Genta commences new tesetaxel Phase 2 clinical trial in advanced bladder cancer

Genta Incorporated (OTCBB: GETA.OB) today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced bladder cancer. Tesetaxel is the leading oral taxane in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY, the Kimmel Cancer Center at Jefferson University, Philadelphia, PA, and at least one site in the EU.

“Standard taxanes are active in bladder cancer, but as yet none has received regulatory approval”

The new study will examine the efficacy and safety of tesetaxel in patients with advanced bladder cancer who have developed progressive disease after treatment with a single 1^st-line regimen. The 1^st-line regimen is expected to be a combination of cisplatin plus gemcitabine (Gemzar^®; Eli Lilly, Inc.). The primary endpoint of this study is overall response rate. Secondary endpoints include durable response, disease control, progression-free survival, and safety. The dose for the new trial was determined from Genta's ongoing studies in patients with advanced gastric cancer and advanced melanoma.

Patients who progress on 1^st-line treatment for invasive bladder cancer have a poor prognosis, and toxicity is an important issue in clinical care. Compared with standard taxanes, clinical and preclinical data show that tesetaxel:

• Eliminates serious (occasional fatal) hypersensitivity reactions
• Eliminates requirements for premedication (e.g., steroids, antihistamines, etc.)
• Reduces damage to peripheral nerves
• Is not cross-resistant with standard taxanes
• Offers flexible and convenient dosing for patients

"Standard taxanes are active in bladder cancer, but as yet none has received regulatory approval", said Dr. Raymond P. Warrell, Jr., Genta's Chairman and Chief Executive Officer. "Recently, two large companies terminated their programs with potentially competitive agents in this indication. Thus, an important unmet need has opened for a highly active agent that may reduce side effects. Having observed preliminary activity in Phase 1, we wish to swiftly clarify the potential activity of tesetaxel in this disease that, if confirmed, could lead to registration-directed clinical trials."