trial announcement

Solbec have just annuonced the first patient has completed the first cycle of treatment . Note they are doing phase 1 and 2 trials .
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Human Clinical Trials – First Patient Enrolled
Summary:
• Solbec enrolls its first patient in its phase I/IIA clinical trial of its lead compound SBP002.
• It is anticipated that the results will support the results seen in it Special Access patients.
• The trial is designed to provide clear dosage safety guidelines and to observe responses under
strictly controlled conditions.
The first patient to be enrolled in human clinical trials for Solbec Pharmaceuticals LTD’s anti-cancer
drug SBP002 at Sir Charles Gardiner Hospital in Perth has completed their first cycle of treatment.
The Phase I/IIA trial which began two weeks ago, is to evaluate safety, tolerability and
pharmacokinetics in Solbec’s lead cancer drug, SBP002, in patients with advanced solid tumours. It is
expected that a maximum of 25 patients will be enrolled into the trial.
Professor Michael Millward, an experienced and well-respected clinical trials researcher, and his team
are conducting the Phase I/IIA trials at Sir Charles Gardiner Hospital a recognised oncology centre of
excellence.
In separate animal studies, SBP002 has shown reduced tumour growth rates, which resulted in the
eradication of melanoma and mesothelioma in mice.
Use of SBP002 in our Special Access patients has provided Solbec with a wealth of anecdotal clinical
evidence on the potential of the drug. However, the clinical trials will enable us to establish clear
dosage safety guidelines and to observe responses under strictly controlled conditions. We anticipate
positive results from patients involved in the trial. Based on the results, further clinical trials may be
done, focusing on difficult to treat cancers like melanoma and mesothelioma.
Solbec intend to use the results of the trial to complete an Investigational New Drug application (IND)
for the United State Food and Drug Administration (FDA) to permit a clinical trial program in the US.
Solbec Managing Director, Stephen Carter said “that unlike trials for many other drug treatments
which can take several years, trials for SBP002 can expect to be completed within a much shorter
time frame. SBP002 is being developed for the Orphan Drug Program which does not require the
extensive Phase III studies normally required in drug development.”
“The protracted nature of bringing a drug to market is one of the greatest hurdles for biotechnology
technology companies. Not so with SBP002 – a major attraction for Solbec investors, and even better
news for cancer sufferers.” Mr. Carter said.