FW firm in clinical trial for pancreatic cancer treatment

The survival rates of patients with pancreatic cancer have been gradually improving over the decades, but the disease still is considered largely incurable. That’s because diagnosis is difficult and often does not occur until the cancer has spread and attacks another organ that can feel and transmit pain.

But what if there were a way to prevent precancerous cells from becoming cancer?

That’s the thrust of a new clinical trial by NanOlogy, the company formed in collaboration by DFB Pharmaceuticals of Fort Worth, CritiTech Inc. of Lawrence, Kansas, and US Biotest Inc. of San Luis Obispo, California, to finance and clinically test a patented nanotechnology process to deliver proven cancer-fighting drugs to specific areas without the usual side effects of traditional chemotherapy.

NanOlogy announced Nov. 7 that the first patient had been enrolled in a Phase 2 clinical trial of NanoPac – the nanoparticle version to the cancer drug paclitaxel – to evaluate its safety and effectiveness on mucinous

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cystic neoplasms (MCNs) of the pancreas.

“Pancreatic cysts are diagnosed in more than 500,000 people annually in the U.S. and their diagnoses are increasing as advances in imaging technology have made abdominal imaging more common,” NanOlogy said in a news release. “MCNs are a subset of neoplastic pancreatic cysts and may progress to pancreatic cancer, which kills 90 percent of patients within five years of diagnosis.”

The Mayo Clinic reports on its website that pancreatic cysts are typically found during imaging testing for another problem.

The Phase 2 dose-rising trial will evaluate the safety and preliminary effectiveness of NanoPac delivered directly into MCNs by endoscopic ultrasound-guided fine needle injection, NanOlogy said in the announcement.

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“There is no approved drug treatment for patients with MCNs who are at high risk for progression to cancer,” said DR. Gere diZerega, vice president of medical affairs for NanOlogy. He said the clinical trial is the first study in humans to examine whether NanoPac injected directly into cysts will safely treat the cyst with a high and sustained concentration of the drug.

The NanOlogy process reduces the size of paclitaxel and docetaxel particles – the active pharmaceutical ingredient in chemotherapy – by up to 400 times. These particles can be suspended in a saline solution and injected directly into tumors, or, in this test, cysts.

That’s important because paclitaxel and docetaxel themselves are toxic to humans, and so is the solvent used to thin the chemicals enough to allow them to be injected into the blood vessel system.

In traditional chemotherapy, the body immediately begins to eliminate the drugs and they remain in the body at a level high enough to be effective against the cancer for only about eight hours. And the treatment itself can make the patient so sick that chemotherapy can only be repeated once a week or less.

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What NanOlogy is trying to prove in the clinical trials is that the cancer drugs will remain in the body at therapeutic levels for up to a month without the serious side effects of traditional treatment.

Patients with MCNs who are deemed at high risk for progression may undergo surgical resection of the pancreas to remove the cyst in surgery known as the Whipple procedure, named after Dr. Allen Whipple, a Columbia University surgeon who was the first American to perform the operation in 1935.

“The Whipple procedure can take several hours to perform and requires great surgical skill and experience,” says the medical website WebMD. “The area around the pancreas is complex and surgeons often encounter patients who have a variation in the arrangement of blood vessels and ducts.”

The Hirshberg Foundation for Pancreatic Cancer Research, a national nonprofit organization dedicated to advancing pancreatic cancer research and support for patients and their families, says there is “increasing evidence that the best pancreatic cancer outcomes are achieved at major medical centers with extensive experience — those that perform more than 20 Whipple procedures annually.”

The American Cancer Society (ACS) estimates that in 2017 about 53,670 people (27,970 men and 25,700 women) will be diagnosed with pancreatic cancer and that about 43,090 people (22,300 men and 20,790 women) will die of pancreatic cancer. Pancreatic cancer accounts for about 3 percent of all cancers in the United States and about 7 percent of all cancer deaths. ACS reports that the average lifetime risk of pancreatic cancer for both men and women is about 1 in 65 (1.5 percent).

ACS statistics say that for all stages of pancreatic cancer combined, the one-year relative survival rate is 20 percent and the five-year rate is 7 percent.

“These low survival rates are attributable to the fact that fewer than 20 percent of patients’ tumors are confined to the pancreas at the time of diagnosis; in most cases, the malignancy has already progressed to the point where surgical removal is impossible,” the Hirshberg Foundation said.

“In those cases where resection can be performed, the average survival rate is 23 to 36 months. The overall five-year survival rate is about 10 percent, although this can rise as high as 20 percent to 35 percent if the tumor is removed completely and when cancer has not spread to lymph nodes.”

If successful, intracystic injection of NanoPac would represent an alternative to surgery for these patients, NanOlogy said in its news release.

“If we are successful, we may offer the first drug treatment for high-risk MCNs, which would help fill an unmet need in this increasingly diagnosed condition,” said Marc Iacobucci, a managing director of NanOlogy.

NanOlogy has a broad clinical development program underway for NanoPac sterile suspension, including clinical trials in ovarian cancer, prostate cancer, pancreatic cancer and pancreatic mucinous cysts. In addition, NanOlogy and its affiliate, DFB Soria, are progressing clinical trials for Soria-developed SOR007 ointment (nanoparticle paclitaxel) in cutaneous metastases and actinic keratosis.

Clinical trials for NanoDoce – nanoparticle docetaxel – are planned in 2018 pending U.S. Food and Drug Administration approval, the company said in the news release. An inhaled version of NanoPac is in a preclinical pharmacology study for lung cancer.

In related news, Rexahn Pharmaceuticals Inc. of Rockville, Maryland, announced that it has dosed the first patient in a Phase 2a clinical study of RX-3117 in combination with Abraxane in patients newly diagnosed with metastatic pancreatic cancer who have had no prior chemotherapy. Abraxane – albumin-bound paclitaxel – is commonly used to treat pancreatic cancer in combination with other chemotherapies, the company said.

“With the initiation of this study, we are exploring the potential of RX-3117 in patients newly diagnosed with metastatic pancreatic cancer who have not been treated previously with chemotherapy. This is the largest patient segment, accounting for 60 percent of all pancreatic cancer patients, and this patient population potentially may benefit most from treatment with RX-3117,” Peter D. Suzdak, CEO of Rexahn, said in a release.

“There is a strong clinical rationale for combining RX-3117 with Abraxane,” said Suzdak.

“We know that drugs with a mechanism of action similar to RX-3117 work well in combination with Abraxane,” said Dr. Ely Benaim, chief medical officer of Rexahn, in the release. Not all patients can tolerate combinations with Abraxane due to toxicities, he said.

“A major advantage of RX-3117 is that it selectively targets cancer cells and has been shown to be safe and well tolerated in Phase 1 and 2a clinical trials. Our goal is to be able to treat patients with higher doses of both Abraxane and RX-3117, allowing them to stay on treatment for longer periods of time, leading to a better clinical outcome,” Benaim said in the statement.