NDA For Cold-fX Could Follow Trial On Treating Cancer-Related Infections

CV Technologies would consider submitting a new drug application for its American ginseng extract following a National Cancer Institute-sponsored phase III trial on the effects of the ingredient on acute respiratory infection in certain leukemia patients.

The outcome of the randomized controlled trial of CV Technologies' Cold-fX product could influence whether the Canadian firm will pursue drug status for Cold-fX in the U.S., said Jacqueline J. Shan, president and chief scientific officer.

Supplement industry stakeholders say the trial also serves as another significant step for natural products industry and treatment of conditions related to cancer.

The trial, funded mainly by NCI with some support from CV Technologies, is slated to evaluate the efficacy and safety of Cold-fX in 336 chronic lymphocytic leukemia patients for three months beginning January 2009.

"We see there is potential for us to really develop our product for specially managing cold and flu infections in the cancer patient population," Shan, who also is CV Technologies' founder, said in an interview.

The firm has not drafted plans to seek drug status for Cold-fX, but Shan said a successful trial "would certainly open up that possibility for us to file" formal drug applications with FDA.

Cold-fX is currently sold as an approved natural health product for strengthening the immune system in Canada and as a dietary supplement in the U.S., where sales are "very insignificant" compared to the product's Canadian presence, Shan said.

Mark Blumenthal, executive director of the American Botanical Council, questioned whether an NDA would be in the company's financial interest, even with a successful trial.

"What many people might prefer to do is just leverage the public relations that could come out of such a hopefully positive outcome" and continue marketing the product as a dietary supplement, he said.

Shan said Edmonton, Alberta-based CV Technologies would likely formulate a new Cold-fX product for cancer patients should the trial bear fruit, rather than add to the claims listed for the existing product line.

In March 2007, ABC announced that scientific literature shows Cold-fX's ginseng-derived active ingredient, CVT-E002, has potential prevention efficacy against acute respiratory infection and no evidence of risks that would necessitate label warnings (¹ 'The Tan Sheet' March 12, 2007, In Brief).

CV Technologies' 2007 annual report says management is weighing whether to seek FDA approval of Cold-fX as an OTC drug for cold and flu.

The report adds that existing clinical data on the ingredient may negate the need for extensive additional studies and thereby drop the cost of pursuing drug status significantly below the firm's estimate of $20 million to $30 million.

A Crucial Trial

In a Nov. 17 release, Kevin High, one of two researchers at the Wake Forest University School of Medicine who will coordinate the study across multiple U.S. sites, explains that immune dysfunction in chronic lymphocytic leukemia sufferers leads to frequent acute respiratory infections that typically prove expensive and difficult to treat.

"The weakened immune system means vaccines don't work as well in these patients, so alternate means of preventing infection are an urgent need," High says.

CV Technologies notes "NCI accelerated the process" after approving the study by recruiting subjects through its full network of more than 1,500 trial sites.

Barton Kamen, chief medical officer for the Leukemia & Lymphoma Society, highlighted the importance of finding an alternative to antibiotics or vaccines, against which cold and flu viruses can build immunity, for treating respiratory infections in chronic lymphocytic leukemia patients.

"Keeping your own immune system strong is a good thing, if we knew how to do it," he said.

Additionally, he said cancer patients often do their own research and take excessive amounts of complementary and alternative substances such as vitamin E. This can work against prescribed oncological treatments by altering the body's metabolism.

Although complementary and alternative substances "complicate things, it doesn't mean they're not good," Kamen said. "If they have potential, we need to study them under controlled conditions."

A Widening Doorway

The evidence of ginseng's efficacy against cancer's effects is accumulating. A study published in the American Journal of Epidemiology April 2006 showed a 30 percent higher survival rate for breast cancer patients who regularly took ginseng (² (Also see "Ginseng Study Suggests Improved Breast Cancer Survival Rate" - Pink Sheet, 3 Apr, 2006.), p. 11).

Additionally, a study by Mayo Clinic researchers found American ginseng appeared to increase vitality in cancer patients (³ (Also see "Ginseng Reduces Cancer Fatigue, Could Be “Valuable Addition” – Study" - Pink Sheet, 4 Jun, 2007.), p. 14).

According to Blumenthal, the NCI study "helps widen the already opening door in the area of using herbal dietary supplements for cancer patients."

He added that the seemingly "staid scientific culture of NCI" actually includes a number of medicinal plant experts seeking botanical sources of new oncology drugs.

In addition to ginseng, Kamen said he sees anti-cancer promise in epigallocatechins found in green tea, curcumins found in spices and the herbal derivative artemisinin, which is already used as an anti-malarial.

CV Technologies' strategies could be a good model to other natural product firms interested in developing products for cancer patients, Blumenthal pointed out.

By investing in clinical studies of Cold-fX ahead of marketing, CV Technologies follows more the model of a European phytomedicine operation than a dietary supplement firm, he said.

The company also conducts the research on its own proprietary extract, meaning its claims carry more weight and are not based on studies that may not be applicable.

"The marketing follows the clinical and pharmacological research they've invested in," Blumenthal said. "It's not smoke and mirrors."

- Dan Schiff ([email protected])