Reversal of diabetes following transplantation of an insulin-secreting human liver cell line: Melligen cells

Bama, you had some great intuition this morning. An updated peer-reviewed article for you...

http://www.nature.com/articles/mtm201511

Absolutely fabulous interview with Dr Von Hoff! I had never seen it before. It gives great insight into how he approaches human trials by doing multiple layers which is exactly how he has designed our Phase 1. Thank you... Great DD, fros6!

Just an excerpt below. Entire interview attached...

The Complete Phase Ib Trial Design – An Approach for Getting to Phase II Faster

Medelis: Dan, you have evolved an approach to the phase Ib that has repeatedly shown to generate more useful information in less time, getting you to the phase II more quickly. How does it differ from the traditional phase I?

Dr. Von Hoff: The typical phase I approach is essentially serial drug development, which involves running multiple separate trials. Each site at each trial adds a layer of time, cost, and management oversight. What I call “the complete phase Ib” is a simple solution that essentially tests the various drug combinations in one phase Ib with multiple arms run in parallel.

For example, assume you have good preclinical data on a single agent that may be more effective in combination with another agent—for example, a monoclonal antibody plus gemcitabine (GEMZAR®). Most Chief Medical Officers anticipate that the pivotal clinical trials will be standard therapy with or without the new drug, and they prepare for that eventuality by conducting a phase I trial of the combination. Typically, this involves launching five, six, or sometimes more combination phase I trials. Each trial has to be negotiated and managed separately, and each must have its own protocol, adding layer upon layer of cost and effort.

The strategy I’m suggesting eliminates all these separate serial trials because it puts the combinations into one phase Ib trial.
http://www.medelis.com/clinical-cancer-research-abstracts/complete-phase-ib-trial-design/

In the end, bull, Cell in a Box technology stands on its own merits. It can neither be destroyed nor made a winner by anyone. The only thing that is happening while we await results, is trading... :)

Do not be deceived...

No problem. Just providing info so each person can decide for themself what they choose to believe.

In all my DD of Dr Von Hoff, I have not seen him quoted very much at all. In fact, this year old study is still making the front page of news on TD2s website.

Studies take time. This is a critical consideration when investing in biotechs.

http://www.td2inc.com

Thanks bull. Same to you... Your DD and support is appreciated by many and we know that Dr Von Hoff knows his way around the FDA very well. He was on their SAB.

"The Nuvilex team presents us with a new tool to employ against the symptoms and invasive properties of this very challenging cancer," said Daniel D. Von Hoff, M.D., Chief Development Officer of TD2. "Our Pancreatic Cancer Research Team (PCRT) colleagues are enthusiastic to begin clinical trials with this approach."

http://www.td2inc.com/news/nuvilex-selects-translational-drug-development-td2-to-advanc

This preclinical study will be conducted by Translational Drug Development (TD2) in the United States. Pancreatic cancer expert Dr. Daniel D. Von Hoff is the Chief Development Officer of TD2 and a principal architect of the study.

http://www.pharmacytebiotech.com/pharmacyte-biotechs-expanded-follow-study-malignant-ascites-fluid-accumulation-final-stages-preparation/

PharmaCyte, formerly Nuvilex...

"Two additional clinical trials will be conducted in the U.S. by Translational Drug Development (TD2). These trials will determine the effectiveness of PharmaCyte Biotech’s treatment in (i)reducing the severe pain that occurs in patients with advanced pancreatic cancer; and (ii) slowing the accumulation of malignant fluid (ascites) that accompanies the development of pancreatic and other solid cancerous tumors in the abdomen."

http://www.pharmacytebiotech.com/pharmacyte-biotech-on-track-to-commence-clinical-trials/

Wall Street BioBeat
Jun 1, 2012 (Vol. 32, No. 11)
Pain Management Market Ripe with Immediate Opportunities
Gail Dutton
The highly fragmented pain-management market poses an opportunity for new classes of drugs targeting neuropathic pain as well as for generics as standard therapies come off patent. Because current therapies are often less than effective or have undesirable side effects, there also are emerging opportunities using genomics to match patients to pain medications.

Pain management today is dominated by Pfizer, Eli Lilly, Purdue Pharma, Endo Pharmaceuticals, Novartis, Johnson & Johnson, and Grünenthal. “Among these, Purdue Pharma, Endo, and Grünenthal specialize in pain,” points out Karen Holmes, senior market analyst and author of the recent Espicom Business Intelligence report, Evolution in the Pain Therapy Drugs Market: Nociceptive and Neuropathic Drug Development.

“Pfizer is by far the biggest player, consolidating its position with the acquisition of King Pharmaceuticals and Icagen. Including line extensions, Pfizer has at least 10 compounds in clinical development for pain indications.”

Whether those leaders will manage to maintain their positions depends upon how they manage their patent expirations as well as new drug development. “You have to be paranoid about the competition. The science isn’t stopping,” says John Steuart, managing partner, Claremont Creek Ventures. “Thousands of biotechs and tens of thousands of academic labs are working to develop new therapies all the time.” Pain management, he admits, is a mature market, so new therapies must be proven more efficacious or less toxic than existing medications.

Market
Market projections vary, but Espicom estimated the global pain-management market at $46.4 billion at the close of 2011. The U.S. market accounts for 48% of that. Another market analyst, Global Industry Analysts (GIA), one year ago predicted the global pain-management market would reach $60 billion by 2015.

That predicted growth is based upon an aging global population, increasing number of surgeries, lifestyle changes, and a rising incidence of cancer. Some 1.5 billion of the world’s 7 billion people—21%—currently suffer from pain. That includes approximately 30% of all cancer patients and 60% of late-stage cancer patients.

The largest markets for pain-management medications currently are the U.S. and Europe. As with many pharmaceuticals, however, the fastest-growing markets are expected to be in Asia and Latin America, according to the GIA analysis, Pain Management: A Global Strategic Business Report. It anticipates a 9% compounded annual growth rate for pain-management therapies in Latin America between 2007 and 2015.

Neuropathic Pain
Click Image To Enlarge +

Shingles rash (red) and blisters (orange) on the chest of a 90-year-old man. Shingles (herpes zoster) is one of the major causes of neuropathic pain. [Dr. P. Marazzi / Photo Researchers]
“Approximately 3 to 4.5% of the global population suffers from neuropathic pain,” according to GIA. Neuropathic pain is cited frequently as an important niche market, especially as blockbusters come off patent. It is a frequent side effect of cancer therapies, but also results from such metabolic disorders as diabetes, infectious diseases like HIV/AIDS or shingles (post-herpetic neuralgia), entrapment of a nerve (as in carpal tunnel syndrome), or demyelination in multiple sclerosis.

Existing first-line therapies for neuropathic pain include Pfizer’s Lyrica® and Eli Lilly’s Cymbalta®, Holmes says. “In addition to oral therapies, topical lidocaine is first-line therapy for localized peripheral nerve pain.” However, “Neuropathic pain is notoriously difficult to treat with current therapies.” In fact, few therapies are approved specifically for neuropathic pain.

“Of the 75 pain therapies currently in clinical trials, about 26 target neuropathic pain,” Holmes says. Of those, six specifically target post-herpetic neuralgia, while others target diabetic peripheral neuropathy, central neuropathic pain due to spinal cord injury or multiple sclerosis (MS), neuropathic pain in cancer, lumbosacral radiculopathy, and painful neuropathies affecting AIDS patients. Developers also are targeting nociceptive pain, including osteoarthritis pain and chronic low back pain, according to Espicom.

“Sales of novel treatments are unlikely to entirely replace the revenue lost following patent expiry of the current top five. However, there will be opportunities in underserved niche market segments, particularly neuropathic pain, which typically fails to respond adequately to conventional analgesics,” according to Holmes.

Possibilities
Grünenthal made its mark last spring with the European introduction of Palexia® (tapentadol), billed as “the first new molecular entity developed for the oral treatment of severe chronic pain to be introduced in the EU market in more than 25 years.” Janssen Pharmaceuticals, a Johnson & Johnson company, licensed the rights for the U.S., and markets it as Nucynta® and Nucynta ER®. It received FDA approval for the extended release formula last summer.

Tapentadol combines a mu-opioid agonist and a norepinephrine reuptake inhibitor in one molecule to provide opioid and non-opioid forms of pain relief. It reportedly has fewer side effects than oxycodone and other popular opioid pain relievers.

Another pain-management therapy, an 8% capsaicin patch called Qutenza®, was just approved in Wales for the treatment of peripheral neuropathic pain. It has been approved in Europe and the U.S. since 2009. Astellas Pharma in March withdrew its application for extended indications from the EMA. It is marketed in the U.S. by NeurogesX.

Pharmacogenomics
“Personalization of pain therapies based upon rational tools is more exciting than either the development of new targets or the presence of generics,” according to Steuart, at Claremont Creek Ventures.

AssureRx is developing a decision-support tool for psychologists to enable rational selection of pain products that are safe and effective and based upon patient’s individual genotypes. Approximately 40 psychotropic medications are being evaluated. The project is scheduled for a soft launch by early summer.

Reformulations
“In recent years, drug development in pain therapy has been focused mainly on reformulations of existing therapies and alternative modes of drug delivery to improve the delivery, safety, and efficacy of existing drug groups,” Holmes says.

For example, in March, Endo Pharmaceuticals acquired the Johnson Matthey patent for oxymorphone hydrochloride, extending patent protection for Endo’s entire oxymorphone franchise through 2029, including its new crush-proof tablets. Other drug developers are extending their brands through new indications. A look at Pfizer’s pipeline reveals 14 pain therapies in development, of which five are for new indications or enhancements.

Opioid analgesics form the largest single category of drugs in development, with a focus on formulations designed to reduce the risk of abuse. “Despite safety concerns, opioids remain the mainstay of moderate-to-severe pain therapy so it’s no surprise that several companies are developing potentially safer products,” Holmes says.

As the current market leaders go off patents, generic competition will become increasingly relevant. “The growth in the generic market is largely the result of the looming patent cliff,” Holmes says. “There already are tentative approvals from the FDA for generic versions of major sellers like Lyrica (pregabalin) and Cymbalta (duloxetine).

“A U.S. District Court has issued an order that prohibits the sale of generic duloxetine prior to patent expiry in June 2013, but it’s likely the generic market for this drug will be hotly contested,” she says. “We know of eight companies with tentative FDA approval for their generic versions of this product to date, and there are ongoing patent infringement actions with respect to Lyrica, which is currently patented in the U.S. to 2018.”

One strategy, Holmes says, is OTC switching—re-launching a former blockbuster for OTC use. When Novartis did this with Voltaren® (diclofenac) in 1999, the prescription brand continued strong sales in emerging markets because the brand was trusted, yet OTC sales hit $791 million in 2010.

“Generic drug makers are sitting pretty now,” Steuart says. A 2011 Supreme Court ruling effectively exempts generic manufacturers from liability, reasoning that under the Hatch Waxman Act (which authorized generics) they have no control over the information on their labels. “That eliminates a huge liability for generics manufacturers.”

http://www.genengnews.com/gen-articles/pain-management-market-ripe-with-immediate-opportunities/4123/

Federal Government Finally Admits Cannabis Can Help Kill Cancer Cells

April 7, 2015
(ANTIMEDIA) Washington, DC — In a rare and largely unnoticed move, the federal government has admitted that cannabis is effective in shrinking certain types of cancer cells. The unexpected and groundbreaking declaration was made in a recent update to a National Institute on Drug Abuse information sheet on medical marijuana.

The NIDA statement reads:
…recent animal studies have shown that marijuana can kill certain cancer cells and reduce the size of others. Evidence from one animal study suggests that extracts from whole-plant marijuana can shrink one of the most serious types of brain tumors. Research in mice showed that these extracts, when used with radiation, increased the cancer-killing effects of the radiation.
The admission comes several months after a study demonstrated the effectiveness of cannabinoids in shrinking aggressive brain tumors. It also comes shortly after the Senate moved to end the federal ban on medical marijuana by making it a Schedule II drug instead of Schedule I (a Schedule I classified substance is considered harmful, addictive, and without medical benefits). In spite of this progress, the Department of Justice has insisted on enforcing the archaic ban–in violation of a law Congress passed last year that instituted protections for medicinal use).

In addition to the NIDA’s public acknowledgment, the government has made other admissions of the medical benefits of cannabis: it holds a patent on cannabinoids for use as antioxidants and neuroprotectants. In February of this year, the Surgeon General declared that the plant offers health benefits.
While the government has now openly admitted that cannabis can fight cancer, it should be noted that it knew this to be true as far back as 1974. That’s when it ordered a study on the matter but blocked further research when the results proved the plant’s positive potential. It suppressed similar evidence found in later federal studies conducted in the 1990s. Regardless, the recent admissions by the surgeon general, NIDA, and Congress reflect an evolving federal stance on the matter.
The updated NIDA fact sheet on medical marijuana also notes the effectiveness of CBD — a non-psychoactive cannabinoid — in treating ailments from Alzheimers Disease, inflammation and pain to seizures, mental disorders and substance abuse.
As Tom Angell, chairman of the Marijuana Majority said,
It couldn’t be any clearer that marijuana has medical value…When even NIDA and the surgeon general are acknowledging that marijuana can help people who are suffering, it is time for the Obama administration to reschedule the drug. The attorney general can initiate that process today, and there’s no reason for him not to, especially when polling shows that such a huge majority of Americans supports medical marijuana.

http://theantimedia.org/federal-government-finally-admits-cannabis-can-help-kill-cancer-cells/

Most recent update...

Nuvilex, Inc. Engaged in “Cutting Edge” Cannabis Preclinical Studies Using Model Compounds with Cell-in-a-Box

New York, NY – Nuvilex, Inc. (OTCQB: NVLX) isn’t letting the upcoming mid-term elections or the views in Washington, D.C., on medical marijuana slow down its research. The company is currently engaged in preclinical studies at the University of Northern Colorado (UNC) targeting Cannabis-based cancer treatments using Nuvilex’s Cell-in-a-Box® cellulose-based live cell encapsulation technology.
While waiting for a Schedule 1 license from the DEA in order to conduct research using marijuana, Dr. Richard M. Hyslop, Professor of Chemistry and Biochemistry at UNC, along with his colleague Dr. Corina Brown are conducting these preclinical studies using model compounds that are similar chemically to the components they are looking for in Cannabis.
Dr. Hyslop said in an interview with the Biz West Newspaper in Northern Colorado, that the idea is to use the model compounds to screen live cells in an effort to find those cells that can eventually be encapsulated. “The type of cell that we’re going to incorporate is going to have a particular type of activity that is capable of converting a component of Cannabis to an active anti-cancer drug. What the research involves is identifying the type of cell that is capable of doing that.”
The goal behind this research is to eventually create a treatment for “solid” tumors using constituents (cannabinoids) of the Cannabis plant and the company’s live-cell encapsulation technology, Cell-in-a-Box®. Initially, Nuvilex will target solid tumors of the brain and pancreas.
Dr. Hyslop has been involved in cancer research for more than 35 years and is leading a team of scientists from UNC in what Nuvilex’s CEO calls “cutting edge” research on behalf of the company. Dr. Hyslop, who is a member of the Scientific Advisory Board of Nuvilex’s subsidiary, Medical Marijuana Sciences, is the latest in the biotechnology arena to be impressed by Nuvilex’s Cell-in-a-Box® and the role it can play in targeted therapies.
The Cell-in-a-Box® technology offers a way to encapsulate live cells capable of converting anticancer prodrugs (those that require metabolic conversion into their cancer-killing forms in order to be effective) in protective, pin-head-sized cocoons.
Nuvilex is using the technology for its treatment for advanced, inoperable pancreatic cancer which combines Cell-in-a-Box® and the well-known anticancer prodrug ifosfamide. The company is preparing for late-phase clinical trials using its treatment in early 2015, but it is also using the same treatment in what the company hopes will be groundbreaking preclinical studies to treat the symptoms associated with abdominal cancers, namely slowing the accumulation of malignant ascites fluid common with these cancers, and treating the unbearable pain associated with abdominal cancers.
Drs. Hyslop and Brown will develop cancer treatments that combine the Cell-in-a-Box® technology with cannabinoid prodrugs instead of ifosfamide. Their efforts to understand the chemical and biochemical processes involved in the interaction of substances derived from a sustainable plant source, such as Cannabis, with sustainable live cell encapsulation (Cell-in-a-Box®) provides the opportunity to develop what Nuvilex is calling a “green” approach to treating cancers like pancreatic, brain, breast, and prostate cancer that affect hundreds of thousands of individuals worldwide each year.
For thousands of years, Cannabis has provided a sustainable source of fiber, food, energy and medicine. The Cannabis plant’s cannabinoid constituents, with the most recognized of these being tetrahdyrocannabinol and cannabidiol, have been documented to possess broad anti-inflammatory, antioxidant, analgesic, nerve-protecting and anticancer properties as well as other therapeutic applications.

http://www.stockmarketmediagroup.com/nuvilex-inc-engaged-in-cutting-edge-cannabis-preclinical-studies-using-model-compounds-with-cell-in-a-box/

"Progress is ongoing at the University of Northern Colorado in an attempt to identify a cell line that can be encapsulated using the Cell-in-a-Box(R) technology, which, in turn, can be used together with cannabinoid or cannabinoid-like prodrugs as a treatment for deadly cancers – such as brain and pancreatic cancer."

http://www.pharmacytebiotech.com/pharmacyte-biotech-provides-update-on-corporate-developments-and-progress-with-cancer-and-diabetes-programs/

Good to hear. You are well followed I know so it is good to see your interst here... Keep up the good work. I like your business model. :)

Really like seeing you here Wolf... Have you done DD on this one?

Thanks for sharing the potential change re: schedule 1 status for MJ.

http://www.pharmacytebiotech.com/pharmacyte-biotech-provides-update-on-corporate-developments-and-progress-with-cancer-and-diabetes-programs/

mick, human trials are scheduled to start 3Q of this year. However, before Pharmacyte, formerly Nuvilex, acquired exclusive rights to Cell in a Box technology, Austrianova conducted Phase I/II human trials for IPC with very good success. They went bankrupt before Phase III.

So, in 3Q of this year, we are scheduled to start 2 separate trials with TD2, pain associated with pancreatic cancer and slowing malignant ascites for abdominal cancers. The third will be a Phase 2b to continue where Austrianova's previous trials left off for IPC.

Some info for your reading pleasure regarding the above. Have a good day and thanks for your chart updates.

"The European Medicines Agency fast-tracked this treatment, which is licensed to Nuvilex (Silver Spring, Md.). Nuvilex plans at least two new trials based on earlier phase I/II and phase II trials with a total of 27 patients with advanced pancreatic cancer. In the first, patients received two courses of ifosfamide at one-third the regular dose plus a urological protectant after transplantation of 300 capsules. Median survival after diagnosis rose to 40 weeks, compared with historical control of 28 weeks with gemcitabine, and 1-year survival increased to 36%, compared with 18% for gemcitabine. Four patients also reported improved pain, six were unchanged, and three had slightly more pain (The Lancet, May 19, 2001). However, in a second trial doubling the dose of ifosfamide, patients did not tolerate the drug well. Median survival was only 33 weeks, and 1-year survival was only 23%, suggesting that the lower dose previously used was better (Pharmaceutics, August 15, 2014, online).

“However, nine of the 27 patients were alive after 1 year, and two of these nine patients were alive for 2 years or more,” Salmons said.

An Australian phase IIb trial will test for median survival time and 1-year survival in advanced disease compared with best current treatment, and researchers plan a phase I/II trial for ascites (fluid in the abdomen) in metastatic cancer."

http://jnci.oxfordjournals.org/content/106/12/dju417.full

"One of PharmaCyte Biotech’s clinical trials consists of a Phase 2b trial where PharmaCyte Biotech’s pancreatic cancer treatment will be compared “head-to-head” with the best available chemotherapy (Abraxane® plus gemcitabine) for advanced pancreatic cancer. The Phase 2b clinical trial will be conducted in Australia by Clinical Network Services (CNS). PharmaCyte Biotech’s pancreatic cancer treatment consists of encapsulating the genetically modified cells, using the Cell-in-a-Box® live cell encapsulation technology, and placing the capsules with the live cells inside them near the site of the cancerous tumor. The patient is then given an inactive cancer drug, ifosfamide, intravenously at one-third the normal dose. When the blood carrying the ifosfamide comes in contact with the encapsulated cells the ifosfamide is converted into its cancer-killing form.

Two additional clinical trials will be conducted in the U.S. by Translational Drug Development (TD2). These trials will determine the effectiveness of PharmaCyte Biotech’s treatment in (i) reducing the severe pain that occurs in patients with advanced pancreatic cancer; and (ii) slowing the accumulation of malignant fluid (ascites) that accompanies the development of pancreatic and other solid cancerous tumors in the abdomen."

http://www.pharmacytebiotech.com/pharmacyte-biotech-on-track-to-commence-clinical-trials/

Sorry about your loss, mick. I am looking forward to human trials in hopes that we can start saving lives from this deadly disease.

Did you know that Ken Waggoner's father also died of pancreatic cancer? I believe almost everyone alive today has lost at least one person they loved to some form of cancer.

If effective, the study and trials being done at TD2 will help patients with ALL abdominal cancers, if only to improve their quality of life during their last days.

I can hold for years while we await human trial results newmixer and we know that bios take time. Only short positions create urgency. I am not in an urgent position and I don't think trials with TD2 will take very long since we are testing for "quality of life" which should improve the pain associated with malignant ascites. The trials with TD2 will be using already approved FDA drugs.

The only advice I will ever give here is, make sure you only invest what you can afford to hold. Otherwise, you will be in an urgent position as a long and bios do take time to complete the necessary milestones before market value is realized.

And honestly, I don't care what the market thinks at this time. I will only be concerned with the market's opinion after human trials.

We need big money investors and they will only be interested in solid results from studies or trials. Longs can wait for that and we expect our market value to improve as those milestones unfold.

Yes we do, Marlee. :)

Scientists have created insulin-producing cells that could replace injections

Australian scientists from the University of Technology, Sydney (UTS), have created a line of insulin-producing cells that could eliminate the need for Type 1 diabetics to inject themselves with insulin.

The development on its own is pretty impressive, but the cells, which are derived from liver cells, are now on their way to being incorporated to a world-first bio-artificial pancreas after being licensed by US biotechnology company PharmaCyte Biotech last October.

PharmaCyte Biotech has already acquired something called the Cell-in-a-Box® system, which is basically a tiny cellulose-based ‘capsule’ that can house artificial cells and integrate them into a human body. This platform can be used to develop treatments for any disease where cells aren’t releasing the molecules they’re supposed to, but after acquiring the license to the insulin-producing cells, it's clear that PharmaCyte Biotech has set their sites on targeting Type 1 diabetes.

Type 1 diabetes or juvenile-onset diabetes is an autoimmune disease that occurs when a person’s immune system attacks their pancreas’s islet cells and prevents it from properly regulating the body’s blood glucose levels by releasing insulin.

The new cell line, called “Melligen” cells, is derived from human liver cells, which have been genetically modified to take over the role of the pancreas's insulin-producing islet cells.

"When a foetus develops, the liver and the pancreas form from the same endodermal origin," explained Ann Simpson from UTS:Science, who has been developing the cells over the past 20 years, in a press release. Which means that they should have the potential to do the same things as one another.

Early lab trials have shown that the genetically modified Melligen cells are able to release insulin in direct response to the amount of glucose in their surroundings - something that could help type 1 diabetics to live without daily injections and regulate their blood sugar levels naturally.

"My team and I are excited by the prospect of working with PharmaCyte Biotech to eliminate daily injections for insulin-dependent diabetic patients,” said Simpson in the release.

The next step for the company is for PharmaCyte Biotech to embed clusters of the Melligen cells into the Cell-in-a-Box® capsule, which is around the size of a pin head.

These artificial pancreases will then be transplanted into animals to test whether they can effectively integrate into the body and regulate insulin levels. After that, they can begin testing the technology in humans.

Several other groups are now working on artificial pancreases that use sensors under the skin, or even temporary tattoos to monitor blood glucose levels. But these systems all require a pump to control the amount of insulin required in response to these levels, rather than biologically sensitive cells.

It’s pretty exciting to see all the ground-breaking work on diabetes and insulin-producing cells finally be commercialized into a product that could directly change people’s lives.

http://upriser.com/posts/scientists-have-created-insulin-producing-cells-that-could-replace-injections

That would be nice... :)

Hey newmixwer, what is this countdown all about?

And may the "Quality of Life" be improved for all current and future stakeholders!

Common sense is very accurate, Bill. Enjoy your travels, new home and take care...

Always nice to hear from you bill. :)

http://www.thestreet.com/story/13103481/1/fdas-record-approvals-bode-well-for-pharmacytes-cancer-treatments.html

FDA's Record Approvals Bode Well For PharmaCyte's Cancer Treatments

BALTIMORE, Apr. 7, 2015 /PRNewswire/ -- Goldman Small Cap Research, a stock market research firm specializing on the small cap and microcap sectors, announced today that it has issued a new article on PharmaCyte Biotech, Inc. (OTCQB - PMCB), a publicly traded clinical stage biotechnology company focused on developing and preparing treatments for cancer and diabetes. To view the sponsored research article, along with disclosures and disclaimers, or to download it in its entirety, please visit www.GoldmanResearch.com.

In the article on the Company, analyst Rob Goldman outlines the impact of the FDA's recent moves on the biotech industry and the Company's standing.

"Biotech stocks have been on fire since the start of 2015 and there is no sign of the money flows abating anytime soon. The primary driver behind the rise in biotechs may be the Federal Drug Administration (FDA) itself. Last year, it approved 41 new drugs which, according to the organization's website, were the most in nearly 20 years. That figure is up from 27 in 2013---a 51% increase year-over-year. Could it be that the FDA has become more accommodating in its goal of more swiftly approving drugs for treatment of diseases, especially those that are rare and serious diseases? It certainly seems that quality of life, especially in the treatment of life-threatening diseases has emerged as a key determining factor, which sets up very nicely for PharmaCyte Biotech."

Well, as previously discussed, everyone has an opinion and no one really knows.

Given all we know, the example provided seems more likely to me. This may explain why they are not shaing too much info just yet.

INVESTOPEDIA EXPLAINS 'Confidential Treatment Order - CTO'
Companies would typically seek a CTO in order to keep information that would otherwise put it at a disadvantage, a secret. For example, a company may apply for such an order to keep information regarding a pricing arrangement made with a partner, secret, since competitors finding out this information may go after the partner with a more competitive price.

Read more: http://www.investopedia.com/terms/c/confidential-treatment-order.asp#ixzz3WYpweZp8
Follow us: @Investopedia on Twitter

The results to which you refer have to do with pain. Dr Von Hoff seemed to think it was worth a study to see just how much the "quality of life" could be improved with the proper treatment.

"Another approach aims to make pancreatic cancer an operable disease. Using “Cell in a Box” technology developed by Austrianova, in Singapore, this cell therapy delivers ifosfamide locally to the cancer. Ifosfamide has previously shown promise as a chemotherapy against pancreatic cancer, but its effective dose was too toxic to give patients systemically. Instead, in the “Cell in the Box” approach, patients receive one-third of the usual dose of ifosfamide. “Cell in a Box” contains genetically modified cells that express the drug-metabolizing cytochrome P450 and converts the ifosfamide to its active form at the site of the tumor, according to CEO Brian Salmons, Ph.D. A catheter delivers the “Cell in a Box” capsule containing these cells to capillaries feeding the pancreas. This system of local delivery and activation greatly reduces side effects.

The European Medicines Agency fast-tracked this treatment, which is licensed to Nuvilex (Silver Spring, Md.). Nuvilex plans at least two new trials based on earlier phase I/II and phase II trials with a total of 27 patients with advanced pancreatic cancer. In the first, patients received two courses of ifosfamide at one-third the regular dose plus a urological protectant after transplantation of 300 capsules. Median survival after diagnosis rose to 40 weeks, compared with historical control of 28 weeks with gemcitabine, and 1-year survival increased to 36%, compared with 18% for gemcitabine. Four patients also reported improved pain, six were unchanged, and three had slightly more pain (The Lancet, May 19, 2001). However, in a second trial doubling the dosof ifosfamide, patients did not tolerate the drug well. Median survival was only 33 weeks, and 1-year survival was only 23%, suggesting that the lower dose previously used was better (Pharmaceutics, August 15, 2014, online).

“However, nine of the 27 patients were alive after 1 year, and two of these nine patients were alive for 2 years or more,” Salmons said."

An Australian phase IIb trial will test for median survival time and 1-year survival in advanced disease compared with best current treatment, and researchers plan a phase I/II trial for ascites (fluid in the abdomen) in metastatic cancer.

This was actually in resonse to this message...

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112456133

http://jnci.oxfordjournals.org/content/106/12/dju417.full

Well there are many reports, not just from Goldman, that big Pharmas are always on the look out for novel treatments and they would prefer not to have the competition. We have a CTO (Confidential Treatment Order) that was reported last year after trials began.

There could be something in there that precludes us from sharing any info until a given point.

DEFINITION of 'Confidential Treatment Order - CTO'
An order that provides confidential treatment for certain documents and information, that a company would otherwise have to file. A confidential treatment order (CTO) is issued by the Securities and Exchange Commission (SEC) and may only be in effect for a certain period of time, rather than indefinitely.

INVESTOPEDIA EXPLAINS 'Confidential Treatment Order - CTO'
Companies would typically seek a CTO in order to keep information that would otherwise put it at a disadvantage, a secret. For example, a company may apply for such an order to keep information regarding a pricing arrangement made with a partner, secret, since competitors finding out this information may go after the partner with a more competitive price.



Read more: http://www.investopedia.com/terms/c/confidential-treatment-order.asp#ixzz3WYjnUcPO
Follow us: @Investopedia on Twitter

The first preclinical studies began circa Aug 20, 2014 and we got preliminary results on Nov 19, 2014. That is 3 months from reported start to reported preliminary results.

The expanded study reportedly started circa Feb 19. I was a month off last time in my own projected time frame. I expected to hear results by October. I was also anticipating hearing results by April this year. I may be off again and it could be more than a month before we hear how the second study went.

I believe the mice lived longer than expected in both studies because my DD has shown me that mice studies average about 3 weeks for this type of study.

However, there could be other activities that lengthen the study by over 2 months as happened in last year's study. I just have no idea what that would be unless they were still testing the mice.

There are no absolutes at this point. We just have to wait for official word. However, I do trust that the initial results were very good. I have also heard that a follow-up study is often done when the first results need to be confirmed. This usually happens when the first results were unusually good.

All I can say is, "Long live the Cell in a Box mice!" I will wait patiently to hear just how well they did.

BTW, it should be understood, and it is in the TOS, that everything said in this forum is the opinion of the person posting. Make sure this is understood when doing DD.

No absolutes - just waiting now. What we do know is previous Phase I/II were great and so was our first study last year with Dr Von Hoff. I don't see why we should expect any less with our expanded study. Even though this is a mice study, remember CiaB has already been tested on humans.

It should go without saying but I will anyway, all just my opinion.

http://www.pacificbiolabs.com/preclinical_timing.asp

LOL... I was actually hoping for some news today after the long weekend. The updates are important to us long term shareholders as we are still building our company from the ground up with Cell in a Box(R) technology.

We have two studies going on right now and the one with TD2 is so important for all stakeholders. We have heard the results from the first study were very good and so we did an expanded study in preparation for Phase 1 trials. So far, all we know is they were good. We also know, the longer it takes to hear the study results, the more likely the mice are doing well.

We are at about day 46. Yes, I am anxiously awaiting those results reported by TD2. But the longer we wait, the better the chances the results are amazing...

Thanks, Bio. Very well said...

Cell in a Box technology was co created and developed by Doctors Lohr, Gunzburg and Salmons...

Encapsulated Cells Expressing a Chemotherapeutic Activating Enzyme Allow the Targeting of Subtoxic Chemotherapy and Are Safe and Efficacious: Data from Two Clinical Trials in Pancreatic Cancer

J. Matthias Löhr 1,2, Stephan L. Haas 1,2, Jens C. Kröger 3, Helmut M. Friess 4, Raimund Höft 5, Peter E. Goretzki 6, Christian Peschel 7, Markus Schweigert 8, Brian Salmons 9,* and
Walter H. Gunzburg 9,10

http://sgaustria.com/wp-content/uploads/2010/11/GMP-Production-of-an-encapsulated-cell-therapy-product.pdf


http://www.researchgate.net/profile/Brian_Salmons/publication/264713608_Encapsulated_Cells_Expressing_a_Chemotherapeutic_Activating_Enzyme_Allow_the_Targeting_of_Subtoxic_Chemotherapy_and_Are_Safe_and_Efficacious_Data_from_Two_Clinical_Trials_in_Pancreatic_Cancer/links/53ec8f910cf24f241f158c67.pdf?ev=pub_ext_doc_dl&origin=publication_list&inViewer=true

http://www.nature.com/gt/journal/v5/n8/abs/3300671a.html

Dr Brian Salmons

Nuvilex, Inc. (OTCQB:NVLX), an international biotechnology company providing cell and gene therapy solutions for the treatment of deadly diseases, announced today that its subsidiary, Medical Marijuana Sciences, Inc., has appointed Brian Salmons, Ph.D., CEO and President of Nuvilex's partner Austrianova, to its Scientific Advisory Board.
Dr. Salmons, together with Professor Dr. Walter H. Gunzburg, invented and developed the live-cell encapsulation technology now known as Cell-in-a-Box which has been licensed by Nuvilex for the development of treatments for cancer and diabetes. It is expected that, given his expertise in this and other aspects of the development of disease treatments, Dr. Salmons will play a pivotal role as Medical Marijuana Sciences goes forward with its cannabis-based cancer treatments.
Dr. Brian Salmons received his Ph.D. in London. After research positions in the U.S.A., Switzerland and at the Ludwig Maximilian University in Munich, Germany, Dr. Salmons became the Scientific Director of the European biotech/vaccine company, Bavarian Nordic, and was intricately involved in taking the company to an IPO. Bavarian Nordic was sponsor of the Phase1/2 clinical trial in patients with advanced, inoperable pancreatic cancer that involved the use of the combination of live-cell encapsulation and the anti-cancer prodrug ifosfamide. The results of this trial showed that the combination was safe and efficacious. These results were reported in reputable scientific literature and can be viewed by clicking here (please scroll down and click on blue title opposite "121-131").
In 2002, Dr. Salmons co-founded the biotech company, Austrianova, originally a "spin-off" from the Veterinary Medicine University in Vienna. He was instrumental in obtaining orphan drug status from the European Medicines Agency for its lead cell encapsulation product. In 2007, Dr. Salmons co-founded and became the CEO and President of Austrianova Singapore Pte. Ltd., an independent company established in Singapore to further develop the live-cell encapsulation technology as products for a variety of indications such as various forms of cancer, diabetes, neurodegenerative, cardiovascular and infectious diseases. Dr. Salmons is the author or co-author of over 120 peer-reviewed scientific articles and inventor of 8 patent families.
Dr. Mark L. Rabe, Chairman of Medical Marijuana Sciences' Scientific Advisory Board, commented, "Dr. Salmons' acceptance of his appointment as a member of the Medical Marijuana Sciences Scientific Advisory Board is a major coup for Nuvilex. His complete knowledge of the Cell-in-a-Box encapsulation technology, and its many possible applications, will be invaluable as we strive to develop treatments for the deadliest of all cancers employing Cell-in-a-Box technology in combination with cannabis-based compounds."

http://www.researchgate.net/profile/Brian_Salmons

- See more at: http://baltimore.citybizlist.com/article/40357/nuvilex-appoints-brian-salmons-phd-ceo-and-president-of-austrianova-to-scientific-advisory-board#.dpuf

Dr Walter H Gunzburg

Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that Kenneth L. Waggoner, the Chief Executive Officer, President and General Counsel of Nuvilex, has been appointed Chairman of the Board of Directors and that Prof. Dr. Walter H. Günzburg has been appointed to the post of Chief Scientific Officer. In addition, as part of the Company's on-going transition to becoming a fully integrated biotechnology company, Chairman and Chief Financial Officer, Patricia Gruden, Directors Timothy Matula and Robert Bowker and Chief Scientific Officer Dr. Robert F. Ryan have resigned from their respective positions.
"On behalf of the management team and Board, I wish to thank Pat, Tim, Robert and Dr. Ryan for their invaluable contributions to Nuvilex and stewardship through this transitional period. Nuvilex has evolved from a developer of disparate products to a dedicated platform company leveraging its Cell-in-a-Box® cellulose-based live cell encapsulation technology to encapsulate cancer prodrug- and cannabinoid-activating cells that, in combination with these substances, can be used in developing targeted treatments for specific solid-tumor cancers and for diabetes," said Mr. Waggoner. "All of us at Nuvilex are steadfast and aligned in ensuring Nuvilex reaches its potential. To do so, we are in the process of bringing in seasoned life science professionals to facilitate Nuvilex's growth. To this end, it is a pleasure to welcome Prof. Dr. Walter Günzburg," concluded Mr. Waggoner.
Dr. Günzburg is the Co-Founder and Chairman of SG Austria, Chief Technical Officer of Austrianova and co-developer of Nuvilex's proprietary platform, Cell-in-a-Box®. He has also been a full Professor of Virology at the University of Vienna since 1996. Prior to starting Austrianova, Dr. Günzburg was the Director of the Christian Doppler Laboratory for Gene Therapeutic Vector Development. Before his directorship, he served as a scientific advisor to the international vaccine developer, Bavarian Nordic, and was also involved in their IPO. Other biotech companies that Dr. Günzburg has served in an advisory capacity include Paktis and Liponova in Germany and Tocagen in the United States. Currently, Dr. Günzburg is on the Board of ViruSure, a virus and prion testing company in Vienna that he co-founded. He has also been actively involved in European ethics and regulatory affairs in the fields of cell and gene therapy, as well as xenotransplantation, for many years.
"It has been my honor to serve Nuvilex in various capacities over my tenure at the company. I wish the new Board and Leadership Team all the best as Nuvilex continues to innovate and grow in the life science sector," commented Mrs. Gruden. Dr. Ryan, who was instrumental in bringing the Cell-in-a-Box® technology into Nuvilex, commented, "There have been significant developments within Nuvilex over the past several months that will enable rapid progress in developing treatments for cancer and diabetes using the Cell-in-a-Box® technology. I am pleased with these advances and believe that, ultimately, this technology will be used to help countless individuals around the world who suffer from these serious and even deadly diseases. I am gratified to have played a role in this worthy endeavor and am delighted to know the future of Nuvilex is in good hands."

http://www.researchgate.net/profile/Walter_Guenzburg

- See more at: http://citybizlist.com/article/210681/nuvilex-appoints-dr-walter-h-gunzburg-as-chief-scientific-officer#.dpuf

Dr Daniel Von Hoff
Nuvilex Retains TD2 to Conduct Preclinical and Clinical Studies

SILVER SPRING, Apr 01, 2014 (GLOBE NEWSWIRE via COMTEX) -- Nuvilex, Inc. (otcqb:NVLX), a clinical-stage international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that it has signed a Master Services Agreement with Translational Drug Development (TD2) pursuant to which TD2 will conduct preclinical and clinical studies in support of the development of Nuvilex's pancreatic cancer and other treatments utilizing Cell-in-a-Box technology.

"The Nuvilex team presents us with a new tool to employ against the symptoms and invasive properties of this very challenging cancer," said Daniel D. Von Hoff, M.D., Chief Development Officer of TD2. "Our Pancreatic Cancer Research Team (PCRT) colleagues are enthusiastic to begin clinical trials with this approach."

The PCRT, an affiliate of TD2, has the explicit mission to organize and accelerate the clinical development of new agents for the treatment of patients with pancreatic cancer. The PCRT members include laboratory and clinical researchers in the U.S. and Western Europe who share the passion to bring new advances to patients with pancreatic cancer as rapidly as possible, providing the only coordinated effort in the world dedicated to rapidly translating research discoveries into new treatments and supportive care for pancreatic cancer patients exclusively. To date, the PCRT consists of approximately 65 Oncology Clinicians, Surgeons and Researchers who are member-investigators of the PCRT and who represent 45 clinical research sites.

In commenting on TD2's work with Nuvilex, Kenneth L. Waggoner, Chief Executive Officer and President of Nuvilex, stated, "We are honored that TD2 and Dr. Von Hoff will play a pivotal role in the development of our treatment for patients with advanced pancreatic cancer that combines the proprietary Cell-in-a-Box live-cell encapsulation technology with the cancer drug ifosfamide. TD2 integrates world-class preclinical, clinical and regulatory expertise and provides unique drug development services aimed at minimizing the risk for its clients in the oncology drug development industry. In addition, access to the PCRT that is enabled by our association with TD2 will not only make Nuvilex's approach widely known, but should facilitate its development as we move forward. The sincere interest in our advanced pancreatic cancer treatment that has been shown by TD2 is particularly rewarding to all of us."

TD2 is a precision oncology Contract Research Organization (CRO) that provides innovative services for oncology-focused biopharmaceutical companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening diseases. TD2 has managed and conducted more than 60 early-mid phase clinical studies and has worked with more than 350 biotech and pharmaceutical companies worldwide.

TD2 has facilities for the preclinical and clinical testing of candidate cancer drugs and treatments, as well as expertise in regulatory affairs matters with agencies such as the FDA. TD2 has more than 200 established models of human cancers available for preclinical studies and develops comprehensive drug development plans for the most efficient pathway for successful clinical trials. In addition, TD2 has capabilities and expertise in all aspects related to the conduct and management of clinical trials. TD2's drug regulatory affairs capabilities include the preparation and maintenance of Investigational New Drug Applications (INDs) that are necessary prior to the initiation of clinical trials, support for obtaining "breakthrough" designations and "fast track, priority review and accelerated approval" filings for cancer drugs and treatments. The TD2 team has collective experience in filing more than 60 INDs in the U.S. alone. In countries outside the U.S., TD2 can provide filing and maintenance services for Clinical Trial Applications and Investigational Medicinal Product Dossiers.

http://www.td2inc.com/news/nuvilex-selects-translational-drug-development-td2-to-advanc

http://archive.azcentral.com/arizonarepublic/news/articles/20100808valley-cancer-doctor.html

Dr Matthais Lohr. PharmaCyte formerly Nuvilex

SILVER SPRING, Md., Oct. 6, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that noted European gastroenterologist and oncologist Dr. Matthias Löhr has agreed to serve as Chairman of Nuvilex's newly formed Scientific Advisory Board.

Dr. Löhr has been a full professor of gastroenterology and hepatology at the famed Karolinska Institute in Stockholm, Sweden, since 2007. He has served as Professor of Molecular Gastroenterology at the University of Heidelberg and was the Head of the Molecular Gastroenterology Unit at the German Cancer Research Center. Dr. Löhr has also worked as a translational scientist and Principal Investigator in clinical studies in gastrointestinal oncology for many years and completed a postdoctoral fellowship at the Scripps Clinic & Research Foundation in La Jolla, California. After receiving his M.D. degree, Dr. Löhr served a residency in pathology and a residency in internal medicine and gastroenterology in Erlangen and Rostock in Germany, where he also served as an Assistant Professor.

"It is my firm belief the Cell-in-a-Box® technology will prove to be of great value for the development of treatments for pancreatic and other cancers, and its possible role in a treatment for insulin-dependent diabetes is particularly intriguing. It is a pleasure to chair Nuvilex's Scientific Advisory Board. I look forward to working with the Nuvilex team to help bring this important technology to fruition," commented Dr. Löhr.

Dr. Löhr served as Principal Investigator for the Phase 1/2 and Phase 2 clinical trials of Nuvilex's pancreatic cancer treatment that were completed in the early 2000s. Not only is he familiar with the Cell-in-a-Box® live cell encapsulation technology that forms the core of Nuvilex's pancreatic cancer treatment, but he has actually used Nuvilex's treatment (the combination of Cell-in-a-Box® capsules with low doses of the anticancer drug ifosfamide) in clinical trials in patients with advanced, inoperable pancreatic cancer. Dr. Löhr previously agreed to serve as a consultant to Nuvilex in connection with its development of treatments for pancreatic cancer and diabetes based on the Cell-in-a-Box® technology. He has expertise in the treatment of both diseases in addition to thoroughly understanding the Cell-in-a-Box® technology and its use in a clinical setting.

Nuvilex's CEO and President, Kenneth L. Waggoner, commented, "We are extremely pleased that Dr. Löhr, one of Europe's leading gastroenterologists and oncologists, has agreed to serve as Chairman of our Scientific Advisory Board. Dr. Löhr's knowledge of the Cell-in-a-Box® technology and his experience in using Nuvilex's pancreatic cancer treatment in the clinic make him the ideal choice for this appointment. This belief is bolstered by the fact that Dr. Löhr is an expert in pancreatic cancer and has a keen interest and experience in the treatment of diabetes – both key areas of development for

SILVER SPRING, Md., Oct. 6, 2014 (GLOBE NEWSWIRE) -- Nuvilex, Inc. (OTCQB:NVLX), a clinical-stage biotechnology company providing cell therapy solutions for the treatment of diseases, announced today that noted European gastroenterologist and oncologist Dr. Matthias Löhr has agreed to serve as Chairman of Nuvilex's newly formed Scientific Advisory Board.

Dr. Löhr has been a full professor of gastroenterology and hepatology at the famed Karolinska Institute in Stockholm, Sweden, since 2007. He has served as Professor of Molecular Gastroenterology at the University of Heidelberg and was the Head of the Molecular Gastroenterology Unit at the German Cancer Research Center. Dr. Löhr has also worked as a translational scientist and Principal Investigator in clinical studies in gastrointestinal oncology for many years and completed a postdoctoral fellowship at the Scripps Clinic & Research Foundation in La Jolla, California. After receiving his M.D. degree, Dr. Löhr served a residency in pathology and a residency in internal medicine and gastroenterology in Erlangen and Rostock in Germany, where he also served as an Assistant Professor.

"It is my firm belief the Cell-in-a-Box® technology will prove to be of great value for the development of treatments for pancreatic and other cancers, and its possible role in a treatment for insulin-dependent diabetes is particularly intriguing. It is a pleasure to chair Nuvilex's Scientific Advisory Board. I look forward to working with the Nuvilex team to help bring this important technology to fruition," commented Dr. Löhr.

Dr. Löhr served as Principal Investigator for the Phase 1/2 and Phase 2 clinical trials of Nuvilex's pancreatic cancer treatment that were completed in the early 2000s. Not only is he familiar with the Cell-in-a-Box® live cell encapsulation technology that forms the core of Nuvilex's pancreatic cancer treatment, but he has actually used Nuvilex's treatment (the combination of Cell-in-a-Box® capsules with low doses of the anticancer drug ifosfamide) in clinical trials in patients with advanced, inoperable pancreatic cancer. Dr. Löhr previously agreed to serve as a consultant to Nuvilex in connection with its development of treatments for pancreatic cancer and diabetes based on the Cell-in-a-Box® technology. He has expertise in the treatment of both diseases in addition to thoroughly understanding the Cell-in-a-Box® technology and its use in a clinical setting.

Nuvilex's CEO and President, Kenneth L. Waggoner, commented, "We are extremely pleased that Dr. Löhr, one of Europe's leading gastroenterologists and oncologists, has agreed to serve as Chairman of our Scientific Advisory Board. Dr. Löhr's knowledge of the Cell-in-a-Box® technology and his experience in using Nuvilex's pancreatic cancer treatment in the clinic make him the ideal choice for this appointment. This belief is bolstered by the fact that Dr. Löhr is an expert in pancreatic cancer and has a keen interest and experience in the treatment of diabetes – both key areas of development for Nuvilex."

https://www.researchgate.net/profile/Matthias_Loehr

http://globenewswire.com/news-release/2014/10/06/670875/10101314/en/Nuvilex-Appoints-Dr-Matthias-Lohr-as-Chairman-of-Scientific-Advisory-Board.html#sthash.OOdSVnQh.dpuf

Dr Matthais Lohr, Dr Daniel Von Hoff, Dr Walter Gunzburg, Dr Brian Salmons, Dr Gerald Crabtree, Professor Ann Simpson, Dr Eva-Maria Brandtner, The Pancreatic Research Team, TD2, The Universty of Vienna, the Universty of Technology Sydney, University of Northern Colorado, Karolinska Institute, Thailand Science Park....

All are associated with and supporters of PharmaCyte Biotech who owns exclusive rights to Cell in a Box technology.

The business at hand.

SILVER SPRING, Md., March 16, 2015 (GLOBE NEWSWIRE) — PharmaCyte Biotech, Inc. (PMCB), a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box(R), today provided shareholders with an update on developments on progress in its cancer and diabetes programs and at the corporate level.
Kenneth L. Waggoner, Chief Executive Officer of PharmaCyte Biotech, stated, “Given all of the developments that have occurred since our last update, we believe it is an appropriate time to update our shareholders on developments and to highlight and briefly summarize what is in store for PharmaCyte Biotech in the coming days. Before doing so, however, we would like to address two issues that reportedly are of significant concern to a number of our shareholders. The first has to do with whether a reverse stock split is imminent. The second is whether we have access to capital to move forward with our clinical trials. PharmaCyte Biotech has no current plans to effectuate a reverse stock split. In addition, our cash position remains strong and our ability to raise capital continues to be very favorable.”
“As to the update, we remain focused on bringing our diverse platform technology to market and firmly believe our novel Cell-in-a-Box-based treatment will become a household name in the future. Our priority is and always has been to maximize shareholder value, and we are working diligently to reach that objective,” added Mr. Waggoner.
Progress in the Cancer Program
PharmaCyte Biotech’s treatment (Cell-in-a-Box(R) plus low-doses of ifosfamide) for advanced, inoperable pancreatic cancer was granted the Orphan Drug designation by the U.S. Food and Drug Administration (FDA) in late December of 2014.
On the basis of very positive results from our first preclinical study (4 groups of tumor bearing mice) that was conducted by Translational Drug Development (TD2) in the U.S. to determine the ability of the Cell-in-a-Box(R) plus low-doses of ifosfamide combination to delay the accumulation of malignant ascites fluid produced by abdominal cancers, an expanded study (12 groups of mice) is currently being conducted by TD2. This study is designed to elucidate parameters that will be needed for a future clinical trial that may result in the only treatment that can slow down the accumulation of malignant ascites fluid. It is expected that the study will be completed in the next 2 months. The target date for the initiation of the Phase 1 clinical trial in the U.S. is the third quarter of 2015.
Preparations for the Phase 2b clinical trial in patients with advanced, inoperable pancreatic cancer are ongoing. Major documents, including the Investigators Brochure and a clinical protocol (a recipe for conducting the clinical trial) are in preparation, with the assistance of Clinical Network Services (CNS) – one of Australia’s leading Clinical Research Organizations. The target date for the initiation of the Phase 2b clinical trial in Australia is the third quarter of 2015.
We initially reported that we expected to begin our Phase 2b clinical trial in the first quarter of 2015; however, we are awaiting the Good Manufacturing Practices (GMP) regulatory approval process that our partner, Austrianova, is currently involved with in order to get the GMP-compliant facility at the Thai Science Park in Bangkok, Thailand, approved to produce Cell-in-a-Box(R) capsules for human clinical trials. Austrianova believes the process will now be completed in the third quarter of 2015.
Progress is ongoing at the University of Northern Colorado in an attempt to identify a cell line that can be encapsulated using the Cell-in-a-Box(R) technology, which, in turn, can be used together with cannabinoid or cannabinoid-like prodrugs as a treatment for deadly cancers – such as brain and pancreatic cancer.
Progress in the Diabetes Program
Studies are in progress at the University of Veterinary Medicine, Vienna (UVM) to determine if Melligen (human, non-pancreatic, insulin-producing) cells are tumorigenic and to establish parameters by which these cells (human, non-pancreatic, insulin-producing) can produce and store insulin in response to glucose levels in their surroundings. The coordinator for these studies is Dr. Constantine Konstantoulas of UVM.
An exclusive license to use the Melligen cells developed by Prof. Ann Simpson of the University of Technology Sydney (UTS) in Australia has been obtained from UTS by PharmaCyte Biotech from UTS.
Dr. Eva-Maria Brandtner has been appointed Director of the Diabetes Research Program. Dr. Brandtner, presently at the Vorarlberg Institute for Vascular Investigation and Treatment (VIVIT) in Austria, was responsible for studies with the Melligen cells during her previous tenure with our partner, Austrianova, at its Chief Scientist.
Developments at the Corporate Level
The Company changed its name from Nuvilex, Inc. to PharmaCyte Biotech, Inc. to emphasize that it has fully transitioned from a nutraceutical company to a purely biotechnology company.
Changes have been and are being made at the Board of Directors level, with additional member candidates to the Board in their final interview process; these new members will be widely experienced in the life sciences.
Waggoner concluded, “We are pleased to offer this update to our shareholders. We trust that they will agree that significant progress is being made on all fronts.”

Very nice post, as usual, Bill... Enjoy your time as well...

This is the investment right here, Cell in a Box(R) technology.

http://www.pharmacytebiotech.com/pharmacyte-biotech-on-track-to-commence-clinical-trials/

http://www.pharmacytebiotech.com/live-cell-encapsulation/

http://www.mdpi.com/1999-4923/6/3/447

Yes, nice close and thank you... Happy Holidays Everyone!