OTCBB: GETA - Genta Incorporated) LATEST NEWS!! Genta's Tesetaxel Granted Fast Track Designation by FDA for Advanced Gastric Cancer BERKELEY HEIGHTS, N.J., Apr 06, 2010 -- Genta Incorporated (OTCBB: GETA) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company's request for "Fast Track" designation of tesetaxel for treatment of patients with advanced gastric cancer. Tesetaxel -- a late Phase 2 oncology product -- is the leading oral taxane currently in clinical development.
Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The designation typically enables a Company to submit a New Drug Application (NDA) on a "rolling" basis with ongoing FDA review during the submission process. NDAs with Fast Track designation are also usually granted priority review by FDA at the time of submission.
Based on promising results in a Phase 2a trial, Genta is conducting a confirmatory Phase 2b trial of tesetaxel as 2nd-line treatment in patients with advanced gastric cancer who have failed a single 1st-line regimen. As defined, the 1st-line regimen must comprise a platinum-containing compound (cisplatin, carboplatin, or oxaliplatin) and a fluoropyrimidine (5-fluorouracil, capecitabine, or S-1). The Fast Track designation targets the patient population that is enrolling in the Phase 2b trial.
Genta has formulated a trial design and clinical protocol for a randomized, double-blind, placebo-controlled Phase 3 trial of tesetaxel in this patient population. In developing the trial, the Company completed a dose-ranging and pharmacokinetic study of tesetaxel plus capecitabine (Xeloda(R); Hoffmann LaRoche, Inc.). Results from that study showed that full doses of each of these orally administered drugs could be administered together without causing overlapping side-effects.
Genta plans to submit its proposed Phase 3 trial to FDA in the 2nd-quarter in order to secure a Special Protocol Assessment (SPA). The Company looks forward to meeting with the FDA to discuss the trial design.
About Tesetaxel Taxanes (including paclitaxel and docetaxel) are the most widely used chemotherapy drug class in cancer medicine. However, these agents are associated with serious safety issues, particularly hypersensitivity reactions related to intravenous infusions that are occasionally fatal and that require careful premedication and observation. Other prominent side-effects of this drug class include myelosuppression (low blood counts) and peripheral neuropathy (disabling nerve damage).
Tesetaxel is a novel taxane that is administered by mouth as a capsule. The drug was developed with a goal of maintaining the high antitumor activity while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience. The oral route also enables the development of novel schedules that may expand dosing options when tesetaxel is combined with other anticancer drugs (such as "all oral" chemotherapy programs). Tesetaxel has demonstrated high activity against cell lines that are resistant to paclitaxel and docetaxel.
As a late Phase 2 oncology product, tesetaxel has demonstrated anticancer activity in its initial clinical trials, and the drug has not been associated with the severe infusion reactions that are linked with conventional taxanes. Moreover, unlike other oral taxanes that have been developed, nerve damage has not been a prominent side effect of tesetaxel. Thus, the drug offers substantial opportunities to improve patient convenience, safety, and anticancer activity.
Tesetaxel in Advanced Gastric Cancer In the completed Phase 2a study, 35 patients with advanced gastric cancer were treated with tesetaxel at doses ranging from 27 to 35 mg/m(2) once every three weeks. All patients had received extensive prior treatment, having failed a combination regimen that included cisplatin plus 5-fluorouracil or capecitabine. All but 2 of these patients had also received a third chemotherapy drug along with this regimen. Final intent-to-treat analysis, including all patients enrolled in the study, showed that 5 patients achieved a partial response, 2 patients achieved a partial response unconfirmed by CT scan, and 14 patients achieved stable disease, for an overall major response rate of 20% and a disease-control rate of 60%. The most serious adverse reaction was Grade 3-4 neutropenia, which occurred in 57% of patients.
About Genta Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company's research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genasense(R) is being developed as an agent that may enhance the effectiveness of anticancer therapy. The Company is currently collecting long-term followup data on durable response and overall survival from the recently completed randomized Phase 3 study of Genasense(R) in patients with advanced melanoma (the AGENDA trial). The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Genta has initiated a broad clinical program to evaluate the safety and efficacy of tesetaxel in patients with solid tumors. In the U.S., Genta is exclusively marketing Ganite(R) (gallium nitrate injection), which is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite(R) that are being evaluated as potential treatments for diseases associated with accelerated bone loss. Ganite(R) and Genasense(R) are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at: www.genta.com.
-------------------------------------------------- (OTCBB: ARTS - Artfest International, Inc.) LATEST NEWS!! Artfest International, Inc. Signs Distribution Agreement With Second Largest Cable Operator in the Country Time Warner Cable to Distribute Artfest International's New Artfest Direct Program DALLAS, TX, Apr 06, 2010 -- Artfest International, Inc. (OTCBB: ARTS) is pleased to announce that Time Warner Cable will be the distribution outlet of Artfest International's "Artfest Direct" program to 550,000 Time Warner Cable customers. Artfest has an "On-Demand" distribution agreement with Time Warner, Inc., the second largest cable operator in the country, which will give Artfest International its base for the development of the Art Channel "On-Demand" program. Starting next month, Artfest will be showcasing its Art and Sports memorabilia, on its Time Warner Art Channel program slot. As part of the distribution agreement with Time Warner, Artfest is able to sell advertising/commercial space that is available on its Art Channel TV slot.
Time Warner Cable owns and manages cable systems connected to approximately 26 million homes in 33 states. The Company has 14.7 million customers for its video, high-speed data and residential telephone services. This includes 13.3 million basic video subscribers and more than 7 million customers who purchase at least two of the Company's primary services. Time Warner Cable operates some of the most technologically advanced and best-clustered cable systems in the country, with nearly 85 percent of the Company's customers located in five geographic regions: New York, Texas, Ohio, the Carolinas and southern California. It is the largest cable provider in the nation's two largest cities, Los Angeles and New York, and the second largest cable operator in the country.
"We are excited to launch our Art Channel on the second largest cable operator in the country," stated Edward Vakser, CEO of Artfest International, Inc. "After the successful launch of our Art Channel in Texas, we plan to expand our Art Channel nationwide by the end of 2010. We are pleased to have formed this relationship as we continue to increase our sales revenues and shareholder value." Artfest International recently filed its notification of late filling for the Company's 10-K with the SEC for period ending December 31, 2009. The notification was due to the growth the Company has experienced over the past year which included the acquisitions of Charity Sports Distributor as well as various events held at Artfest International's 52,000 square foot facility in Dallas, Texas, and direct sales activity through its Art Channel, Inc. and Art Channel Galleries, Inc. subsidiaries. The Company expects its 10-K to be filed within the next 10 days. |
