Hoth Therapeutics Announces Positive Data from First-of-its-Kind Human Patient Treatment of EGFRI-Associated Skin Toxicities with HT-001
Hoth Therapeutics (NASDAQ: HOTH) has announced positive data from a first-of-its-kind human patient treatment using HT-001 for epidermal growth factor receptor inhibitor (EGFRI) associated papulopustular eruptions (PPEs). The patient, a 59-year-old female with metastatic breast cancer, experienced significant symptom improvement after just one week of treatment, allowing her to discontinue HT-001 after only seven days. This rapid success highlights HT-001's potential as an effective therapy for EGFRI-associated skin toxicities, which affect up to 90% of cancer patients undergoing EGFRI therapy. A Phase 2a clinical trial is currently underway to further evaluate HT-001's efficacy and safety, with multiple prestigious cancer centers participating in the study.
Hoth Therapeutics (NASDAQ: HOTH) ha annunciato dati positivi da un trattamento su pazienti umani, il primo del suo genere, utilizzando HT-001 per le eruzioni papulopustolari associate agli inibitori del recettore del fattore di crescita epidermico (EGFRI). La paziente, una donna di 59 anni con carcinoma mammario metastatico, ha mostrato un miglioramento significativo dei sintomi dopo solo una settimana di trattamento, permettendole di interrompere HT-001 dopo soli sette giorni. Questo rapido successo evidenzia il potenziale di HT-001 come terapia efficace per le tossicità cutanee associate agli EGFRI, che colpiscono fino al 90% dei pazienti con cancro in trattamento con EGFRI. Un trial clinico di Fase 2a è attualmente in corso per valutare ulteriormente l'efficacia e la sicurezza di HT-001, con la partecipazione di diversi prestigiosi centri oncologici allo studio.
Hoth Therapeutics (NASDAQ: HOTH) ha anunciado datos positivos de un tratamiento en pacientes humanos, el primero de su tipo, utilizando HT-001 para las erupciones papulopustulares asociadas a los inhibidores del receptor del factor de crecimiento epidérmico (EGFRI). La paciente, una mujer de 59 años con cáncer de mama metastásico, experimentó una mejora significativa de los síntomas después de solo una semana de tratamiento, lo que le permitió interrumpir HT-001 después de solo siete días. Este rápido éxito destaca el potencial de HT-001 como una terapia eficaz para las toxicidades cutáneas asociadas a EGFRI, que afectan hasta al 90% de los pacientes con cáncer en tratamiento con EGFRI. Actualmente se está llevando a cabo un ensayo clínico de Fase 2a para evaluar más a fondo la eficacia y seguridad de HT-001, con múltiples centros oncológicos prestigiosos participando en el estudio.
Hoth Therapeutics (NASDAQ: HOTH)가 최초의 인간 환자 치료에서 HT-001을 사용하여 상피세포 성장 인자 수용체 억제제(EGFRI)와 관련된 구진농포성 발진(PPEs)에 대한 긍정적인 데이터를 발표했습니다. 메타스타틱 유방암 환자인 59세 여성은 단 일주일의 치료 후 증상이 크게 개선되어 단 7일 후 HT-001을 중단할 수 있었습니다. 이 빠른 성공은 EGFRI 치료를 받는 암 환자의 최대 90%에 영향을 미치는 EGFRI 관련 피부 독성에 대한 효과적인 치료제로서 HT-001의 가능성을 강조합니다. 현재 HT-001의 효능과 안전성을 추가로 평가하기 위해 여러 유명 암 센터가 참여하는 2a상 임상 시험이 진행 중입니다.
Hoth Therapeutics (NASDAQ: HOTH) a annoncé des données positives d'un traitement sur des patients humains, le premier de ce genre, utilisant HT-001 pour les éruptions papulopustulaires associées aux inhibiteurs du récepteur du facteur de croissance épidermique (EGFRI). La patiente, une femme de 59 ans atteinte d'un cancer du sein métastatique, a connu une amélioration significative de ses symptômes après seulement une semaine de traitement, lui permettant d'arrêter HT-001 après seulement sept jours. Ce succès rapide met en avant le potentiel de HT-001 en tant que thérapie efficace pour les toxicités cutanées associées aux EGFRI, qui touchent jusqu'à 90 % des patients atteints de cancer sous thérapie EGFRI. Un essai clinique de Phase 2a est actuellement en cours pour évaluer plus avant l'efficacité et la sécurité de HT-001, avec la participation de plusieurs centres oncologiques prestigieux à l'étude.
Hoth Therapeutics (NASDAQ: HOTH) hat positive Daten aus einer ersten Behandlung von menschlichen Patienten mit HT-001 für papulopustuläre Eruptionen (PPEs), die mit dem Inhibitor des epidermalen Wachstumsfaktorrezeptors (EGFRI) verbunden sind, bekannt gegeben. Die Patientin, eine 59-jährige Frau mit metastasiertem Brustkrebs, hat bereits nach einer Woche Behandlung eine signifikante Verbesserung der Symptome erfahren, sodass sie HT-001 nach nur sieben Tagen absetzen konnte. Dieser schnelle Erfolg hebt das Potenzial von HT-001 als effektive Therapie für EGFRI-assoziierte Hauttoxizitäten hervor, die bis zu 90 % der Krebspatienten betreffen, die eine EGFRI-Therapie erhalten. Derzeit läuft ein Phase 2a-Klinikversuch, um die Wirksamkeit und Sicherheit von HT-001 weiter zu bewerten, an dem mehrere angesehene Krebszentren teilnehmen.
- Rapid symptom improvement in patient after just one week of HT-001 treatment
- Patient able to discontinue treatment after only seven days due to swift resolution of lesions
- No new lesions developed in the three weeks following treatment
- HT-001 shows potential as an effective therapy for EGFRI-associated skin toxicities
- Phase 2a clinical trial underway with participation from prestigious cancer centers
- None.
Insights
This is a significant development in managing EGFRI-associated skin toxicities. The rapid resolution of symptoms within just one week is remarkable, as these side effects typically persist throughout EGFRI treatment. This could be a game-changer for cancer patients, potentially improving treatment adherence and quality of life.
However, it's important to note that this is a single case study. While promising, we need more extensive clinical data to confirm efficacy across a broader patient population. The ongoing Phase 2a trial will be critical in validating these results. If consistent, HT-001 could become a standard of care for managing EGFRI-induced skin toxicities, addressing a major unmet need in cancer supportive care.
Hoth Therapeutics' HT-001 shows promise in a lucrative niche market. With EGFRIs widely used in cancer treatment and skin toxicities affecting up to
However, investors should note that Hoth is still in early clinical stages. The path to FDA approval and commercialization is long and costly. The company's ability to fund ongoing research and potential partnerships with larger pharmaceutical companies will be crucial. While this news is positive, it's important to consider Hoth's overall pipeline and financial position when evaluating its long-term prospects.
The rapid efficacy demonstrated in this case is intriguing, but we must approach these results with cautious optimism. Single-patient outcomes, while encouraging, are not statistically significant. The ongoing Phase 2a trial across multiple prestigious cancer centers will provide more robust data on HT-001's efficacy and safety profile.
Key aspects to watch in future trial results include:
- Consistency of response across a larger patient cohort
- Duration of effect after treatment cessation
- Any potential interactions with EGFRI efficacy
- Safety profile in extended use
Cancer Patient Ceased Treatment After One Week Due to Rapid Success
In the reported case, the patient, a 59-year-old female undergoing treatment at George Washington University for metastatic breast cancer, experienced significant improvement in symptoms just one week after initiating HT-001 therapy. Due to the swift resolution of lesions and the alleviation of discomfort, the patient was able to discontinue the treatment after just seven days. Over the following three weeks, no new lesions developed, further highlighting the potential of HT-001 as an effective and safe therapy for EGFRI-associated PPEs.
EGFRIs are widely used to treat various cancers of epithelial origin but are frequently associated with cutaneous side effects, most notably PPEs like acneiform rash, which can occur in up to
In the reported case, the patient, a 59-year-old female undergoing treatment at George Washington University for metastatic breast cancer, experienced significant improvement in symptoms just one week after initiating HT-001 therapy. Due to the swift resolution of lesions and the alleviation of discomfort, the patient was able to discontinue the treatment after just seven days. Over the following three weeks, no new lesions developed, further highlighting the potential of HT-001 as an effective and safe therapy for EGFRI-associated PPEs.
"We are thrilled with the positive data from this first investigator led study patient case," said Robb Knie, CEO of Hoth Therapeutics. "HT-001 has the potential to significantly improve the quality of life for cancer patients suffering from EGFRI-induced skin toxicities. This rapid and successful treatment is an important milestone as we continue to explore HT-001's potential to meet this critical unmet need."
A Phase 2a clinical trial is currently underway to further evaluate the efficacy and safety of HT-001 in the management of EGFRI-associated skin toxicities. Current sites include MD Anderson Cancer Center, University of
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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