<Think Equity recently stated that it sees ANX having a strong potential catalyst in the second half of 2007.>
By Fain Hughes, fhughes@knobias.com
The FDA has granted fast track designation for ADVENTRX Pharmaceuticals, Inc.'s (ANX) ANX-510, or CoFactor(R) injection. CoFactor(R) is currently being investigated in a pivotal Phase 3 study, with 5-fluorouracil (5-FU) and bevacizumab, for the initial treatment of metastatic colorectal cancer. CoFactor(R) is a folate-based biomodulator drug designed to enhance the activity and reduce associated toxicity of the widely used cancer chemotherapeutic agent 5-FU. The primary endpoint for the study is progression-free survival. Secondary endpoints include response rate, overall survival and incidence and severity of adverse events.
Genentech Inc.'s (DNA) AVASTIN(R)(bevacizumab), in combination with intravenous 5-FU-based chemotherapy, is currently indicated for first- or second-line treatment in patients with metastatic carcinoma of the colon or rectum. 5-FU is one of the oldest chemotherapy drugs and has been in use for decades. 5-FU is most commonly used in treatment of colon, breast, stomach and pancreas cancers. The life span of 5-FU in blood and body tissues is very short and limited to minutes in cancer cells. Therefore, enhancements are required to prolong the life span of 5-FU within the cancer cells. Some patients experience severe side effects from even the smallest doses of 5-FU. These adverse events include anemia, diarrhea, stomach pain, low white blood cell counts, low platelet counts, skin sensitivity to sun exposure and soreness of the mouth which results in difficulty swallowing. Treatment with Avastin can result in the development of Gastrointestinal (GI) perforation and wound healing complications.
Leucovorin is an enhancement that is widely used in synergistic combination with 5-FU. CoFactor has been designed to replace leucovorin as the preferred method to enhance the activity and reduce associated toxicity. CoFactor creates more stable binding of the active form of 5-FU to the target enzyme. It also bypasses the metabolic pathway required by leucovorin to deliver the active form of folate, allowing 5-FU to work more effectively. CoFactor is also in a Phase 2 clinical trial for the treatment of advanced breast cancer.
The Company recently finalized a Clinical Trial Cooperative Research and Development Agreement (CRADA) under which U.S. Department of Veterans Affairs (VA) clinical sites may participate in the Company's Phase 3 clinical trial of ANX-510 (CoFactor) for the treatment of metastatic colorectal cancer. To date, under this arrangement, the Company has executed clinical trial agreements with three regional VA centers.
ADVENTRX is also focused on the commercialization of proprietary product candidates for the treatment of other cancers and infectious diseases. Cancer treatments in development include ANX-530 for treatment of non-small cell lung and other cancers; ANX-513, a novel formulation of paclitaxel, an agent for treatment of breast, ovarian and non-small cell lung cancers; ANX-514, a novel formulation of docetaxel, an agent for treatment of breast, non-small cell lung, prostate and gastric cancers; and Organoselenones, agents for treatment of drug-resistant cancers. Infectious disease programs include ANX-201, a pyrophosphate analog and novel reverse transcriptase inhibitor for HIV; ANX-015, a formulation of the macrolide antibiotic, clarithromycin; and ANX-016, a novel formulation of the parenteral glycopeptide antibiotic, vancomycin.
For the second quarter ended June 30, 2007, the Company narrowed losses to $5.72 million, or 6 cents a share, from a year-earlier loss of $15.2 million, or 21 cents a share. The Company had accumulated net losses of $88.4 million. Cash, cash equivalents, and short-term investments of approximately $43.7 million should be sufficient to sustain the Company's planned level of operations for at least the next twelve months. The Company is also in discussions with potential partners regarding certain of its product candidates.
Think Equity recently stated that it sees ANX having a strong potential catalyst in the second half of 2007. |
