Reformulation of nutraceutical aims at sales boost to help fund DIM drug development

15-Jul-2013 - Last updated on 16-Jul-2013 at 04:46 GMT

Berkley BioSciences Inc. has launched a new formulation of its ActivaMune immune health product, both to improve product performance and to boost sales to help fund ongoing drug development research on the formula’s prime active ingredient—diindolymethane (DIM)—which has been under investigation at the University of California for years.

“What we are selling is clearly a dietary supplement. Our goal is to sell a nutritional supplement with ingredients at dosages that we know will boost customers’ immune systems,” Michael Davallou, general manager of Berkeley BioSciences, told NutraIngredients-USA.

“In the meantime it is a fact that this chemical is under investigation for its clinical applications, including in the treatment of cancer,” he said.

Many benefits of DIM

The main active ingredient, DIM, is chemical found in broccoli and other vegetable of the Brassica family. The molecule has been found to have a number of potent properties, according to the Diindolylmethane Information Resource Center at UC Berkeley. These include:

Anti-inflammatory properties through the down regulation of NFK-B, a well-known inflammatory drug target with therapeutic properties for both cancer and cardiovascular disease.
Immune Activation through the induction of Interferon-Gamma Receptors and Interferon-Gamma itself which are well understood in the scientific community for their antiviral, antibacterial and anticancer properties.
Synergy with Interferon-Gamma in the induction of the MHC-I complex which helps to flag cancer and infectious disease antigens to the immune system for destruction.
The promotion of apoptosis through inhibition of PI3K /Akt. Apoptosis is programmed cell death. Normal cells have this process as a part of their life cycle but cancer cells lose this ability in the process of becoming cancerous. Hence it is an important mechanism by which cancer cells can be prompted to self-destruct.  
Promotion of P38 and P21 which promote cytostasis of cancerous cells.

Davallou said the company is well aware of the strictures attached to the marketing of a dietary supplement. The company is marketing ActivaMune as an immune health support, nothing more, he said.

Salad in a pill

The new formula includes 800 mg ActivaMune DIM complex, 800 IU vitamin D3, 60 mg vitamin C, 30 IU vitamin E, 50 mg calcium, 50 mcg selenium, 6mg lutein, 6mg lycopene, 500 mcg zeaxanthin and 300 mcg sulforaphane, another beneficial molecule found in broccoli sprouts, though mature broccoli contains little of the chemical. One serving of ActivaMune supplies the equivalent DIM dosage to eating five pounds of broccoli, according tot the company.

“The idea was to combine DIM with other nutrients that consumers would be exposed to if they ate a salad,” Davallou said.

As an immune system support, DIM works to help the immune system identify threats, priming it for more effective action when it is called upon. It does not provoke a response, and so can be used on a regular basis, unlike other immune health ingredients that raise the temperature of the immune system a notch, so to speak, leading to potential immune system fatigue with overuse.

“You are increasing the ability of the body to detect where issues may exist in the body and direct the immune system toward those issues,” Davallou said.

But DIM has a unique property, Davallou said. While priming the immune system, it can at the same time work toward quelled systemic inflammation.

“DIM increases the sensitivity of the immune system while simultaneously reducing inflammation,” he said.

From supplement to drug

Berkeley BioSciences sells the supplement via Internet sales channels, and response has been good, Davallou said.

“Sales have been excellent. We have worldwide recurring customers. We are fine-tuning the formula to meet market demand,” he said.

And while success with the nutraceutical application of DIM is welcome, it’s not the primary goal, Davallou said. UC Berkeley researches are involved in the company, and the product is licensed from the university. Sales of the supplement help fund ongoing cancer research into DIM.

“We’re not really a traditional supplement company. We have a nutraceutical division, which promotes ActivaMune, but we also have a pharmaceutical division. We are looking to make this into a pharmaceutical,” Davallou said.