Shares of Adventrx Pharmaceuticals Inc. (ANX) have gained more than 48 percent in the last three months and trade around $3. With the company's cancer drug candidate heading closer to the FDA decision date, there has been a renewed interest in the stock.
The drug candidate under regulatory review is Exelbine, or ANX-530, for the proposed treatment of non-small-cell lung cancer. Exelbine is a novel emulsion formulation of vinorelbine, which is marketed as Navelbine, a chemotherapy drug usually given to treat breast cancer and non-small-cell lung cancer.
In the U.S., Navelbine is approved to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin. In the European Union, Navelbine is approved to treat non-small cell lung cancer and advanced or metastatic breast cancer. Generic equivalents of Navelbine have been available in the U.S. since February 2003.
The NDA for Exelbine was initially submitted to the FDA in December 2009. Much to the disappointment of the company, the regulatory agency issued a refusal-to-file letter for that NDA, indicating a CMC (chemistry, manufacturing and controls) reason.
The company resubmitted the Exelbine NDA in November 2010, including twelve months of site-specific stability data from its intended commercial manufacturer. The NDA, which was accepted for filing by the FDA in January of this year was assigned a decision date of September 1, 2011.
The NDA for Exelbine is a 505(b)(2) application. The 505(b)(2) regulatory pathway allows a company to rely, at least in part, on the FDA's findings of safety and/or effectiveness for a previously approved drug (the "reference drug"). Adventrx's 505(b)(2) NDA submission included data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of Exelbine and Navelbine, the reference drug.
According to Adventrx, Navelbine and its generic equivalents are often associated with injection site reactions, including phlebitis, erythema and pain at the site of injection. Exelbine, while being bioequivalent to Navelbine, is designed to reduce the incidence and severity of injection site reactions.
The company's yet another late-stage product candidate is ANX-514, a novel, detergent-free reformulation of docetaxel, a chemotherapy drug, sold under the brand name Taxotere.
Docetaxel, which is indicated for the treatment of a number of cancers including breast, non-small cell lung, prostate, gastric, and head and neck cancers, went off patent in the U.S. in November 2010. The drug logged in sales of approximately $1.2 billion in the U.S. last year. The first generic formulation of Taxotere was approved by the FDA in March of this year.
Adventrx's ANX-514 is designed to reduce the incidence and severity of hypersensitivity reactions and also minimize other adverse reactions that are associated with Taxotere. For ANX-514 too, the company intends to seek approval under the 505(b)(2) regulatory pathway. Adventrx has been asked by the FDA to conduct an additional clinical study that could support approval of ANX-514, and the company is developing a study protocol for submission to the regulatory agency.
The company added a novel, rheologic and antithrombotic compound to its pipeline following the acquisition of SynthRx Inc., a private biotechnology company in February, 2011. The drug candidate poloxamer 188, now known as ANX-188, has already been evaluated by SynthRx in multiple clinical studies, including a 255-patient, randomized, double-blind, placebo-controlled phase III study in patients with sickle cell disease in acute vaso-occlusive crisis. ANX-188 has an orphan drug status for the treatment of sickle cell crisis.
Sickle cell disease is an inherited blood disorder. The hemoglobin molecules in the blood of sickle cell disease patients stick to one another, forming rigid rods within the red blood cells, stopping the flow of blood. This leads to depletion of oxygen from tissues in other parts of the body causing a number of maladies, including kidney failure, diseases of the retina, strokes, pneumonia and severe pain. Signs and symptoms of sickle cell disease usually begin in early childhood. It is estimated that over 100,000 people in the Unites States and 2 million people globally are affected by sickle cell disease.
Droxia (hydroxyurea), developed by Bristol-Myers Squibb Co. (BMS), is the only FDA-approved drug for sickle cell disease. It was approved in 1998 for that indication.
Adventrx has plans to meet with the FDA to reach an agreement on a phase III clinical trial protocol for ANX-188 for the treatment of pediatric patients with sickle cell disease in acute crisis.
A quick look at Adventrx's balance sheet...
The company has not generated any revenue from product sales to date and has a history of annual losses from operations since its inception in 1996. As of March 31, 2011, the company had an accumulated deficit of $159 million and no debt.
The upcoming FDA decision on September 1 and the large market opportunity that exists for ANX-188, a drug candidate for sickle cell disease, are reasons to keep an eye on Adventrx.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.