Tag: clinical trial

selectION, Inc. Advances Lead Program for Treatment of T Cell Mediated Autoimmune Diseases to Clinical Development

– Novel ion channel blocker designed to combine high efficacy and durable response while maintaining full immune system functionality

San Diego, CA, USA, and Munich, Germany – May 9, 2022 – selectION, Inc., a biopharmaceutical company developing novel peptide therapies for the treatment of T cell mediated autoimmune diseases and rare lymphomas, today announced that Germany´s regulatory agency has authorized the Company’s clinical trial application for a Phase 1b trial evaluating the safety and efficacy of selectION´s clinical candidate, si-544, in patients diagnosed with mild to severe atopic dermatitis.

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Company News: ISA Pharmaceuticals Initiates Phase I/II Clinical Trial of ISA101 in Patients with Anal Intraepithelial Neoplasia (AIN)

Therapeutic vaccine against Human Papilloma Virus type 16 (HPV16) tested in HIV-positive male patients

ISA Pharmaceuticals B.V., a clinical-stage biopharmaceutical company focusing on rationally designed, fully synthetic therapeutic vaccines against cancer and persistent viral infections, today announced the initiation of a Phase I/II clinical study of its lead candidate ISA101 in HIV-positive men suffering from anal intraepithelial neoplasia (AIN). The study is supported by ZonMw, the Dutch Organisation for Health Research and Development, and is being conducted in The Netherlands.

ISA101 is a synthetic long peptide (SLP®) vaccine for the treatment of diseases induced by human papilloma virus type 16 (HPV16), such as cervical cancer, ano-genital premalignant and malignant lesions, and head and neck cancer.

The open-label, dose-response study will be conducted in 30 HIV-positive male patients suffering from HPV16-positive high-grade AIN, who failed previous treatment. In the first dose escalation part of the trial, patients will be vaccinated with ISA101 in three dosing cohorts three times at three-week intervals, either with or without administration of peg-interferon-α on the day of vaccination. An additional group of 15 patients will be treated with the optimal ISA101 schedule. Primary clinical endpoints will be toxicity and safety as well as regression of lesions at 3, 6 and 12 months. Secondary endpoints are regression of lesions at 18 months and HPV16-specific immunity in the blood.

AIN is caused by infection with high-risk papilloma viruses (HPV) and known as a cancer precursor lesion that can lead to the development of anal cancer. AIN of any grade has been reported to be present in 63–81% of HIV-positive men, and high-grade disease (AIN 2 or 3) in 25–52%. The majority (approximately 60%) of high-grade AIN is caused by HPV16. Incidence of anal cancer has increased significantly since 1997 in both men and women, and especially in HIV-positive men. This is assumed to be a result of the significantly prolonged life span of HIV-positive patients. Therefore, early diagnosis and treatment of AIN is important to prevent malignancy. At present, there is no systemic treatment.

Company News: Nanobiotix Starts Clinical Trial with Lead Product NBTXR3

– A Completely New Cancer Treatment to Be Tested in Patients with Soft Tissue Sarcoma –

Nanobiotix, a company developing novel cancer nanotherapeutics, announced today that its lead compound NBTXR3 has received the formal authorization from the French Medicine Agency, AFSSAPS[1], to start the first clinical trial[2].

27 patients diagnosed with soft tissue sarcoma will be enrolled in the Phase I study and will receive NBTXR3 as an intra-tumoral injection with radiotherapy prior to surgery (first-line treatment) (www.clinicaltrial.gov). The primary endpoints of the clinical trial are the feasibility of NBTXR3 administration and safety. Preliminary data are expected by the end of 2012.

The trial is a prospective, open-label, dose-escalation, single arm, non-randomized trial. NBTXR3 will be administered to the patients prior to surgery by a single intra-tumoral injection followed by standard radiotherapy procedure. After completion of the regular treatment procedure, the patients will undergo surgery to resect the soft tissue sarcoma. Along with the safety and feasibility endpoints, the primary tumor tissue will then be available for the evaluation of the pathological response rate.

Further clinical trials are in preparation in Europe and in the US. NBTXR3 has been classified in the EU as class III medical device. In the US, it has been classified as a drug by the FDA.

NBTXR3, the most advanced compound of Nanobiotix´ NanoXray pipeline, is intended to enhance the local destruction of the tumor mass during radiotherapy. NBTXR3 is a nanoparticle consisting of hafnium oxide crystals. Once injected into the tumor, NBTXR3 accumulates in the cancer cells. Due to the physical properties of hafnium oxide, the particles emit huge amounts of electrons upon radiation. This leads to the formation of radicals within the tumor cell, which in turn damage the cancer cells and cause their targeted destruction. NBTXR3 particles are inert and emit electrons only during their exposure to radiotherapy. As a result, the destructive power of standard radiation therapy could be locally and selectively enhanced within the tumor cells.

Local treatment of malignant tumors is a cornerstone of cancer therapy. The standard treatments are surgery and radiotherapy, either as a stand-alone treatment or in combination. Radiotherapy has been widely used across most oncology indications for decades. About 50 to 60% of all cancer patients undergo radiotherapy treatment as part of existing treatment guidelines. All NanoXray products are compatible with these guidelines and do not require changes of surgery and radiotherapy procedures. Moreover, NanoXray products can be used with any existing standard radiation equipment available in almost every hospital world-wide.


[1] Agence Française de Sécurité Sanitaire des Produits de Santé

[2] Clinical trial, registration number RCB 2011-A00342-39