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Clinical efficacy

Avemar was used exclusively as a form of supportive therapy, i.e. as a supplement to active oncotherapy.

Colorectal cancer
Following radical surgery, supportive administration of Avemar delays the development of distant metastases, particularly in the liver. In clinical stage I-IV patients who had undergone radical surgery, Avemar significantly increased both the overall and progression-free survival rate.

Head and neck cancerrs
Patients suffering from tumours of the larynx, pharynx and salivary glands showed improvement in their quality of life parameters (relief in cachectic symptoms, increase in body weight). In five salivary gland tumour patients, long-term inhibition of progression was observed.

Cancer of the oral cavity
An open, prospective and controlled study was conducted on 43 patients treated 'lege artis': 22 were treated with Avemar + lege artis, while 21 were allocated to the lege artis group (i.e., chemotherapy and/or radiotherapy). In clinical stage II, III and localized stage IV patients who continued with Avemar during a 12 month follow-up period, the combination of Avemar with lege artis therapy resulted in a significant decrease of progression-related events (local recurrence, distant metastases, death).

Malignant melanoma of the skin
In stage III patients, the combination of Avemar with Dacarbazin therapy produced a significant decrease in progression-related events, including the development of new visceral and lymph node metastases. The time which lapsed before the formation of distant metastases and the progression-free survival time significantly increased.

Other effects:
1. Febrile neutropenia: Children with solid tumours undergoing intensive chemotherapy were treated with Avemar (11 control (i.e., standard therapy) patients and 11 Avemar + standard therapy patients, with allocation on a matched pair basis). The frequency of febrile neutropenia occurrences, as compared to the number of chemotherapy cycles, decreased significantly in the group receiving Avemar.
Quality of life A) In breast cancer patients, a 3 year long treatment with Avemar resulted in a significant improvement of the physical, emotional and global health status of the patient. Improvement was observed in the following symptoms: nausea/vomiting, insomnia, hair loss.
B) Advanced lung cancer. Avemar used for 8±2 months as a supplement to standard oncotherapy resulted in an improvement in global health status and a significant decrease in fatigue.

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The product and its registration status
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The Approved Avemar label
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