Clinical Trials Activity Update for February 2024

Clinical trials are integral to providing optimal patient care, enhancing medical understanding, and developing new therapeutics as well as improving existing ones. From raising the standard of care for various diseases to laying the foundation of revolutionary medical devices, clinical trials significantly impact the healthcare landscape. As medical challenges turn more complex, clinical trials become increasingly important in addressing the unmet medical needs of a growing patient population, particularly those with chronic and new infectious diseases.

Let’s explore some significant clinical trial activities of February 2024, poised to transform the healthcare landscape by treating unmet needs of patients.

Launch of PIVOT-006 Trial Offers New Hope for Non-Muscle-Invasive Bladder Cancer (NMIBC) Patients

In February 2024, CG Oncology Inc, a United States-based biotechnology company, announced the launch of the phase 3 PIVOT-006 trial (NCT06111235) to evaluate the efficacy of a novel therapy cretostimogene grenadenorepvec (CG0070) in the management of intermediate-risk non-muscle-invasive bladder cancer (NMIBC), following transurethral resection of the bladder tumor (TURBT). This innovative oncolytic immunotherapy might offer a promising treatment option for those with frequent disease recurrence and repetitive surgery. The trial plans to enrol 426 patients across the United States and Canada, with overall recurrence-free survival (RFS) as the primary endpoint. The secondary endpoints of the study are recurrence-free survival at 12 and 24 months, progression-free survival, and the incidence of adverse events. Besides the PIVOT-006 trial, which is expected to reach primary completion in 2028, cretostimogene is involved in other investigative studies focused on different NMIBC populations and combination studies.

According to the data published by the American Cancer Society, it is estimated that around 83,190 new cases of bladder cancer cases will emerge in 2024. Further, it is reported that bladder cancer will be the cause of 16,840 deaths. The rising global burden of this disease is expected to directly impact its treatment market. According to EMR calculations, the bladder cancer treatment market size is anticipated to grow at a CAGR of 9.31% during the forecast period of 2024-2032, likely to reach a market value of USD 8.98 billion by 2032.

Expansion of Greenwich LifeSciences’ Flamingo-01 Phase III Trial for Breast Cancer Treatment

On February 14, 2024, Greenwich Lifesciences, Inc., a clinical-stage biopharmaceutical company in the United States, announced the expansion of its Phase III clinical trial, Flamingo-01, which aims to evaluate the efficacy and safety profile of GLSI-100 in HER2/neu positive breast cancer patients. GLSI-100 is a cancer peptide vaccine with a combination of GP2 and GM-CSF, expected to carry therapeutic potential in preventing breast cancer recurrences. Led by Baylor College of Medicine (a medical school and research center in Houston, Texas), the randomized study has around 750 participants and is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival.

The approval to expand Flamingo-01 in the five European countries including Spain, France, Germany, Italy, and Poland, it enables the activation of 105 sites post-completion of site contracts as well as site initiation visits scheduled as early as March 4, 2024. Moreover, this expansion will allow the trial to recruit up to 150 global sites to advance breast cancer treatment.

India Achieves Major Milestone with Human Clinical Trial of Gene Therapy for Haemophilia A

India made history in the field of medical science by conducting a pioneering human clinical trial of gene therapy for haemophilia A (deficiency in factor VIII or FVIII clotting activity). In this study, a lentiviral vector was utilized to express an FVIII transgene in the patient's haematopoietic stem cells. The trial was held at Christian Medical College (CMC) in Vellore in a collaborative initiative with the Department of Biotechnology, the Centre for Stem Cell Research (a unit of InStem Bengaluru), and Emory University in the United States along with the Christian Medical College.

Patients with haemophilia A are more susceptible to bleeding or experience prolonged bleeding after injury or surgery as they lack a protein required for blood to clot called FVIII. According to the EMR report, the haemophilia A market is likely to attain a value of USD 49.60 billion by 2032 and is anticipated to grow at a CAGR of 22.8% during the forecast period of 2024-2032. There is a growing demand for innovative therapeutic approaches such as gene therapies to treat this life-threatening condition, which is expected to augment gene therapy market growth in the coming years.

Biocomposites Launches Two New Phase II Clinical Trials of STIMULAN VG to Treat Diabetic Foot Osteomyelitis

Biocomposites Ltd, a medical device company headquartered in the United Kingdom, announced the launch of two-Phase II clinical trials of STIMULAN VG (STIMULAN mixed with vancomycin and gentamicin) in the United States. In the BLADE-VG2 trial, the safety and efficacy of STIMULAN VG will be tested to treat diabetic foot osteomyelitis whereas the BLADE-OPU2 trial will evaluate STIMULAN VG’s safety profile and effectiveness in the treatment of stage IV pressure ulcers.

The trials are part of an investigational new drug (IND) application and intend to show the STIMULAN VG’s potential to improve patient outcomes, reduce the incidence of recurrent infection, and minimize the use of antibiotics. The BLADE-VG2 trial has started to recruit patients and the BLADE-OPU2 trial is expected to start shortly. With the growing number of foot osteomyelitis and stage IV pressure ulcer patients, there is an urgent need to investigate the efficacy of such promising treatments that can help in infection management cases and reduce systemic antibiotic use.

Novel CAR T-Cell Therapy Shows Promise in Targeting Ovarian Tumors

In February 2024, Anixa Biosciences, Inc. announced that the first-in-human Phase I study to investigate the efficacy of a novel CAR T-cell therapy in ovarian cancer patients has started with its second cohort of patients. Conducted through a research partnership with the H. Lee Moffitt Cancer Center and Research Institute, the trial is reported to have an estimated enrolment of 48 patients. The data in the first 3 patients receiving follicle-stimulating hormone receptor (FSHR T)-mediated T cell treatment exhibited positive results leading to the second cohort of patients where the therapy will be examined at triple the dose given in cohort 1.

In this trial, the researchers are directly administering the engineered T cells into the peritoneum, a site for most ovarian tumor lesions to prevent any adverse events. The FSHR-mediated CAR T technology or chimeric endocrine receptor T-cell (CER-T) therapy offers an innovative approach to treat ovarian cancer and other FSHR-expressing tumours by targeting hormone receptors. Although the study is in its initial phase, this CAR T-cell therapy is expected to offer a novel treatment option for patients with ovarian cancer.

Clinical trials act as a robust research tool to advance medical knowledge and improve patient outcomes. Not only do they measure the efficacy of new therapeutics, but they also help healthcare providers weigh the side effects of a treatment against its potential benefits, thereby assisting them in making the best possible treatment plan for the patient. Moreover, with the rise in technological advancements and research endeavours aimed at developing highly efficient therapeutics, the demand and diversity of clinical trials are likely to grow in the near future.