Biodexa Pharmaceutical’s (NASDAQ: BDRX) shares have shown substantial volatility during today’s trading session, experiencing gains of nearly 150% at various points. Biodexa specializes in the development of treatments for brain cancer. More importantly, the company recently completed the enrollment and treatment phase for nine children participating in a study involving their lead asset, MTX110.

Allow us to provide a simplified explanation of the announcement, to enhance your understanding of the company’s efforts to improve clinical outcomes for primary and metastatic brain cancers.
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About MTX110 Clinical Trial:
In this particular study, the enrolled children, aged between 4 and 17 years, underwent radiation therapy as per standard medical practice. After that, they had surgery to implant a special catheter and a programmable pump directly into their tumors. The purpose of this implant is to deliver a drug called MTX110 into the tumor site. Out of the nine patients, eight have received two infusions of MTX110 via a technique called convection-enhanced delivery (CED), with different concentrations of the drug being tested.
The important update is that there have been no reports of serious side effects or toxicities related to the use of MTX110 in this study. The drug has been well-tolerated by the patients.
The study aims to evaluate the safety and effectiveness of MTX110 in treating children with DMGs, which is a highly challenging and life-threatening disease. The survival rate for patients with DMGs is very low, and current treatment options are limited. The results of this study are expected to be made public in early 2024, providing valuable information about the drug’s impact on the disease.
Insights from Retail Investors:
As previously mentioned, Microcap stocks often have a limited number of available shares, commonly referred to as a “tight” or “low” float. In the case of $BDRX, they recently underwent a reverse stock split because their stock price fell below the minimum bid compliance standard on NASDAQ. This reverse split was significant, with a ratio of one-for-eighty (1-80), and was effective on July 5th, 2023. Consequently, the number of shares available for trading decreased substantially, leading to a significant increase in trading volatility. It’s worth noting that $BDRX has one of the lowest floats we’ve observed on NASDAQ, with only 220.22k shares available for trading. Many Retail investors would consider this a “Nano-float”. Given the circumstances, it’s understandable that stocks like this can experience highly significant price fluctuations, attracting a large number of investors seeking quick gains through short-term trading strategies.
About Diffuse Midline Gliomas (DMGs):
DMGs is a type of brain tumor that occurs in the middle part of the brain. It cannot be surgically removed and mostly affects children. The average survival rate is around 9 to 11 months, and most patients die within a year of diagnosis. The current treatments, such as chemotherapy, are not very effective because the drugs have difficulty reaching the brain. About 1,100 people worldwide are diagnosed with DMG each year.
About MTX110:
MTX110 is a modified form of a drug called panobinostat. It is designed to be delivered directly to the tumor site through a catheter system, bypassing the blood-brain barrier. This allows for high concentrations of the drug to be delivered to the tumor while minimizing side effects. MTX110 is being studied for its effectiveness in treating recurrent glioblastoma, pediatric DMG, and recurrent medulloblastoma. Previous studies have shown promising results in laboratory tests using DMG and glioblastoma cells.
About Phase 1 Clinical Trials:
The primary goal of a Phase 1 clinical trial is to assess the safety and tolerability of a new drug or treatment in a small group of participants. Phase 1 trials are the earliest stage of human testing and usually involve a relatively small number of healthy volunteers or patients. The main objectives of Phase 1 trials are:
Safety: Phase 1 trials aim to identify any potential side effects or adverse reactions associated with the treatment. Researchers closely monitor participants for any negative effects and determine the dose levels that can be tolerated.
Dosage determination: These trials help determine the appropriate dosage range for further studies. Researchers may administer different doses to participants to evaluate the drug’s pharmacokinetics (how the drug is absorbed, distributed, metabolized, and eliminated by the body) and determine the optimal dose for further investigation.
Pharmacokinetics and pharmacodynamics: Phase 1 trials assess how the drug is processed in the body, including its absorption, distribution, metabolism, and elimination. They also evaluate how the drug interacts with the body’s cells and affects the targeted disease or condition.
Preliminary efficacy: Although Phase 1 trials primarily focus on safety, they may also provide initial data on the treatment’s effectiveness. Researchers may evaluate early signs of efficacy or measure biomarkers to determine if the drug is having the desired effects.
Overall, the main goal of a Phase 1 clinical trial is to gather essential information about the drug’s safety profile, establish an appropriate dosage range, and lay the groundwork for further studies in subsequent phases (Phase 2 and Phase 3) to evaluate the treatment’s efficacy and potential benefits.
Conclusion:
Biodexa Ltd (NASDAQ: BDRX) has achieved another significant milestone with its lead asset, MTX110. The limited number of available shares following their stock split has resulted in rapid stock movement, attracting investors seeking quick profits from potential substantial gains. According to their presentation deck, there are several important upcoming milestones and catalysts to monitor in the coming months. These include the release of Phase 1 ‘203 study data in DMG, submission of Phase 2 IND in DMG, the publication of MAGIC-G1 study cohort A PFS data, and the initiation of the Phase 2 study in DMG.
We will update you on BDRX when more details emerge, subscribe to Microcapdaily to follow along!
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