In the past two weeks, Adventrx Pharmaceuticals Inc. reported that it brought in $15 million to fund clinical trials, as well as saying it received clearance from the FDA to begin a Phase Ib/IIa trial of BlockAide/CR in HIV-1 positive patients.
In addition to BlockAide/CR, the San Diego-based company also has its lead cancer drug, CoFactor, which is in a Phase II trial.
Adventrx President and CEO Nicholas Virca told BioWorld Today that the company has raised about $35 million since its inception in October 2000.
"The outside analysis on [CoFactor] has been that what we have is highly, highly probable" to be efficacious, Virca said, adding that his approach is a "practical" one focused on getting a drug to market that is "low toxicity, will add value and will be part of almost any chemotherapy that is used in almost any cancer right now."
In the short term, the company is plotting a move to larger facilities in San Diego. Long term, it's focused on getting maximum value for its products, whether that is achieved through partnering or selling outright.
"I guess our biggest challenge will be whether or not we think we'll eventually want to partner this out," Virca said, adding that "every day we're dosing patients, and [with] every additional trial, the value is going up, as far as what we have to offer."
The company that was ultimately to be named Adventrx was born when a Los Angeles-based private company that Virca co-founded, Biokeys Pharmaceuticals Inc., was merged with the public company BioQuest Inc., founded in late 1996 in Houston.
Virca said, "We thought there were some synergies with the technologies and the people, and it was a vehicle for our private company to become public."
Adventrx executives also are working toward having the company traded on the American Stock Exchange in New York, Virca said. The company trades on the Over-the-Counter Bulletin Board now.
In this most recent fund raising, the company entered a definitive agreement for the sale to certain investors of about 10 million shares at $1.50 per share, as well as issuing to investors about 3 million five-year warrants to purchase shares of common stock at $2 per share and about 2 million five-year warrants to purchase common shares at $2.50 a share.
Adventrx describes itself as a company that "refines therapies through either replacement chemistry, using combinatorial synthesis methods, or through newer and more innovative biological approaches, such as those that trigger the immune system or prevent the infection phase of viruses." Its strategy thus far has been to in-license technology, and it has technology licensing agreements with the M.D. Anderson Cancer Center in Houston since June 1996, as well as the University of Southern California, which was entered by Biokeys in 1998.
Adventrx holds exclusive rights to three platform technologies for drug discovery, two new cancer drugs and an "improved class of broad-spectrum antivirals with antiviral and anticancer properties, and four new agents for HIV/AIDS therapy," the company said.
The latest $15 million secured will be used to fund the Phase II trial in colorectal cancer of CoFactor that began last quarter after Adventrx completed Phase I and II trials in Europe. CoFactor is a modulator for 5-fluorouracil (5-FU), a common cancer drug. CoFactor is designed to enhance the antitumor effects of 5-FU, while reducing side effects compared to current therapies. It is aimed at a market estimated at $450 million.
Virca said CoFactor is a form of folic acid that - unlike lucavorin, which is dosed along with 5-FU - is being delivered as an end metabolite directly. It avoids having to go through metabolization into a form of folate that allows 5-FU to kill cancer cells, as lucavorin requires. And Virca said that lucavorin still does not work that well. In trials, CoFactor is dosed 20 minutes before 5-FU.
"What our discovery was through the University of Southern California, who did this work, [was] that you could actually take this very interesting metabolite that goes in and out of equilibrium in vivo and you could freeze it in the form of a drug, and that's what we've been able to do, is to have a stable formulation," Virca told BioWorld Today.
However, Virca said the company will apply in the U.S. and UK for trials of CoFactor in pancreatic cancer. And he expects that the company will approach the FDA with a new drug application first for CoFactor in that indication.
The company expects to soon start a trial of BlockAide/CR, a viral entry inhibitor in patients on HAART therapy who are showing resistance by increases in viral load.
The company also has Thiovir, a pyrophosphate analogue for HIV/AIDS, for which an IND is expected to be filed in the third quarter for a Phase Ib/IIa trial, along with EradicAide, a therapeutic vaccine, for which the company also is expecting to file an IND in the third quarter for a Phase Ib/IIa study. In preclinical testing, Adventrx has another viral entry inhibitor, BlockAide/VP, and an alkylating agent for drug-resistant cancers called Selone, aimed at a market estimated at $1 billion a year.
Adventrx has 11 full-time employees and contracts out its research, supporting two scientists at M.D. Anderson Cancer Center, at which the company funds their work on BlockAide and EradicAide. It has two scientists at the University of Southern California who are working on Thiovir.
Although the company rents laboratory and animal space in San Diego, Virca said he expects the company will move into larger facilities in June.