Shares of San Diego-based Adventrx Pharmaceuticals Inc. plunged to a 52-week low Oct. 1 following news that the company’s treatment for metastatic colorectal cancer failed to meet clinical trial goals.
Shares of Adventrx, traded under the symbol ANX on the American Stock Exchange, fell $2.02, or 78.6 percent, to 55 cents Oct. 1.
Adventrx said its colon cancer treatment ANX-510, or CoFactor, failed in a Phase 2b clinical trial to meet its primary endpoint, or a reduction of the proportion of patients reporting at least one hematological or gastrointestinal side effect.
The drug was aimed at treating metastatic colorectal cancer, or colon cancer that has spread, or metastasized, through either the bloodstream or lymph node system to other parts of the body, such as the ovary, liver or lung.
CoFactor was designed as a replacement for leucovorin, a drug used to protect healthy cells from chemotherapy or to enhance the anticancer effects of chemotherapy.
Another more advanced clinical trial was also testing CoFactor as a first-line treatment of metastatic colorectal cancer. The company said in a statement that it was evaluating the full set of clinical data from the failed trial before it would make any decisions regarding the future of its CoFactor clinical programs.
In the meantime, Adventrx said it would focus its efforts on advancing its pipeline of antiviral and anticancer products.
Adventrx Chief Executive Officer Evan Levine said the company expected to announce results from ANX-530 trials, for the treatment of non-small cell lung cancer and other cancers, later this year, and, if positive, would submit a new drug application with the FDA next year.
In 2006, Adventrx reported a net loss of $29.3 million, or 40 cents a share, compared with a net loss of $24.8 million, or 41 cents a share, for the same period in 2005.
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Transdel Pharmaceuticals Inc. began trading under the symbol TDLP on the Over-the-Counter Bulletin Board on Oct. 1 following its merger with San Diego-based Trans-Pharma Corp.
As part of the transaction, Trans-Pharma became a wholly-owned subsidiary of Transdel, a pharmaceutical company focused on treating pain without the side effects.
In connection with the Sept. 17 merger, the company said it raised $4 million through the sale of common stock.
“What it enables us to do is advance the development of our lead program, Ketotransdel, for eventual FDA approval and to continue the development of our product pipeline,” said Dr. Juliet Singh, CEO of Transdel.
Ketotransdel, a topical non-steroidal anti-inflammatory drug, or NSAID, is intended to treat acute pain.
NSAIDs (pronounced “en-saids”) and Cox-2 inhibitors, a more controversial pain treatment following the withdrawal of Vioxx from marketplace shelves, represent a market of approximately $6 billion.
More than 30 million people worldwide use prescription and over-the-counter NSAIDs daily, although some run the risk of cardiovascular, gasterointestinal and other side effects.
The company said it intends to file documentation with the FDA for Phase 3 clinical trials in the first quarter of 2008.
Depending on the FDA’s acceptance, the company said it anticipates starting Phase 3 clinical trials as early as the first half of 2008.
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Testing HIV Vaccine:
Ichor Medical Systems Inc., a privately held company focused on advancing a system to increase the effectiveness of DNA drugs and vaccines, said it has entered into an agreement with two research organizations to test a promising HIV vaccine.
Under the agreement, the Aaron Diamond AIDS Research Center will evaluate the ability of Ichor’s TriGrid Delivery System to increase the abilities of the vaccine.
The International AIDS Vaccine Initiative will provide the DNA vaccine, which has already been tested in humans using conventional delivery methods, and provide selected monitoring and data-management support. The ADVAX vaccine was developed by both organizations.
The goal of the studies is to determine if the promising immune responses observed when ADVAX was delivered into animals can also be observed in humans.
An HIV vaccine has yet to make it onto the market but researchers are hopeful it could. Merck has spent the last two decades developing an HIV vaccine and Sanofi-Aventis is conducting trials in Thailand with results due out in 2009.
Establishing protective immunity against HIV is particularly challenging because it will likely require both antibody and T cell responses.
And while DNA vaccines may be well suited to elicit such responses, delivering sufficient vaccine into cells where the vaccine can do its work has posed significant challenges.
During the past five years, Ichor has been awarded more than $3.5 million in Small Business Innovation Research grants from the National Institute of Allergy and Infectious Diseases to advance the development of DNA vaccines for infectious diseases.
Additionally, Ichor was recently awarded two government contracts valued at more than $3 million to assist the Naval Medical Research Center and Army Medical Research Institute of Infectious Diseases in the development of infectious disease and biodefense vaccines. The only licensed biodefense vaccines being manufactured in the United States treat anthrax and smallpox, although agencies have been working to develop other medical countermeasures to biological threats.
“This is another example of the wide range of applications of our TriGrid technology,” said Ichor CEO Bob Bernard in a prepared statement.
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