Date: Mar 14, 2014 Author: A-J Media Source: Amarillo Globe-News (
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Local cancer patients could have the option to try a "natural" alternative to chemotherapy and other drugs for cancer treatment.
The Food and Drug Administration has approved a cancer vaccine developed by local doctors to go to clinical trials.
The vaccine, identified as the Kiro VAX series, will be available in clinical trials in Lubbock in May, said Dr. Scott Dahlbeck, chief executive officer of Kiromic LLC, the company that developed the vaccine.
"We've done all the preclinical work to present it to the FDA," Dahlbeck said. "The FDA gives approval called an IND (Investigational New Drug). … You can't even study it in humans without all that."
The company received the FDA approval notice by email on Feb. 6, Dahlbeck said.
Jennifer Rodriguez, press officer in the office of media affairs for the FDA, said in an emailed statement following an inquiry about the drug, "Federal law prohibits the FDA from confirming the existence of, or releasing information about, an Investigational New Drug application."
The vaccination has shown positive testing results so far, Dahlbeck said.
It works by using proteins from tumor cells to fight back against cancerous cells, he said. It will be administered through a series of shots.
"We've isolated the proteins that come off of these tumor cells," he said. "By identifying that, we're able to use that against the tumor to test it in the blood stream and detect it early. We're able to use it in the cancer cell to detect it. … It stimulates the blood cells to attack any form of tumor or entity that it's been exposed to through the vaccine. There are vaccines that take blood cells from the patient, expose it to the protein, so in other words, we're taking those white blood cell soldiers out, saying ‘this is the protein you need to attack.' "
The process used by Kiromic to develop the vaccine is patented, Dehlbeck said.
Tests have shown the drug is not toxic like traditional cancer drugs, he said.
"Helping the body help itself," Dahlbeck said. "It's sort of natural … it uses a natural form of treatment rather than toxic chemo radiation (or) rather than take a knife to cut it out."
Vaccinations will be manufactured and distributed from the Kiromic LLC facility, Dahlbeck said.
"We may have to purchase some things in other labs or chemical companies, but the actual vaccine will be here," he said.
The vaccinations have been engineered to work on any type of cancer in adults, he said.
Lab tests seem promising, but the drug still has a few hurdles to jump before it's completely approved for use by the general public, Dahlbeck said.
Kiro VAX is entering the first phase of FDA approval, Dahlbeck said. The first phase proves safety and the second phase proves it works. Phase three is a comparison to other drugs available, he said.
The trials are currently scheduled to start in Lubbock in May, Dahlbeck said.
"It'll be held right here in Lubbock," he said.
If results are positive, the vaccination could eventually be tried outside the state and even worldwide, he said.
The founder of the company, Dr. Maurizio Chiriva-Internati, began working on the development of the drug about 15 years ago, Dahlbeck said.
Phone calls to Chiriva-Internati went unanswered.
Dahlbeck said Kiromic is also working on other products.
"I think it's important to note we have a whole product pipeline," he said. "We have a whole diagnostic group of products. … I would like the public to know that we have an investment opportunity to make these products possible."
Dahlbeck said the vaccination is not a cure for cancer, though he hopes someday it could be.
"It's not a preventative vaccine, but it's one that's used for patients that have already been diagnosed with cancer," said Jerry Hudson, founding dean emeritus of Texas Tech. "It's an amazing type of discovery they've made that will impact cancer patients in a positive way in a sense of radiation and chemotherapy and stuff like that."
