Trial Background Information:
The RNS trial was performed under 2 distinct stages. In stage 1 of the trial which is the safety and tolerable phase where patients get admitted into the hospital for 48 hours. Patients are prescribed a NanaBis starting from low to high dose followed by frequent blood test. This test is performed on patients who are diagnosed with cancer and manageable pain. In order to proceed with the stage 2 of the clinical trial it is very necessary that stage 1 is successfully completed. In Stage 2 is a phase where treatment is done on patients diagnosed with advanced cancer and suffering from intractable pain. In this phase there is a dose escalation on advanced cancer patients. The dosage escalation model is based on patients showing tolerance followed by continuing safety profiles. During this stage those patients will be closely monitored who are dependent on opioids.
As per the recent update Medlab Clinical Ltd (ASX: MDC) has successfully completed Stage 1 clinical trial of NANABIS at Royal North Shore Hospital (RNS). In order to proceed with the clinical trial of stage 2, MEDLAB has now got approval from Data Safety Monitoring Board (DSMB). Their main focus will be on safety followed by dosage escalation and tolerance as well. Stage 1 of the clinical trial showed results that helped in pain reduction.
Australian medical life sciences company, Medlab Clinical Ltd (ASX: MDC) is happy to announce about the successful completion of stage 1 and has received a formal approval from the DSMB to proceed with the stage 2 of the clinical trial of the human cancer. At this stage the company expresses its gratitude to DSMB members for their time and support.
After the successful completion of Stage 1, Medlab is pleased to share some key data findings. NanaBis is safe to use. It is effective up to 9 hours after the single dose. Within 30 minutes NanaBis levels detected after first blood draw. Early indications confirmed that NanaBis is proved helpful in pain reduction.
The Director of Medical Research, at Medlab Prof Luis Vitetta finds the results of the clinical trial to be very effective based on the data which was received. The CEO of Medlab Dr. Sean Hall stated that the results confirmed are based on the original hypothesis which were validated, and it offered a true alternative to current pain medications. He is also optimistic about the data from the stage 2 trial.
The overall performance of the company is 80.15%. However, the one-year performance of the company is -48.15%. For the year ended 30 June 2018, the company made a net loss of A$4,758,201. The total asset of the company is A$24,326,972 and the total liabilities A$2,468,409. This indicates that company is in position to clear its long-term obligations. The total current asset of the company is A$23,814,746 and total current liabilities is A$2,349,791. This indicates that company is in a position to meet its short-term obligations. The total shareholders equity is worth A$21,858,563. The cash used in operating activities is A$4,775,366 where the major cash outflow was due to the payments made to the suppliers and the employees. The company purchased plant and equipment as a result of which the net cash outflow from the investing activities is A$96,477. The net cash inflow from the financing activities is worth A$23,677,982. The cash and cash equivalent at the end of the financial year was A$20,332,694.
The current market price of the share is A$0.36 (AEST: 1:35 pm) with market capitalization of 72.81 million.
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