What Is Pelareorep?
Pelareorep is an investigational drug currently being studied in clinical trials. It is a type of oncolytic virus, specifically a naturally occurring, non-pathogenic reovirus. This virus is designed to selectively infect and replicate within cancer cells, leading to their destruction while sparing healthy cells. This mechanism aims to stimulate an immune response against the tumor. Pelareorep is not currently approved by the U.S. Food and Drug Administration (FDA) for any condition. It is being investigated for its potential to treat various cancers, including different forms of breast cancer, colorectal cancer, recurrent plasma cell myeloma, and metastatic anal cancer. It is also being studied in a trial for anemia. A total of 10 clinical trials have been conducted or are ongoing for Pelareorep, involving 449 participants. The first trial began in 2010, and the latest is expected to conclude in 2026.Uses and Conditions Under Study
Pelareorep is primarily under investigation for its potential in treating various forms of cancer.- Breast Cancer: Pelareorep is being studied in 5 trials for different types of breast cancer, including Anatomic Stage IV Breast Cancer AJCC v8, Breast Cancer, Breast Cancer Metastatic, Locally Advanced Breast Carcinoma, and Metastatic Triple-Negative Breast Carcinoma. In these studies, Pelareorep is being explored for its ability to target and destroy cancer cells, potentially improving outcomes for patients with advanced or metastatic disease.
- Colorectal Cancer: There are 2 trials investigating Pelareorep for colorectal cancer, specifically mCRC (metastatic colorectal cancer) and MSS Metastatic Colorectal Cancer. The drug's oncolytic properties are being evaluated to see if it can effectively reduce tumor burden and enhance treatment responses in patients with this common gastrointestinal cancer.
- Recurrent Plasma Cell Myeloma: Pelareorep is being studied in 2 trials for recurrent plasma cell myeloma, a type of blood cancer. The aim is to determine if the reovirus can help eliminate myeloma cells, particularly in cases where the cancer has returned after previous treatments.
- Anal Cancer Metastatic: One trial is exploring Pelareorep for metastatic anal cancer. This study seeks to assess the drug's efficacy in patients whose anal cancer has spread to other parts of the body, offering a potential new therapeutic approach.
- Anemia: One trial is also investigating Pelareorep in patients with anemia. While the primary focus of Pelareorep is oncology, this trial may be exploring different aspects or potential side effects of the drug.
Dosing
Pelareorep is administered as an injectable solution, typically given intravenously (IV infusion) or subcutaneously (SC). The specific doses and schedules vary depending on the clinical trial and the condition being studied. Investigational doses have included Pelareorep at 1.5×1010 TCID50, 3×1010 TCID50, and 4.5×1010 TCID50. These doses are often given on specific days within a cycle, such as Day 1, 2, 8, 9, 15, and 16, sometimes in combination with other chemotherapy agents like Paclitaxel. For example, some studies have administered Pelareorep with Paclitaxel at 80 mg/m2 on Day 1, 8, and 15 of a 28-day cycle. The administration is typically via a 1-hour IV infusion. Different study arms and cohorts, such as Arm I (paclitaxel) and Arm II (paclitaxel and wild-type reovirus), have been used to evaluate the drug's effectiveness alone or in combination with standard therapies. Information regarding specific pediatric dosing is not available from the provided trial data, and all mentioned dosages appear to be for adult participants in investigational settings.Side Effects
Specific types and frequencies of individual side effects for Pelareorep are not detailed in the provided clinical trial data. However, overall counts of participants experiencing adverse events were reported in two studies.
In a study (NCT01199263) involving patients with recurrent or persistent ovarian, fallopian tube, or primary peritoneal cancer, the total number of reported instances of Grade 3 or higher adverse events across various categories was 89 in the paclitaxel-only group and 145 in the group receiving paclitaxel with Pelareorep.
Another study (NCT04215146) in patients with metastatic breast cancer reported the total number of patients who experienced adverse events and serious adverse events:
- 12 patients in the paclitaxel-only group.
- 16 patients in the group receiving paclitaxel with Pelareorep.
- 17 patients in the group receiving paclitaxel, Pelareorep, and avelumab.
Clinical Trial Results
Recurrent or Persistent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT01199263)
This study investigated Pelareorep in combination with paclitaxel compared to paclitaxel alone for patients with recurrent or persistent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
- Overall Survival (OS): The median overall survival was 13.1 months for patients treated with paclitaxel alone, compared to 12.6 months for patients receiving paclitaxel and Pelareorep.
- Progression-Free Survival (PFS): Patients treated with paclitaxel alone had a median progression-free survival of 3.94 months, while those receiving paclitaxel and Pelareorep had a median PFS of 4.39 months.
- Tumor Response by RECIST: The percentage of participants showing a tumor response according to RECIST criteria was 16.7% in the paclitaxel-only group and 13.0% in the paclitaxel and Pelareorep group.
Metastatic Breast Cancer (BRACELET-1 Study, NCT04215146)
The BRACELET-1 study assessed the overall response rate of Pelareorep in various combinations for patients with metastatic breast cancer.
- The overall response rate was 20% for patients receiving Pelareorep alone.
- When Pelareorep was combined with paclitaxel, the overall response rate increased to 31.3%.
- For patients receiving Pelareorep, paclitaxel, and avelumab, the overall response rate was 14.3%.
Currently Recruiting Trials
For patients interested in contributing to medical research, there are currently clinical trials actively recruiting participants to study Pelareorep. These studies aim to evaluate the safety and effectiveness of this investigational treatment in combination with other therapies for various advanced cancers.
One such study, identified as NCT07446322, is a Phase 2 trial focused on metastatic RAS-mutated, microsatellite-stable (MSS) colorectal cancer. This open-label, randomized, multicenter study is comparing the combination of FOLFIRI and bevacizumab with or without Pelareorep as a second-line treatment. It is designed for patients whose cancer has progressed after one prior oxaliplatin-based therapy. The trial is sponsored by Oncolytics Biotech and aims to enroll approximately 60 participants.
Another opportunity is presented by NCT07280377, a Phase 1/Phase 2 multiple-indication platform study. This trial explores treatment combinations involving Pelareorep and atezolizumab in patients with advanced or metastatic gastrointestinal cancers. Conditions under investigation include metastatic pancreatic cancer, metastatic colorectal cancer (both MSI-H/dMMR and 3L), and metastatic unresectable anal cancer. This study, also sponsored by Oncolytics Biotech, is designed to assess safety, identify potential immune-related biomarkers, and evaluate early efficacy, with an enrollment target of 122 participants across its various cohorts.
Where to Participate
Participation in clinical trials for Pelareorep is currently available at a limited number of sites. These research centers are located in specific geographic areas to facilitate patient enrollment and study conduct.
Currently, there are 2 sites across 2 cities in 2 states where you might be able to participate:
- Homewood, Alabama (1 site)
- Florham Park, New Jersey (1 site)
To be eligible for these studies, participants must generally be between the ages of 18 and 18 years. The trials are open to individuals of all genders. It is important to note that these studies are designed for patients with specific medical conditions, and healthy volunteers are not eligible to participate, nor are children.
Development Timeline
The journey of Pelareorep in clinical development began on September 10, 2010, with its first registered clinical trial. Initially, the research explored its potential in conditions such as IBS-C and hyperphosphatemia, demonstrating an early broad interest in its therapeutic applications. Over time, the focus significantly shifted towards oncology, driven primarily by Oncolytics Biotech, which has sponsored 4 trials, alongside contributions from the National Cancer Institute (NCI) and other institutions.
The development pipeline has steadily expanded, moving through various phases, including Early Phase 1, Phase 1, and Phase 1/Phase 2 studies, with 4 trials reaching Phase 2. This progression reflects a growing understanding of Pelareorep's potential. The range of conditions under investigation has broadened considerably from its initial indications to encompass a wide array of cancers. These now include Anatomic Stage IV Breast Cancer, Metastatic Triple-Negative Breast Carcinoma, Ras-mutated Metastatic Colorectal Cancer, Pancreatic Cancer Metastatic, and Squamous Cell Carcinoma of the Anus, among others.
To date, a total of 10 clinical trials have been conducted or are ongoing for Pelareorep, aiming to enroll a combined total of 449 participants. The latest projected completion date for a study is March 3, 2026, indicating ongoing research and commitment to understanding its full therapeutic potential in cancer treatment.