Hoth Therapeutics Expands Clinical Trial for Cancer Patients
Hoth Therapeutics (NASDAQ: HOTH) has expanded its First-in-Human Phase 2a clinical trial for HT-001, a treatment for skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients. The company received approval from three prestigious medical centers: GW University Hospital, UC Irvine, and Northwell Health.
The trial aims to investigate the efficacy, safety, and tolerability of topical HT-001. CEO Robb Knie expressed optimism that the trial will demonstrate successful delivery of their lead therapeutic candidate and provide hope for cancer patients suffering from EGFRi-related skin toxicities. More information about this dose-ranging study is available on clinicaltrials.gov.
- Expansion of Phase 2a clinical trial for HT-001 with three new prestigious medical centers
- Potential to address skin toxicities associated with EGFRi treatments in cancer patients
- None.
Insights
Hoth Therapeutics' announcement of expanding their clinical trial with three new sites—GW University Hospital, UC Irvine and Northwell Health—signals a significant step forward in their ongoing research into HT-001 for treating skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi). EGFR inhibitors are commonly used in treating various cancers, but they often lead to challenging skin side effects that can impact patients' quality of life and adherence to treatment.
The inclusion of these prestigious institutions could enhance the credibility and robustness of the trial results, which in turn might expedite the regulatory process if the data is compelling. For a retail investor, this is noteworthy because increased clinical trial sites often lead to larger sample sizes and more reliable data, which are important for regulatory approval and subsequent commercialization.
However, it's essential to understand that Phase 2a trials primarily focus on assessing efficacy, safety and dosage. They are not definitive proof of a drug's success. Results from this phase will determine whether the drug can move to later stages of clinical trials. If successful, this could position Hoth Therapeutics as a key player in the dermatology sector of oncology treatments.
The expansion of the clinical trial to additional sites marks a strategic move for Hoth Therapeutics. Collaborating with prominent institutions like GW University Hospital, UC Irvine and Northwell Health not only boosts the trial's profile but also potentially broadens its data diversity and reliability. From a market perspective, the implementation of Phase 2a trials is a critical milestone. It reflects the company's progression and commitment to addressing the needs of cancer patients undergoing EGFRi treatments.
In terms of market impact, investors should consider that positive Phase 2a results might attract partnerships or acquisition interests from larger pharmaceutical companies looking to expand their oncology pipelines. Moreover, if HT-001 proves to be effective, it could tap into a substantial niche market, considering the widespread use of EGFR inhibitors in cancer treatment. However, the market remains highly competitive and any delays or failures in later stages could negatively impact the stock.
Understanding the potential market size and current competition is key for investors. This trial expansion increases the likelihood of achieving more reliable and comprehensive data, which is essential for future phases and eventual market entry.
Three New Sites Join HT-001 Trial, GW University Hospital, UC Irvine and Northwell Health
"We are very pleased to have received approval from these three world class medical centers for our FIH clinical trial," said Hoth Therapeutics Chief Executive Officer, Robb Knie. "We are hopeful that this trial will demonstrate successful delivery of our lead therapeutic candidate HT-001 and bring hope to cancer patients suffering from skin toxicities associated with EGFRi treatments."
This Phase 2a dose- ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi. More information can be found at clinicaltrials.gov.
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/ .
Forward-Looking Statement
This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.
Investor Contact:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
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SOURCE Hoth Therapeutics, Inc.
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