Hoth Therapeutics Announces Plans to Submit Expanded Access Application for HT-001 to Support Cancer Patients in Need
Hoth Therapeutics (NASDAQ: HOTH) has announced plans to submit an Expanded Access application for its therapeutic candidate HT-001. The drug is being developed to treat dermatological side effects in cancer patients using EGFR inhibitor treatments.
The company aims to make HT-001 available through the Expanded Access Program (EAP), also known as 'compassionate use', which allows patients with serious conditions to access investigational treatments outside traditional clinical trials. This initiative comes following positive progress in ongoing clinical studies.
The EAP submission represents a strategic move to provide treatment access while gathering additional safety and efficacy data for HT-001, specifically targeting patients who lack comparable treatment options.
Hoth Therapeutics (NASDAQ: HOTH) ha annunciato piani per presentare una domanda di Accesso Espanso per il suo candidato terapeutico HT-001. Il farmaco è in fase di sviluppo per trattare gli effetti collaterali dermatologici nei pazienti oncologici che ricevono trattamenti con inibitori dell'EGFR.
L'azienda mira a rendere disponibile HT-001 attraverso il Programma di Accesso Espanso (EAP), noto anche come 'uso compassionevole', che consente ai pazienti con condizioni gravi di accedere a trattamenti sperimentali al di fuori delle tradizionali sperimentazioni cliniche. Questa iniziativa arriva dopo progressi positivi negli studi clinici in corso.
La presentazione dell'EAP rappresenta una mossa strategica per fornire accesso al trattamento raccogliendo al contempo ulteriori dati sulla sicurezza e sull'efficacia di HT-001, specificamente rivolgendosi a pazienti che non hanno opzioni di trattamento comparabili.
Hoth Therapeutics (NASDAQ: HOTH) ha anunciado planes para presentar una solicitud de Acceso Expandido para su candidato terapéutico HT-001. El medicamento se está desarrollando para tratar los efectos secundarios dermatológicos en pacientes con cáncer que reciben tratamientos con inhibidores de EGFR.
La empresa tiene como objetivo hacer que HT-001 esté disponible a través del Programa de Acceso Expandido (EAP), también conocido como 'uso compasivo', que permite a los pacientes con condiciones graves acceder a tratamientos en investigación fuera de los ensayos clínicos tradicionales. Esta iniciativa llega tras un progreso positivo en los estudios clínicos en curso.
La presentación del EAP representa un movimiento estratégico para proporcionar acceso al tratamiento mientras se recopilan datos adicionales sobre la seguridad y la eficacia de HT-001, dirigido específicamente a pacientes que carecen de opciones de tratamiento comparables.
Hoth Therapeutics (NASDAQ: HOTH)는 치료 후보물질 HT-001에 대한 확대 접근 신청서를 제출할 계획을 발표했습니다. 이 약물은 EGFR 억제제 치료를 받는 암 환자들의 피부 관련 부작용을 치료하기 위해 개발되고 있습니다.
회사는 확대 접근 프로그램(EAP)을 통해 HT-001을 제공할 계획이며, 이는 '동정적 사용'이라고도 알려져 있으며, 중증 질환을 앓고 있는 환자들이 전통적인 임상 시험 외부에서 실험적 치료에 접근할 수 있도록 허용합니다. 이 이니셔티브는 현재 진행 중인 임상 연구에서 긍정적인 진전을 이룬 후에 나오게 되었습니다.
EAP 제출은 치료 접근을 제공하는 동시에 HT-001의 추가 안전성과 유효성 데이터를 수집하기 위한 전략적 조치를 나타내며, 특히 비교 가능한 치료 옵션이 없는 환자들을 대상으로 하고 있습니다.
Hoth Therapeutics (NASDAQ: HOTH) a annoncé des plans pour soumettre une demande d'Accès Élargi pour son candidat thérapeutique HT-001. Ce médicament est en cours de développement pour traiter les effets secondaires dermatologiques chez les patients atteints de cancer recevant des traitements par inhibiteurs de l'EGFR.
L'entreprise vise à rendre HT-001 disponible par le biais du Programme d'Accès Élargi (EAP), également connu sous le nom d' 'usage compassionnel', qui permet aux patients atteints de maladies graves d'accéder à des traitements expérimentaux en dehors des essais cliniques traditionnels. Cette initiative fait suite à des progrès positifs dans les études cliniques en cours.
La soumission de l'EAP représente un mouvement stratégique pour fournir un accès au traitement tout en recueillant des données supplémentaires sur la sécurité et l'efficacité de HT-001, en ciblant spécifiquement les patients qui n'ont pas d'options de traitement comparables.
Hoth Therapeutics (NASDAQ: HOTH) hat Pläne angekündigt, einen Antrag auf erweiterten Zugang für seinen therapeutischen Kandidaten HT-001 einzureichen. Das Medikament wird entwickelt, um dermatologische Nebenwirkungen bei Krebspatienten zu behandeln, die EGFR-Inhibitoren erhalten.
Das Unternehmen zielt darauf ab, HT-001 über das Erweiterte Zugangsprogramm (EAP) verfügbar zu machen, das auch als 'mitfühlende Nutzung' bekannt ist und es Patienten mit schweren Erkrankungen ermöglicht, Zugang zu experimentellen Behandlungen außerhalb traditioneller klinischer Studien zu erhalten. Diese Initiative folgt auf positive Fortschritte in den laufenden klinischen Studien.
Die Einreichung des EAP stellt einen strategischen Schritt dar, um den Zugang zu Behandlungen zu ermöglichen, während gleichzeitig zusätzliche Sicherheits- und Wirksamkeitsdaten für HT-001 gesammelt werden, insbesondere für Patienten, die über vergleichbare Behandlungsoptionen nicht verfügen.
- Expansion of HT-001 accessibility through EAP indicates positive clinical trial progress
- Additional data collection opportunity through EAP to support drug development
- Addressing unmet medical need in cancer treatment side effects
- Drug still in clinical-stage, not yet FDA approved
- EAP program may increase operational costs
Insights
Hoth Therapeutics' application for Expanded Access (compassionate use) for HT-001 represents a strategic progression in their clinical development program. This topical treatment addresses a significant supportive care gap for cancer patients on EGFR inhibitors, who frequently experience debilitating rash, dry skin, and inflammation that can lead to therapy dose reductions or discontinuations.
The FDA typically grants expanded access only when there's preliminary evidence of safety and potential efficacy, suggesting Hoth's ongoing clinical studies may be yielding encouraging safety signals. However, this doesn't replace the need for completing the full clinical trial process.
The timing is notable as it suggests the company believes their safety profile is robust enough to support wider patient access while formal studies continue. For patients currently suffering from EGFR inhibitor-induced dermatologic toxicity with treatment options, this could provide a meaningful alternative.
While this represents progress in Hoth's development timeline, investors should recognize that expanded access programs primarily serve humanitarian purposes rather than commercial ones. The program may provide additional supportive safety data, but expanded access is not a revenue-generating activity and doesn't guarantee eventual approval.
HT-001 is being developed to alleviate the adverse dermatological effects experienced by cancer patients undergoing epidermal growth factor receptor (EGFR) inhibitor treatments. With positive progress in ongoing clinical studies, Hoth Therapeutics aims to provide patients access to HT-001 outside of traditional clinical trials through the Expanded Access Program (EAP), commonly known as "compassionate use."
HT-001 is being developed to alleviate the adverse dermatological effects experienced by cancer patients undergoing epidermal growth factor receptor (EGFR) inhibitor treatments. With positive progress in ongoing clinical studies, Hoth Therapeutics aims to provide patients access to HT-001 outside of traditional clinical trials through the Expanded Access Program (EAP), commonly known as "compassionate use."
"Submitting an Expanded Access application is an important step in our commitment to ensuring patients who may benefit from HT-001 have the opportunity to receive this promising treatment," said Robb Knie, CEO of Hoth Therapeutics. "We remain dedicated to advancing solutions that address critical unmet medical needs and improve quality of life for patients undergoing cancer treatment."
The Expanded Access Program is designed to provide investigational treatments to patients with serious or life-threatening conditions who lack comparable treatment options. Through this program, Hoth Therapeutics seeks to offer HT-001 to eligible patients while continuing to gather valuable data on its safety and efficacy.
For more information about HT-001, ongoing clinical trials, or the Expanded Access Program, please visit www.hoththerapeutics.com
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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FAQ
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