ADVENTRX Pharmaceuticals, Inc. (formerly Biokeys Pharmaceuticals, Inc.) is the result of a merger, effective in the State of Delaware on October 10, 2000, between BioQuest, Inc., which was a public company, and Biokeys, Inc., which was a privately held entity. To consummate a merger of equals, the two companies adjusted outstanding shares, options, and warrants on a 50/50 basis. Intellectual properties, technologies, and personnel resources were then combined to create a leading-edge biopharmaceutical company with products ready for on-going human trials and a pipeline of products for future growth.
In June 1996, the Company signed an exclusive worldwide Patent and Technology License Agreement with The University of Texas M.D. Anderson Cancer Center for all rights relating to the commercialization of technologies described in seven patents and patent applications in the field of HIV therapy and vaccine development. In January 2001, the Company signed an amendment to the Agreement for additional licensed subject matter and first right of refusal to license any technology developed by the scientists and labs covered in the original Agreement.
The Company entered into an Option and License Agreement with the University of Southern California (USC) in January 1998 for exclusive worldwide rights to conduct technical, preclinical, marketing, patent and other studies with respect to products covered by three patents for anticancer agents. In August 2000, The Company signed an amendment to the Agreement regarding ongoing patent prosecution and maintenance. The Company also holds a worldwide license from USC to practice the inventions covered by five patents related to antiviral products. An Option and License Agreement was signed in August 2000 and the option was exercised in November 2000 for exclusive rights to the antiviral technology.
In May 2002, the Company became a fully reporting company and in June 2002 announced that the Company's Common Shares were accepted for quotation on the NASD Over The Counter Bulletin Board.
In July 2002, the Company announced that it had been granted an exclusive, worldwide license by the United States Public Health Service National Institutes of Health (NIH) for technology and patents that complement patents and technologies licensed by the Company from the University of Texas M.D. Anderson Cancer Center for the drug BlockAide/CR.
In June 2003, the Company was renamed ADVENTRX Pharmaceuticals, Inc. and is currently traded on the over the counter Bulletin Board under the trading symbol "AVRX."
In April 2003, the Company signed an Amendment to its Option and License Agreement with USC, which eliminated minimum royalties prior to commercial sale of any of the products under the license, and eliminated the escrow account, which was replaced by milestone payments based upon products moving into clinical trials. The new Amendment also includes broader rights to antiviral applications and to drug delivery of antiviral and other therapeutic compounds.
MISSION & STRATEGY
ADVENTRX refines therapies through either replacement chemistry, using our leading-edge combinatorial synthesis methods, or through newer and more innovative biological approaches, such as those which trigger the immune system or prevent the infection phase of viruses. The Company holds exclusive rights to three platform technologies for drug discovery, two new cancer drugs, a new class of broad-spectrum antivirals with antiviral and anticancer properties, and four new agents HIV/AIDS therapy. Coupled with these technologies and products is an experienced biopharmaceutical management team, with significant clinical and FDA-related expertise and a track record of numerous commercial successes.
TARGET TECHNOLOGIES
ADVENTRX Pharmaceuticals, Inc. is a biopharmaceutical research and development company whose business strategy is to commercialize leading edge medical research through licensing agreements with prominent universities and research institutions. The Company is focusing its resources on anticancer and antiviral research to launch products that either extend the usefulness of current therapies or replace marginal therapies with new approaches to treatment. The Company's clinical and preclinical compounds are as follows:
| Product / Description | Development Stage | Indication | Target Market |
| CoFactor™ 5FU Biomodulator | Approved for Phase II targeted to begin QIV 2003 | Metastatic Colorectal Cancer | $450 Million per Year |
| BlockAide/CR™ Viral Entry Inhibitor | Phase Ib/IIa IND targeted for QIV 2003 | HIV/AIDS | $500 Million per Year |
| EradicAide™ Therapeutic Vaccine | Phase Ib/IIa IND targeted for QI 2004 | HIV / AIDS | $1 Billion per Year |
| BlockAide/VP™ Viral Entry Inhibitor | Pre Clinical | HIV/AIDS | $500 Million per Year |
| Thiovir™ Pyrophosphate Analogue | Pre Clinical | HPV (Human Papillomavirus) HIV /AIDS | $500 Million per Year $250 Million per Year |
| Selone™ Alkylating Agent | Pre Clinical | Drug-resistant cancers | $1 Billion per Year |
CoFactor
The Company's key anticancer drug is CoFactor. CoFactor dramatically enhances the anti-tumor effects of 5-FU (5-Fluorouracil), probably the most widely used cancer drug in the world, while reducing side effects compared to current therapies. With increased survival rates, improvements in patient quality of life, and demonstrated effectiveness for patients who have failed previous therapy with 5-FU/Leucovorin for metastatic colorectal and breast cancer treatments, CoFactor is well positioned to ultimately be approved as a new biomodulator for 5-FU combination chemotherapies. The drug received FDA approval to begin first line Phase II trials in the US for metastatic colorectal cancer which are planned to begin in QIV 2003. The Company anticipates that an NDA (new drug application) can be filed for CoFactor use with 5-FU for metastatic colorectal cancer in less than three years.
BlockAide/CR
ADVENTRX Pharmaceuticals has developed a peptide-based viral entry inhibitor, which stops HIV before it infects human cells, compared to all but one of the currently approved HIV drugs, which treat cells after they are infected. BlockAide/CR prevents HIV attachment to human cell-surface receptors, to which the virus would normally bind. This drug has been tested in non-human primates and has demonstrated the ability to reduce viral load by nearly 100-fold in acute infection. The Company intends to apply for IND approval in QIV 2003 to begin human trials of this compound in the United States. Drug product has already been manufactured under cGMP guidelines in an FDA approved facility. If later approved for marketing, the Company believes this drug could be administered as a monotherapy or synergistically with currently available HIV drugs used for HAART Therapy.
EradicAide
EradicAide is an antiviral drug that is antibody-negative. It relies on eliciting a cell-mediated immunity response to treat individuals already infected with HIV, while protecting against new infection. ADVENTRX Pharmaceuticals intends to apply for IND approval in the US in 2004 and thereafter seek approval for EradicAide under the FDA's Fast Track Program. This drug has shown significant effectiveness in multiple primate studies in which viral load has been suppressed for extended periods of time without repeated treatments. This product also holds great potential for AIDS therapy in third-world countries, where daily combination therapies are too costly and cumbersome to implement.
BlockAide/VP
The second viral entry inhibitor is BlockAide/VP, which disrupts the ability of a protein on the surface of HIV to begin the process of attachment to human cells. This drug has demonstrated the ability to dramatically reduce viral load in in vitro human cell testing as a monotherapy. It has also been tested in conjunction with BlockAide/CR as a combination therapy, against HIV infected human cells in culture, and demonstrated a synergistic effect in lowering total viral load.
Thiovir
A new broad-spectrum antiviral compound, Thiovir is the first in a series of orally and topically bioavailable compounds with the ability to inhibit a variety of viruses, including HIV, HSV (herpes viruses), CMV (cytomegalovirus) and HPV (human papillomavirus). Some of these viruses have oncogenic properties; therefore, treatment with Thiovir is both antiviral and anticancer in nature. Currently there is no existing approved antiviral treatment for HPV, which is associated with the development of genital warts and the pathogenisis of cervical cancer. The Company intends to continue research on Thiovir as a topical treatment for genital warts and later will focus on its use as an oral treatment for HPV-positive women who have abnormal pap smears and are therefore considered high-risk for cervical cancer. Additionally, Thiovir was designed to be an oral replacement for the HIV-IV drug foscarnet. It, like foscarnet, appears to have a limited resistance profile which could make it an important and effective component of HAART therapy.
Selone
Selone is the first in a series of anticancer compounds developed by ADVENTRX Pharmaceuticals for use with drug-resistant cancers. Because nearly one-half of all cancers now become resistant to current drugs, new classes of compounds are critically needed. The Company has conducted early preclinical testing of Selone, which has demonstrated full activity in human cell lines resistant to other cancer drugs, including antitumor antibiotics. Selone has the potential to move to human testing in the next several years.
ADVENTRX Pharmaceuticals will continue to focus its energy in cancer and viral research by providing products that extend the usefulness of current drugs and developing new compounds to fill the gaps where current treatments fall short. By solving problems such as drug resistance and improving the performance of current medical treatments, the Company intends to become one of the leading biopharmaceutical development organizations in antiviral and anticancer drug research. By continuing to refine therapies, ADVENTRX Pharmaceuticals may someday improve the length and quality of life for countless individuals.