora, MD, Shamir Medical Center, Israel, who will discuss the burden and challenges related to surgical site infections post colorectal and cardiovascular surgeries and the opportunity for D-PLEX100 to change the current status quo for the better. Dr. Schaff, Dr. Senagore, and Dr. Zmora will be available to answer questions following the formal presentations. PolyPid's management team will also discuss its developmental plans for D-PLEX100. | |
As previously reported,… As previously reported, Raymond James analyst Elliot Wilbur upgraded PolyPid to Strong Buy from Outperform with an unchanged price target of $23. With the shares down 40% since the company's June IPO despite regulatory "wins" in the form of FDA Fast-Track and Breakthrough Therapy Designations, he sees an "increasingly positive reward-to-risk framework," Wilbur tells investors. The BTD for DPLEX for the prevention of surgical site infections in patients undergoing elective colorectal surgery provides additional benefits in terms of increased FDA interaction and potentially shorter FDA review times, according to Wilbur. |