Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Iscador*P · 1 trial · 1 indication
To estimate the event free survival for pediatric, adolescent and young adult patients with relapsed resectable osteosarcoma who are receiving treatment with subcutaneous Iscador® P following complete resection of all disease.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm - Iscador*P | EXPERIMENTAL | Each Iscador® P therapy begins with a dose finding phase related to the drug' immunogenicity. In this phase, gradually increasing doses are used to determine the optimum individual dose response of the patient and to prevent excessive toxicity. The Iscador® P will be administered three times per week by subcutaneous injections (M,W,F) into the subcutaneous tissue of the thigh or abdomen. Treatment is administered according to a series of escalating doses that are given each of the three days in a week for 7 doses. There are 3 different series (Series 0, 1, and 2) and there are 7 dose vials in each series. Once the patient has reached their maximum tolerated dosing series, that series is used as the treatment regimen for the remaining weeks to a total duration of 52 weeks (13 cycles) or until disease progression. Each cycle is 4 weeks. |
| Name | Type | Description |
|---|---|---|
| Iscador*P | DRUG | Iscador P given for 2 cycles with follow up imaging done every 2 cycles. If imaging is negative patient remains on study for 13 cycles. If new lesion is found, then patient is off study. |
Inclusion Criteria: * Histologic diagnosis of osteosarcoma. * Patients with at least one episode of relapse in the lung (without limitation of number of episodes), following surgical resection of all gross metastatic disease. * Surgical resection of all possible sites of suspected pulmonary metasta...
Iscador*P is an investigational small molecule being studied for the treatment of recurrent resectable osteogenic sarcoma. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated in a clinical trial for this specific oncology indication.
The molecular target of Iscador*P has not been disclosed in available information. The drug is classified as a small molecule immunotherapy and is being investigated for its potential role in treating recurrent osteogenic sarcoma, but its specific mechanism of action is not publicly detailed.
Iscador*P is being developed by Meridian Bioscience Inc, a company traded under the ticker symbol VIVO. The company is conducting clinical research on this investigational drug for the treatment of recurrent osteogenic sarcoma.
Iscador*P is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is actively recruiting participants to evaluate the drug's safety and efficacy in patients with recurrent resectable osteogenic sarcoma.
Iscador*P is being studied in a single Phase 2 clinical trial with the identifier NCT05726383. This trial, titled 'Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma,' is currently recruiting participants in the United States and aims to enroll 32 patients.
Yes, Iscador*P is the same as Iscador P. The asterisk in the drug name is a stylistic variation, and the clinical trial refers to it as 'Iscador® P (Mistletoe).' Both names refer to the same investigational drug being developed for recurrent osteogenic sarcoma.