BioCancell reports results of BC-819 Phase I/IIa clinical trial for pancreatic cancer

Tikcro Technologies Ltd. (OTC BB: TIKRF) today announced that BioCancell reported results from a Phase I/IIa clinical trial to establish the safety, optimal dose and preliminary efficacy of BioCancell's lead drug-candidate, BC-819, as a treatment for pancreatic cancer. The trial demonstrated a significant decrease in local pancreatic tumors and no appearance of metastatic disease in most patients treated with the higher of two dosages tested after one month and three months.

Moreover, BC-819 demonstrated an excellent safety profile with no severe side effects, and no patient complaints about pain or discomfort, connected to the use of BC-819 during the trial.

This Phase I/IIa clinical trial included nine patients with non-resectable (inoperable) pancreatic cancer and with no metastases. Medical centers included the University of Maryland Medical Center, MD, in the USA and Hadassah, Sheba, Meir and Hillel Yafe medical centers in Israel. Each patient received four doses of BC-819, twice per week for two weeks. Three patients received the lower dose (4 mg), and six patients received the higher dose (8 mg).

In total, 5 out of 8 patients (62.5%) tested after 3 months showed significant tumor reduction or stability, together with no appearance of metastases. The higher dosage given in the trial showed greater efficacy than the lower dosage given. In this sub group that received the higher dosage:

• Three out of five (60%) patients treated with the higher dosage had the local pancreatic tumor shrink over 30% in tumor length with no appearance of metastases, meeting the industry commonly used criteria for Partial Response;
• The remaining two patients of the five met the criteria for Stable Disease, of no significant change in the size of the pancreatic tumor and no appearance of metastases;
• Two of the patients in the higher dosage group became resectable after treatment:
  • One patient underwent a successful operation to remove the tumor.
  • The second patient showed reduction of half of the tumor length; however, the discovery of liver metastases increased the overall risks for a procedure.

This trial was based on treatment with BC-819 only. However, results of pre-clinical testing performed by Biocancell using BC-819 in conjunction with Gemzar, an approved first line treatment drug, has shown that the volume of tumors shrank significantly in comparison to animals treated with Gemzar alone. Moreover, there was no appearance of metastases in the animals treated with the sequential administration of BC-819 and Gemzar, while majority of animals treated with Gemzar alone showed metastatic growth.

BioCancell intends to apply to the US Food and Drug Administration (FDA) to commence a Phase IIb clinical trial of BC-819 in sequence with Gemzar for the treatment of the disease. Biocancell has been granted "orphan drug" status from the US FDA for use of BC-819 in pancreatic cancer.

Tikcro holds approximately 30% of Biocancell, taking into account the conversion of a convertible note and exercise of warrants, and approximately 22% on a fully diluted basis. Shares of Biocancell are traded on the Tel Aviv Stock Exchange (TASE). The valuation of the holding in Biocancell is influenced, among other factors, by the share price of Biocancell on TASE.