More details of Phase 2 trial of TH-302 expected soon(NASDAQ:THLD)

Hypoxia Activated Prodrug (also called HAP in short) is a type of anti cancer drug that is used by patients suffering from Tumor Hypoxia. This is condition where there is a lack of oxygen in the tumor cells. Hypoxia Activated Prodrug drugs treat levels of hypoxia (that is, low levels of oxygen) found in tumor cells but not in normal cells. Threshold Pharmaceuticals Inc. (NASDAQ:THLD) is one of the three companies that are developing Hypoxia Activated Prodrug to treat tumor hypoxia and its symptoms (such as frequent relapse). The drug it is developing has a proposed name of TH-302. The results of the clinical trials of TH-302 had been presented at the 28^th Annual J.P. Morgan Healthcare Conference. The healthcare conference was held from January 10 to January 14, 2010 in San Francisco. The company also announced that it would disclose whether pancreatic cancer or relapsing non small cell lung cancer would be targeted by the Phase 2 clinical trial. The disclosure is expected to be made on January 31, 2010.

@@AdsenseLeft@@ The 1/2 clinical trials of Th-302 consist of 3 phases: namely, 401 trial, 402 trial and 403 trial. In 401 trial, TH-302 is used as monotherapy to treat patients who have advanced solid tumors. TH-302 is used for patients with advanced solid tumor in 402 trial too; however, TH-301 is not used alone but together with gemcitabine, docetaxel or pemetrexed. Finally, in 403 trial, TH-302 is used together with doxorubicin for treating patients suffering from advanced soft tissue sarcoma. Already 200 patients suffering from cancer have been given TH-302.

120 patients participated in the 402 trial, which dealt with “dose escalation” and “dose expansion”. As a whole, the level of hematologic toxicity in the second phase – that is, 402 trial – was greater that of chemotherapy. Much hematologic toxicity had occurred when TH-302 was used in combination with other drugs for chemotherapy. The toxicities of the skin and mucus were also common. TH-302 was mainly used at a dose between 340 and 400 mg/m2. However, when TH-302 was used in standard chemotherapies, it did not increase the toxicities of other body organs further.

@@CalendarRight@@ Barry Selick, Ph.D., who is the Chief Executive Officer of Threshold Pharmaceuticals Inc., said,

“We are extremely pleased with the activity of TH-302, especially when combined with full dose chemotherapy. Within the next few weeks we will be finalizing which cancer indication will be the target of our first controlled Phase 2 trial of TH-302, which we expect will be either front-line pancreatic cancer or relapsed/refractory non-small cell lung cancer. We believe that the Phase 1/2 results are sufficiently promising for each of these indications to warrant continued development in either one alone, or both.”

In the 403 trial, 36 patients with soft tissue sarcoma participated. TH-302 showed an extremely high level of tolerance. Plus, there were no grave unforeseen accidents affecting the patients’ safety. The participants mainly suffered from nausea. Toxicities of the skin and the mucus were also frequent.

In the 401 trial, 126 patients participated. This trial found the maximum tolerated dose level and the dose-limiting toxicities associated with using TH-302 in patients suffering from advanced solid tumors. The trial also found the effectiveness and the safety of TH-302.