PharmaCyte Biotech Shares Rise As Next Clinical Trial for Pancreatic Cancer is Designed

PharmaCyte Biotech Shares Rise As Next Clinical Trial for Pancreatic Cancer is Designed

By: Tomas Ronolski - AllPennyStocks.com News

Thursday, October 15, 2015

Pancreatic cancer is a nightmare. Even with the current “gold standard” treatment of gemcitabine and nab-paclitaxel (Abraxane®), the American Cancer Society lists the five-year survival rate (the percentage of patients that live at least five years after diagnoses) for patients diagnosed at Stage 1A (early stage) as only 14 percent. As with most cancers, the later the cancer is found, the lower the five-year survival rate. In the case of Stage 4 patients, only 1 percent live at least another half-decade. Companies are looking for innovative ways to treat pancreatic cancer, a disease that is often silent in onset and resulted in about 40,500 deaths in 2014, according to Cancer.net. Making matters worse, there are no specific, cost-effective screening tests to easily and reliably detect early stage disease in people showing no symptoms. Aduro Biotech (NASDAQ:ADRO) is targeting several types of cancer in its immunotherapy pipeline, including two, separate mid-stage trials of its CRS-207; one in combination with GVAX alone and another with GVAX plus the checkpoint inhibitor nivolumab for pancreatic cancer.


PharmaCyte Biotech Inc. (OTCQB:PMCB) is bringing their own novel pancreatic treatment into the mix, developing their novel cell encapsulation technology dubbed “Cell-in-a-Box®” to address the unmet medical need. Cell-in-a-Box is a proprietary cellulose-based live cell encapsulation technology, which the company believes can be served as a platform to treat several cancers and diabetes. Encapsulation technology is not new, but PharmaCyte is overcoming some obstacles with Cell-in-a-Box by using capsules primarily made of cellulose, a bio-inert material that doesn’t spark an immune system attack of damage surrounding tissue where the capsules are inserted.

For a small company, it’s worth noting that PharmaCyte has some leading scientists in its corner, including Dr. Daniel Von Hoff, Chief Development Officer at Translational Drug Development (TD2) through a Master Service Agreement with TD2. The venerable Dr. Von Hoff and his colleagues have been involved with the early development of many common cancer treatments today, including, but not limited to, mitoxantrone, fludarabine, paclitaxel, docetaxel, gemcitabine, irinotecan, nelarabine, capecitabine, lapatinib and others. Serving as Chairman of PharmaCyte’s Scientific Advisory Board is Dr. Matthias Löhr, the Professor of gastroenterology and hepatology at the famed Karolinska Institute in Stockholm, Sweden who served as the Principle Investigator for the Phase 1/2 and Phase 2 clinical trials of Pharmacyte’s pancreatic treatment. The SAB also includes Dr. Manuel Hidalgo, Director of the Gastrointestinal Cancer Clinical Research Unit at the Spanish National Cancer Research Centre (CNIO), Vice Director of Translational Research at CNIO and the Director of the Clara Campal Oncology Center in Madrid.

The early trials provided compelling data showing PharmaCyte’s therapy, which combined Cell-in-a-Box with a low dose of the cancer drug ifosfamide, can improve outcomes as compared to historical data used in the approval of gemcitabine. As such, investors are looking for the next step down the clinical path.

PharmaCyte said on Wednesday that based upon the information and guidance provided by the aforementioned TD2 and scientific advisors that it is designing the upcoming clinical trial to determine whether its pancreatic cancer combination can provide a benefit to pancreatic cancer patients when the “gold standard” treatment is no longer effective. Presently, there is no adequate alternative treatment available for these advanced stage patients. Given the low survival rates, this is the majority of pancreatic cancer patients.

In addition to anti-tumor activity, PharmaCyte also intends to evaluate the effect of its treatment on the development and progression of pain associated with pancreatic cancer. With this approach, PharmaCyte can eliminate the need for a separate trial, which it was originally planning to conduct, saving money, time and other resources. Unbearable and untreatable pain affects about one-quarter of pancreatic cancer patients.

“We are extremely grateful to TD2, Dr. Löhr and Dr. Hidalgo for their insight and guidance in designing our clinical trial. We believe that their identification of the opportunity for our pancreatic cancer treatment to satisfy a critical unmet medical need will give our pancreatic cancer treatment the greatest opportunity for success,” said Kenneth L. Waggoner, CEO at PharmaCyte in today’s release.

Shares of PMCB have traded as high as 27 cents in the past 52 weeks and hit a low of 7 cents late in September. A resurgence has followed the low, with shares climbing as high as 13 cents in Wednesday action before closing at 12.25 cents for a gain of 5.8 percent on the day. Shares have recently climbed over their 50 day moving average and today tested their 200 day moving average for the first time since April.

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