‘We were able to show in vitro and in lab mice that IgG manufactured from the plasma of the vitiligo donors, can prevent the melanoma cells from growing and spreading in a mouse melanoma model’ – GammaCan CEO Patrick Schnegelsberg.Melanoma is the least common but the most deadly skin cancer, accounting for only about 4% of all cases, but 79% of skin cancer deaths in the United States. Current therapies are only moderately effective with response rates in the 10% to 20% range, and with severe side effects. But an Israeli company thinks it has developed a safe, novel therapy to target metastatic melanoma patients with Stage III and IV melanoma that will cut down the disease and prevent its spread.

GammaCan’s innovative approach to treating cancer and other diseases is based on using intravenous immunoglobulin (IgG), a safe, non-toxic human plasma-based derived product that can be administered repeatedly. IgG works by strengthening the patient’s immune system, and many medical experts view immunotherapy as a future alternative to today’s standard chemotherapy.

Over the last two decades, IgG-based therapies have been approved for the treatment of a number of immune deficiencies and autoimmune diseases. But according to the company’s CEO Patrick Schnegelsberg, GammaCan is the first to use IgG to treat cancer.

But he adds that what makes GammaCan’s therapy called VitiGam so unique and effective is precisely its difference from standard IgGs. Instead of being produced from the plasma of anonymous blood donors, it’s manufactured from the plasma of donors with an autoimmune disease.

“Vitiligo is a benign autoimmune skin condition affecting up to 2% of the general population – the most famous of which is Michael Jackson. People with vitiligo have IgGs floating around their system that destroys the pigment in their skin,” Schnegelsberg told ISRAEL21c.

GammaCan scientists – led by its founder Prof. Yehuda Shoenfeld – have shown that VitiGam – the ‘enriched’ vitiligo IgG – prompts potent anti-melanoma activity in both in vitro and lab mice melanoma models.

Shoenfeld, one of Israel’s most prominent physicians and scientists in the field of immunology, heads the Department of Internal Medicine and the Research Center for Autoimmune Diseases at the country’s largest hospital, Sheba Medical Center. He’s been one of the pioneers in researching the use of IgG as a treatment for cancer.

“Yehuda had been working for decades on the healing properties of plasma-derived IgGs to treat auto-immune diseases. And in 1998 ARP Biomed was established based on his research that showed administration of intravenous plasma-derived IgG can treat cancer,” Schnegelsberg said.

Following a restructuring process, the company was renamed GammaCan in 2004, and now includes GammaCan Ltd., the Israeli subsidiary – which is owned by GammaCan Inc. based in Delware.

“Schoenfeld’s original approach was to collect all the various IgGs of a particular plasma from a large group of donors – something like 6,000 – the concept being that you acquire a large repertoire of IgGs, some of which will attack cancer cells,” explained Schnegelsberg.

In phase two clinical trials conducted in Israel, GammaCan was able to stabilize melanoma in two stage-four melanoma patients out of eight total.

“These people were very sick – they failed conventional drug therapies, and some had gone through experimental therapies without success. But we determined that if you give them monthly IgG treatment, you can cause stable disease. Two out of eight in a situation like this is very encouraging,” said Schnegelsberg.

However, the big innovation in GammaCan’s evolution was still to take place, the result of some deductive reasoning by Shoenfeld.

“If we now know that the IgG from plasma from all donors have anti-cancer activity, what will happen if we take the IgG only from a preselected group of donors that we speculate may have anti-melanoma activity?” asked Schnegelsberg.

The researchers then went back to a specific population with the vitiligo skin condition because they knew from other trials that the pigment producing cells – called melanocites – are the same ones that turn into melanoma when exposed to enough sunlight.

“Yehuda said – let’s take the IgG from people with the extreme form, and let’s see if it also kills melanoma cells. And we were able to show in vitro and in lab mice that IgG manufactured from the plasma of the vitiligo donors, can bind the cells, and prevent the melanoma cells from growing and spreading in a mouse melanoma model,” said Schnegelsberg.

GammaCan is currently in contact with the FDA to gain approval for a 12-month trial of VitaGan which would include 100 patients and take place in 15 centers in the US, Europe and Israel. Schnegelsberg is hopeful that the trials will commence at the beginning of 2008.

The Swiss-born, US-raised Schnegelsberg commutes between GammaCan’s Israel and American offices, but says he’s trying to spend more time in the Kiryat Ono center. His limited exposure to the world of Israeli research has been an eye opener.

“Israel is among the world leaders in this research. I’d say per surface area, Israel has the world’s highest concentration of smart people, good ideas and good institutions,” he said.

“Its shortcoming that I’ve seen, at least in the biotech sphere – is in taking its brilliant ideas and successfully commercializing them. While there’s a great deal of entrepreneurship and ideas, what the young industry hasn’t had a chance to do is to have that trial and error process that the US biotech industry has had for 30 years of failing, building and trying again. I’m sure Israel will catch up, and we at GammaCan will do our best to see that happens.”

Last week, GammaCan announced the completion of a $6.5 million private placement with a group of investors lead by T.R. Winston & Company, LLC. While the company infrastructure is lean – with seven employees and most of their research outsourced to Sheba Medical Center and other Israeli facilities – GammaCan has reached a major milestone in its cancer research, according to Schnegelsberg.

“We’ve proven that you can take IgGs from a donor with vitiligo and it will act like an anti-cancer drug.”