Biodexa reports promising glioblastoma trial results

CARDIFF, UK - Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a biopharmaceutical firm focused on developing treatments for diseases with unmet medical needs, announced encouraging interim results from its MAGIC-1 study involving MTX110 for recurrent glioblastoma (rGBM). The ongoing Phase 1 trial has shown that patients treated with MTX110 have experienced progression-free survival (PFS) and overall survival (OS) rates that surpass historical averages for this aggressive form of adult brain cancer.

The MAGIC-1 study (NCT05324501) aims to assess the safety, feasibility, and efficacy of MTX110 in treating rGBM. So far, patients #1 and #2 in Cohort A have achieved OS of 12 and 13 months, respectively. Patient #3 has reached 13 months of OS with six months of PFS, while Patient #4 has seen 12 months of both PFS and OS without progression.

These outcomes are notable given that median survival following rGBM recurrence is typically around 6.5 months. MTX110 employs a convection-enhanced delivery (CED) system, which uses a surgically implanted catheter and pump to directly administer the drug to the tumor, potentially increasing its effectiveness and reducing side effects by avoiding the blood-brain barrier.

MTX110 also shows promise in treating Diffuse Midline Glioma (DMG), a pediatric and universally fatal brain cancer. Early trial results have indicated a median OS of 26.1 months in a UCSF Phase 1 study and 16 months in a Columbia University trial, both of which are improvements over the historical median survival of 10 months.

The data from these trials suggest that MTX110 could potentially offer a new standard of care for patients with rGBM and DMG. The glioblastoma treatment market, valued at $2.5 billion in 2022, is projected to grow annually by nearly 10% through 2030.

Biodexa's strategic development of MTX110 positions it as a potential breakthrough in the treatment of aggressive brain cancers. The continuation of Phase 1 trials will be crucial in determining whether MTX110 can advance to later-stage clinical trials. These developments are based on a press release statement from Biodexa Pharmaceuticals.

In other recent news, Biodexa Pharmaceuticals has been making significant strides in its clinical development programs. The company recently secured an extension to meet Nasdaq's minimum bid price requirement, ensuring its continued listing until October 31, 2024. Additionally, Biodexa reported encouraging survival rates in its Phase 1 study of MTX110 for the treatment of recurrent glioblastoma.

The company has also adjusted its American Depositary Receipts (ADRs) ratio to comply with Nasdaq's minimum bid price requirement. Further, Biodexa has unlocked the remaining funds from a $17 million grant awarded by the Cancer Prevention and Research Institute of Texas to support the Phase 3 study of its drug eRapa for Familial Adenomatous Polyposis.

In other financial developments, Biodexa secured a $5.0 million registered direct offering and concurrent private placement with Ladenburg Thalmann & Co. Inc. as the sole placement agent. These funds are intended to support Biodexa's development programs, including the Phase 3 clinical trial for eRapa.

On the clinical front, Biodexa reported positive results from a Phase 2 trial for eRapa, marking a significant reduction in polyp burden among Familial Adenomatous Polyposis patients. These recent developments highlight Biodexa's continued efforts to address diseases with unmet medical needs.

InvestingPro Insights

Biodexa Pharmaceuticals' promising interim results for its MTX110 treatment come at a critical time for the company. According to InvestingPro data, Biodexa's market capitalization stands at a modest $4.88 million, reflecting the early-stage nature of its drug development efforts.

Despite the positive clinical outcomes, InvestingPro Tips highlight some financial challenges. The company is "quickly burning through cash," which is not uncommon for biotech firms in the research and development phase. This cash burn rate is particularly significant given that analysts anticipate a sales decline in the current year, with net income expected to drop as well.

On a positive note, Biodexa "holds more cash than debt on its balance sheet," which could provide some financial flexibility as it continues its clinical trials. This is crucial as the company is currently "not profitable over the last twelve months," according to another InvestingPro Tip.

The stock has seen a "significant return over the last week," with a 69.7% price increase. However, this should be viewed in the context of longer-term performance, as the stock price "has fallen significantly over the last year" by 91.92%.

For investors interested in a deeper analysis, InvestingPro offers 15 additional tips for Biodexa Pharmaceuticals, providing a more comprehensive view of the company's financial health and market position.

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