This post was contributed by a community member. The views expressed here are the author's own.

Business & Tech

San Marino Biotech Firm Announces Progress Toward Cancer Drug Approval

Epeius Biotechnologies gains FDA Phase III status for a genetically driven tumor destroyer called Rexin-G.

A San Marino-based drug maker took another step forward in the FDA approval process, garnering Phase III status for a new cancer treatment that could serve as a viable alternative to chemotherapy, the company announced Feb. 28.

Rexin-G is primarily intended to eliminate malignant tumors on the pancreas as well as bone and soft-tissue cancers. The intravenous drug targets cancer for destruction through genetically driven nanoparticles that don't interfere with normal body processes and organs. According to privately owned Epeius Biotechnologies, this enables Rexin-G to attack cancer anywhere in the body.

"Within minutes of infusion, levels of Rexin-G increase rapidly inside the tumor," states a video on the company's website. "The nanoparticles then deliver their lethal payload—the killer gene—to cancer cells. This designer killer gene blocks cancer cell growth by inducing programmed cell death in millions of tumor cells."

Interested in local real estate?Subscribe to Patch's new newsletter to be the first to know about open houses, new listings and more.

In 2007 the Philippines approved Rexin-G to treat all tumors that resist chemo. Since 2003 when the drug began its FDA approval regimen, clinical trials have demonstrated "the product's overall safety over extended survival times and a notable lack of either safety issues or dose-limiting toxicities," according to an Epeius press release.

"What this means, in terms of clinical development, is that the Rexin-G product, with its advanced GMP manufacturing, bio-processing and final formulation, meets rigorous FDA standards for obtaining a marketing license in the future," Chief Medical Officer Dr. Erlinda M. Gordon said in a statement. "Epeius Biotech can now proceed with its strategic, diversified Phase 3 drug development program for pancreatic cancer, osteosarcoma and soft tissue sarcoma."

Interested in local real estate?Subscribe to Patch's new newsletter to be the first to know about open houses, new listings and more.

Despite Rexin-G's promising outlook, one critic questioned the company's premature attempts at marketing based on "stunning results" during Phase II. So far Epeius personnel and independent researchers tested the drug on less than 100 patients, documents show.

"If there is one cardinal sin in biotech communications, it is hype," CBS business blogger Trista Morrison wrote in 2009. "Apparently no one told Epeius Biotechnologies."

In addition to criticizing Epeius for hyping anecdotal evidence—a scientific no-no—Morrison argued that "telling late-night TV viewers you've made a miracle toaster is one thing; telling desperate and dying patients you've made a miracle cancer drug is quite another."

Morrison used press release quotes to illustrate the penchant for self-promotion despite Rexin-G's experimental status: "Rexin-G has once again accomplished what standard cancer treatments and even much-touted biologics have failed to do: that is, to bring forth the benefits of remission in otherwise intractable metastatic cancers."

Morrison also highlighted other choice bits of rhetoric: "the first real breakthrough in pancreatic cancer seen in years ... Rexin-G is the world's smallest hero! ... Epeius Biotechnologies draws the sword of targeted gene delivery system from the stone of chemistry and physics."

Dave Dornsife, CEO of Epeius' parent Herrick Corp. in San Ramon, Calif., declined to comment beyond the press release and said the company was "embarrassed" about charges of prematurely hyping Rexin-G in advance of FDA approval.

U.S. Food and Drug Administration spokeswoman Karen Riley said the agency does not comment on drugs in the approval process. For FDA documents detailing Rexin-G's clinical trials, click here.

We’ve removed the ability to reply as we work to make improvements. Learn more here

The views expressed in this post are the author's own. Want to post on Patch?