pmcb

axelvento

dCellVax
Registrato
21/12/04
Messaggi
16.246
Punti reazioni
419
possiamo rientrare

ipervendutooooooooooooooo
 

Allegati

  • pmcb.png
    pmcb.png
    20,2 KB · Visite: 139

axelvento

dCellVax
Registrato
21/12/04
Messaggi
16.246
Punti reazioni
419
PharmaCyte Seeks to Solve Pancreas Puzzle with Cell-in-a-Box

Considering its relatively inconspicuous presence in the body, the pancreas can wreak havoc on human health through two major diseases: diabetes and pancreatic cancer. Both can be deadly – the former from the condition itself or from long-term complications and the latter from advanced disease that may be symptomatic for only months or even weeks. Neither has a cure.

Pharmacyte Biotech Inc. aspires to change that bleak prognosis with a technology that can attack both culprits. The Silver Spring, Md.-based company was founded in 1996 as Efood Systems, which tracked the movement of refrigerated trucks, before morphing into a natural products firm and eventually changing its name to Nuvilex Inc. In early 2011, the company established a relationship with the inventors of an unusual encapsulation technology with the idea of moving into nutraceuticals.

Poor financial decisions nearly derailed the company, which restructured again last year, assembling a new leadership team and taking direct aim at the biotech market with the live cell encapsulation platform, known as Cell-in-a-Box. Ken Waggoner, president, CEO and chairman of Pharmacyte, said the team “brought the technology back from the dead” and is eager to see the platform to fruition in multiple therapeutic applications.
Cell-in-a-Box technology involves the encapsulation of living cells in protective “cocoons” – capsules that are visible to the eye at about the size of the head of a pin. The capsules prevent the cells from escaping into the body while keeping the immune system from invading.

The multi-step encapsulation process begins with the suspension of the live cells in a medium that contains a polymer and sodium cellulose sulfate. That suspension is passed through specialized equipment to form droplets, which fall into a solution containing a second polymer. When the polymers interact, a membrane forms around each droplet, ultimately developing into the protective shell.

An important distinction between the capsules produced through Cell-in-a-Box technology and those fabricated by potential competitors is Pharmacyte’s use of cellulose – a bioinert material that doesn’t prompt an immune system response – rather than substances such as the seaweed derivative alginate or chitosan.

“The Cell-in-a-Box capsules can withstand various external forces, unlike those made using other encapsulation methods,” Waggoner said, enabling Pharmacyte’s capsules to be implanted intact using needles or catheters. “Our capsules don’t degrade, even after being present in the body for over two years, and they don’t cause damage to, or inflammation of, nearby tissues in the body.”

In the lead pancreatic cancer indication, approximately 300 Cell-in-a-Box capsules that each contain some 10,000 cytochrome P450-expressing cells are placed as close as possible to the tumor site, then one-third the normal dose of the chemotherapeutic ifosfamide is injected systemically. When the capsules and the chemotherapeutic come into contact, the encapsulated cells convert ifosfamide at the site of the tumor, providing a high concentration of the cancer-killing agent without the traditional side effects of high-dose chemotherapy.

Pharmacyte acquired exclusive global rights to the technology from Austrianova Singapore Pte. Ltd., of Singapore, in all cancer indications and in diabetes and also holds rights to use cancer prodrug-activating cells as part of the treatment protocol for advanced pancreatic and other cancers. The Cellin-a-Box capsules are produced in a cGMP-compliant facility managed by

Pharmacyte is preparing to conduct a phase IIb trial in patients with borderline operable or non-operable pancreatic cancer, expected to begin in the third quarter, that will compare its treatment head-to-head with gemcitabine combined with Abraxane (nab-paclitaxel, Celgene Corp.). In July, the company initiated a second preclinical study in mice to assess the effectiveness of its pancreatic cancer treatment on the rate of accumulation of malignant ascites fluid in pancreatic cancer and other abdominal tumors, testing four separate doses of ifosfamide with the goal of setting parameters for the design of a phase I. Pharmacyte plans to conduct a separate trial, also beginning this quarter, to investigate the role of Cell-in-the-Box in reducing pain associated with tumor growth.

Last year, the FDA granted orphan drug designation to the company’s pancreatic cancer treatment.
In addition to pancreatic cancer, data from an early trial suggested the Cell-in-a-Box technology might have an effect on downstream micro metastatic disease, which could apply to other tumor types. Pharmacyte has initiated preclinical programs in brain and breast cancer, using cannabinoid prodrugs in combination with Cell-in-a-Box. Last month, the University of Northern Colorado, one of the company’s research partners, obtained a Schedule 1 license from the Drug Enforcement Agency, enabling it to begin experiments using cannabinoids.

‘WE THINK WE HAVE A SHOT AT CURING DIABETES’

For treatment of type 1 and insulin-dependent type 2 diabetes, Pharmacyte uses the same Cell-in-a-Box technology but with Melligen cells – a human liver cell line genetically modified to produce insulin on demand that was developed by researchers at University of Technology Sydney, Australia – rather than the more common pancreatic beta-islet cells to serve as a bioartificial pancreas.

“A lot of companies are trying to do this type of technology with different types of cell encapsulation and different types of devices,” said Gerald Crabtree, Pharmacyte’s chief operating officer. “Nearly all of them are centered around some form of islet cell, but islet cells are notoriously difficult to keep alive for long periods in the body, even if they’re encapsulated.”

The Melligen cells “are easier to keep alive, and that’s the key,” he added. Pharmacyte holds the exclusive worldwide license to the cell line. Preclinical testing of the diabetes approach is under way through an international consortium the company recently spearheaded.

Although questions about the diabetes indication remain – exactly where to place the capsules in insulin-dependent patients, for instance – “we think we have a shot at curing diabetes,” Waggoner said. “We certainly know we can reverse the condition.”

Of course, the technology first needs to succeed in human studies, and that will take a few years.
“We believe we’ll be able to get into the clinic much sooner than anyone would have anticipated when we started down this path,” Waggoner said. Outside experts predicted the company would need more than five years to move the diabetes program, initiated in April 2014, into clinical trials, but Waggoner is confident that timetable can be truncated to 2017 – perhaps earlier. And, since the pancreatic cancer work is already under way, “by the time we get into the clinic with diabetes, the FDA will know this technology platform,” he pointed out.

In addition to establishing the diabetes consortium, Pharmacyte has been meeting with investors and clinical investigators and conducting road shows in New York, Boston and the Bay Area to “test drive” its message. The company also had a busy dance card at the BIO International Convention in Philadelphia, where it hosted dozens of meetings at its suite in the Ritz-Carlton Hotel.

For the time being, Pharmacyte is comfortably financed through a $50 million at-the-market facility. But with the prospect of large trials looming down the road, the company also is assessing the interest of big pharmas, and many have signed nondisclosure agreements.

“We’ve been approached by a number of people who want to get involved,” Waggoner said. “They’ve recognized that our treatment is very different from any approach that’s out there.”

Pharmacyte seeks to solve pancreas puzzle with Cell-in-a-Box | BioWorld
 

Allegati

  • pmcb.png
    pmcb.png
    19,4 KB · Visite: 102

playars

lotto players
Registrato
11/4/08
Messaggi
8.306
Punti reazioni
174
tanta roba$$$$$

$PMCB PharmaCyte Biotech Obtains Orphan Drug Designation in Europe for Its Pancreatic Cancer Treatment

Source: GlobeNewswire Inc.

PharmaCyte Biotech, Inc. (OTCQB: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®, announced today that, upon the recommendation of the European Medicines Agency (EMA), the European Commission has granted the Orphan Drug designation to PharmaCyte’s subsidiary, PharmaCyte Biotech Europe Limited, for PharmaCyte’s pancreatic cancer treatment. Receiving Orphan Drug designation for PharmaCyte’s pancreatic cancer treatment carries with it 10 years of marketing exclusivity in countries in the European Union. In addition, the EMA provides special assistance in the development of PharmaCyte’s treatment for pancreatic cancer.
The Orphan Drug designation in the European Union is given to drugs for life-threatening diseases with low prevalence, or that make it unlikely an investment in a drug to treat a life-threatening disease would be cost justified, and that demonstrate there is a significant benefit to patients being treated with the drug.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented on the significance of PharmaCyte obtaining the Orphan Drug designation, saying, “Obtaining Orphan Drug designation from the European Commission represents another significant milestone in the development of PharmaCyte’s pancreatic cancer treatment. This achievement is an exceedingly important one when coupled with the FDA’s granting of the same designation last year. It further facilitates the development of PharmaCyte’s pancreatic cancer treatment and once again serves to validate the Cell-in-a-Box® technology as a treatment for one of the most dreaded forms of cancer.”

PharmaCyte’s pancreatic cancer treatment consists of encapsulating genetically modified live cells capable of converting the anticancer prodrug ifosfamide into its cancer-killing form and placing the capsules as close to the cancerous tumor in the pancreas as possible. Then low doses of the inactive chemotherapy drug ifosfamide are given to the patient. When ifosfamide, which is carried by blood to where the capsules have been placed, comes in contact with the live cells, the drug is converted into its cancer killing form at the site of the disease rather than in the liver where conversion normally takes place. This technology enables high concentrations of the chemotherapeutic drug to be delivered directly to the cancer, without any treatment-related side effects like those normally associated with cancer chemotherapy.

PharmaCyte is preparing for a clinical trial designed to determine whether its pancreatic cancer treatment (Cell-in-a-Box® capsules + low-doses of ifosfamide) can satisfy a critical unmet medical need for patients with advanced pancreatic cancer when the gold standard of care, the combination of gemcitabine and Abraxane®, are no longer effective. The trial will be conducted in the United States with additional study sites in Europe and Australia.

About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This unique and patented technology will be used as a platform upon which treatments for several types of cancer and diabetes are being developed.

PharmaCyte’s treatment for cancer involves encapsulating genetically modified live cells capable of converting an inactive chemotherapy drug (ifosfamide) into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, ifosfamide is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the drug takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.

In addition to developing a novel treatment for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and secrete insulin at levels in proportion to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology.

Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate," "believe," "estimate," "expect," "intend," "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.

More information about PharmaCyte can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.


Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Primary Logo
 

Italia77

Nuovo Utente
Registrato
11/4/09
Messaggi
3.734
Punti reazioni
158
il minimo del 26/10 vedo che fu 7 cents e ora siamo a 8 circa...
valuto un po' in these days se mettere cippino..
adesso me la studio, non so manco cosa faccia questa società,
magari ha ancora più potenziale di regen,
grazie per la segnalazione!

O/S -> 743 M
A/S -> 1,5 B
ad oggi vale 65M$ l'azienda
lo short selling report parla di alte %
quindi a breve possibile ricopertura forse :cool:

In ripida discesa, forse a 0,08 entrata possibile :censored:
PMCB - SharpCharts Workbench - StockCharts.com
 
Ultima modifica:

axelvento

dCellVax
Registrato
21/12/04
Messaggi
16.246
Punti reazioni
419
questa è un altra chicca$$$$$$$$$$$$$$$$$$$
 

axelvento

dCellVax
Registrato
21/12/04
Messaggi
16.246
Punti reazioni
419
che prezzi sono arrivati i saldi$$$$$ alert:eek::eek::eek:


PharmaCyte Biotech, Inc. (OTCQB: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®, announced today the Company’s 2016 milestones as it advances its new treatment for pancreatic cancer into the clinic in the United States with study sites in Europe and Australia.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, stated, “We are excited to see 2016 arrive as this is the year that we will get into the clinic with our pancreatic cancer treatment. Our shareholders should understand that nothing whatsoever will deter our efforts to get into the clinic and to showcase our novel treatment for pancreatic cancer.”

Waggoner highlighted the 2016 milestones that PharmaCyte’s shareholders and investment community can look forward to this year:

PharmaCyte’s CEO will attend the 2016 JP Morgan Healthcare conference in San Francisco to meet with pharmaceutical companies and potential institutional investors.

The manufacturing facility in Bangkok, Thailand, where the live cells that convert the cancer prodrug ifosfamide into its cancer-killing form will be encapsulated, will receive a factory license from the Thai government enabling production of the encapsulated cells for PharmaCyte to use in its clinical trials.

The Austrianova manufacturing facility will become fully compliant with current Good Manufacturing Practices (cGMP) standards.

An Investigational New Drug Application (IND) will be filed with the FDA following a pre-IND meeting with the FDA.

Appropriate arrangements will be made with cancer centers in the United States to begin PharmaCyte’s pancreatic cancer trial that will address the critical unmet medical need that exists when a patient’s non-metastatic, pancreatic cancer no longer benefits from receiving the “gold standard” treatment – the combination of gemcitabine and Abraxane®.

PharmaCyte’s clinical trial in pancreatic cancer will get underway with Translational Drug Development (TD2) coordinating the trial globally and conducting it in the United States. Clinical Network Services (CNS) will conduct the trial in Europe and Australia in alliance with TD2.

After the pancreatic cancer clinical trial has been in process for approximately six months, there will be an evaluation of PharmaCyte’s pancreatic cancer treatment on the patients enrolled in the trial with the interim results being reported to the public.

Additional preclinical studies to determine if PharmaCyte’s pancreatic cancer treatment can slow down the production and accumulation of malignant ascites fluid will take place in 2016. If successful, plans to conduct a clinical trial in ascites will be undertaken by PharmaCyte with the goal of having TD2 begin the clinical trial by year end or early 2017.

Numerous preclinical studies will be conducted concurrently and in parallel by members of PharmaCyte’s international Diabetes Consortium to condense the time it will take for PharmaCyte to enter into a clinical trial that will test the ability of the Melligen insulin-producing cells encapsulated using the Cell-in-a-Box® technology to treat Type 1 diabetes and insulin-dependent Type 2 diabetes, with the goal of reaching the clinic in 2017.

PharmaCyte will fill its open Board of Directors positions as appropriate.

PharmaCyte will conduct periodic shareholder calls, rather than communicating through shareholder updates, with the CEO responding to questions during the calls.

PharmaCyte will hold an annual shareholder meeting.

PharmaCyte’s Chief Operating Officer, Dr. Gerald W. Crabtree stated, “2016 promises to be both busy and productive for the Company and those associated with it. Of course the major highlight will be the start of our clinical trial in pancreatic cancer.

About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This unique and patented technology will be used as a platform upon which treatments for several types of cancer and diabetes are being developed. PharmaCyte’s treatment for cancer involves encapsulating genetically modified live cells that convert an inactive chemotherapy drug (ifosfamide) into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, ifosfamide is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the drug takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.

In addition to developing a novel treatment for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology.

Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate," "believe," "estimate," "expect," "intend," "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.

More information about PharmaCyte can be found at PharmaCyte Biotech - Home of Biotechnology. It can also be obtained by contacting Investor Relations.


Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
 

Allegati

  • pmcb.png
    pmcb.png
    18,6 KB · Visite: 63

axelvento

dCellVax
Registrato
21/12/04
Messaggi
16.246
Punti reazioni
419
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®, announced today the Company’s Chief Executive Officer, Kenneth L. Waggoner, will attend the 34th Annual J.P. Morgan Healthcare Conference in San Francisco, California, from January 10-15, 2016. PharmaCyte has a full schedule of meetings in which the CEO will present and update PharmaCyte’s platform technology in the treatment of pancreatic cancer and diabetes to potential institutional investors, pharmaceutical companies, and the life science media.

The J.P. Morgan Healthcare Conference brings together corporate leaders, financial sponsors and institutional investors to explore markets and sector trends. The annual J.P. Morgan Healthcare Conference is a signature showcase event for these important stakeholders to facilitate success in the area of healthcare around the globe. This week PharmaCyte released a list of its milestones for 2016, which included next week’s J.P. Morgan Healthcare Conference. Shareholders and the investment community can read the complete list of milestones here: PharmaCyte Biotech Outlines 2016 Milestones as Its Pancreatic Cancer Treatment Moves Into a Clinical Trial - PharmaCyte Biotech, Inc..

PharmaCyte’s pancreatic cancer treatment consists of encapsulating genetically modified live cells that convert the anticancer prodrug ifosfamide into its cancer-killing form and placing those capsules as close to the tumor in the pancreas as possible. Low doses of the inactive chemotherapy drug ifosfamide are then given to the patient. When the ifosfamide, which is carried by blood to where the capsules have been placed, comes in contact with the live cells, the drug is converted into its cancer killing form at the site of the cancer rather than in the liver where conversion normally takes place. This technology enables high concentrations of the chemotherapeutic drug to be delivered to the source of the cancer and directly targets the cancer without any treatment-related side effects like those normally associated with cancer chemotherapy.

PharmaCyte is preparing for its pancreatic cancer clinical trial in the United States with study sites in Europe and Australia. The trial will address the critical unmet medical need that exists when a patient’s non-metastatic, pancreatic cancer no longer benefits from receiving the “gold standard” treatment – the combination of gemcitabine and Abraxane®. Translational Drug Development (TD2) will be coordinating the trial globally, and TD2 will be conducting the trial in the United States. Clinical Network Services (CNS) will be conducting the trial in Europe and Australia in alliance with TD2.

About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company focused on developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This unique and patented technology will be used as a platform upon which treatments for several types of cancer and diabetes are being developed.

PharmaCyte’s treatment for cancer involves encapsulating genetically modified live cells that convert an inactive chemotherapy drug (ifosfamide) into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, ifosfamide is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.

In addition to developing a novel treatment for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology.

Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate," "believe," "estimate," "expect," "intend," "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.

More information about PharmaCyte can be found at PharmaCyte Biotech - Home of Biotechnology. It can also be obtained by contacting Investor Relations.

Contact:

Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
 

axelvento

dCellVax
Registrato
21/12/04
Messaggi
16.246
Punti reazioni
419
sono dentro con l'intero bottino



PharmaCyte Biotech, Inc. (OTCQB:PMCB), a clinical stage biotechnology company focused on developing targeted therapies for cancer and diabetes using its live-cell encapsulation technology, Cell-in-a-Box®, presents today another in a series of articles that will serve to educate the public on its live-cell encapsulation technology and its use in developing treatments for pancreatic cancer and diabetes. This educational piece addresses PharmaCyte’s intellectual property (IP) and the strategy that PharmaCyte will employ to protect that property.
PharmaCyte’s IP consists of exclusive license agreements that PharmaCyte has with other parties and IP that PharmaCyte intends to create during the clinical development of its product candidates. In the questions and answers below, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, discusses PharmaCyte’s IP protection strategy, which consists of patents, patent term extensions, regulatory data exclusivity, market exclusivity for orphan drugs, know-how/trade secrets and trademarks.

PharmaCyte’s Intellectual Property Protection Strategy

Which family of patents protects PharmaCyte’s pancreatic cancer therapy and what is your plan to extend those patents?

“Before I answer that question, let me say that our pancreatic cancer therapy has two iron-clad protections that will far surpass any protection that our patents could ever bring if we can obtain FDA approval. I will discuss this a little later in this piece, but keep in mind while reading these responses that our pancreatic cancer therapy is going to remain protected long after the patents expire.

“Everyone interested in PharmaCyte’s pancreatic cancer therapy should be focused on the family of patents that deal with the live-cell encapsulation of genetically altered human cells that overexpress a form of the Cytochrome p450 enzyme system (normally found in the liver), and specifically on only 2 patents in that family. Those patents are set to expire in the United States a little over a year from now on March 27, 2017. These are the only patents that pertain to PharmaCyte’s pancreatic cancer therapy. Now, while these patents are set to expire next year, we certainly aren’t sitting idly by and allowing that to happen.

“We do have a protection strategy in place, which includes filing an application with the U.S. Patent and Trademark Office for interim extensions extending the life of those patents 1 year at a time for up to 5 years, which we believe will be long enough to get us through clinical trials and the regulatory approval process. The earliest the application can be filed is 6 months before the expiration of the patents, and the application can be filed up to 15 days before the expiration date. PharmaCyte can and plans to file its patent extension application between September 27, 2016, and March 12, 2017.”

Can PharmaCyte apply for follow-on patents? If so, can you explain what these patents are?

“Yes. New patentable inventions related to a pharmaceutical product, also called ‘follow-on patents,’ generally encompass improvements to, or new uses for, the pharmaceutical not disclosed or suggested in the original patent. PharmaCyte anticipates extending its patent protection for its product candidates through improvements to its core technology, including:

1. New Formulations: New formulations of a known drug compound that are clinically superior to the previous drug formulation may be patentable. Developing new formulations that promote a patient’s successful therapy through such things as reduced dosing or ease of use, or that exhibit improved therapeutic outcomes or more favorable side-effect profiles, are patentable. Examples include sustained-release formulations, extended-release formulations and dosing regimens.

2. New Routes of Administration: Additional patent protection may be obtained for new formulations that permit new routes of administration.

3. New Uses: Patents directed to new uses and treatments may be obtained.

4. Combinations: Combining two or more drugs into one treatment also may be patentable.

New discoveries that may be eligible for patent protection as follow-on patents cannot be predicted at the current time; however, PharmaCyte anticipates improvements to its technology and product candidates to be generated as these product candidates move through clinical testing.”

Being that PharmaCyte’s cancer product candidates are biologics, does PharmaCyte qualify for regulatory data protection and the 12 years of data exclusivity that comes with it as outlined by the Biologics Price Competition and Innovation Act (BPCIA), which was enacted as part of the Affordable Care Act in 2010?

“Yes. This is one of the two iron-clad protections that I was speaking of earlier in this article. We will be seeking this protection and the 12 years of data exclusivity it provides. ‘Reference product exclusivity’ or ‘regulatory data protection’ is an IP right available for a limited duration, which protects an innovator's proprietary safety and efficacy data for its innovative product. This protection prevents any other party, during an exclusivity term of 12 years, from relying on the innovator's proprietary data in order to obtain marketing approval or authorizations for a follow-on ‘biosimilar’ or generic drug product. A biosimilar product is a follow-on version of an innovator’s biological product.

“PharmaCyte’s cancer product candidates are considered biological products because the capsules that are part of those products contain living, albeit genetically altered, human cells. Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues and recombinant therapeutic proteins. The BPCIA created an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.

“The BPCIA establishes a period of 12 years of data exclusivity for reference products in order to preserve incentives for future innovation. Under this framework, data exclusivity protects the data in the innovator’s regulatory application by prohibiting others, for a period of 12 years, from gaining FDA approval based in part on reliance on or reference to the innovator’s data in their biosimilar application. PharmaCyte anticipates its 12-year exclusivity will begin as soon as the FDA approves its pancreatic cancer product candidate.

“Countries in the European Union (EU) also provide for such data protection. Further, in October 2015 it was agreed as part of the Trans-Pacific Partnership trade deal between the United States, Australia, Brunei, Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam that biologic drugs will be given a minimum of 5 years data exclusivity.”

Can you explain how the Orphan Drug designation that PharmaCyte has received in both the United States and in the European Union is a major source of protection for PharmaCyte’s pancreatic cancer therapy?

“This is the second of the two protections I spoke of earlier. PharmaCyte’s pancreatic cancer product candidate was designated an orphan drug and listed in the official registry of medicinal products for rare diseases by the FDA on December 17, 2014. This orphan drug status assures market exclusivity for PharmaCyte in the United States for 7 years after market approval. Similarly, PharmaCyte has orphan drug status in the EU for its pancreatic cancer product candidate. This designation provides 10 years of market exclusivity in all of the countries in the EU and assistance from the EMA in the product development.

“So it should be understood that once we gain market approval, our pancreatic cancer therapy will have exclusive protections with both the regulatory data protection and the orphan drug designations. In addition, there are a number of know-how/trade secrets and trademark protections built in that we believe will make it exceedingly difficult for any company or entity to ever duplicate our pancreatic cancer therapy and complete clinical trials before we reach market approval. Conservative estimates have indicated that, given the complex nature of the trade secrets/know-how associated with our IP portfolio, we may be able to extend the protection of our IP portfolio by at least several years on this basis alone.”

In addition to PharmaCyte’s pancreatic cancer therapy, PharmaCyte also has a diabetes therapy that it is developing that will need protecting. Can you discuss how you’ll protect the therapy that consists of Cell-in-a-Box® and Melligen cells?

“PharmaCyte has a License Agreement with the University of Technology Sydney (UTS) in Australia that provides PharmaCyte with an exclusive worldwide right to use genetically modified human liver cells called ‘Melligen cells.’ Those cells have been modified to contain pancreatic islet cell glucokinase for use in developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. The Melligen cells are protected by a patent issued in the EU that is in the process of being validated in each of the major countries. In addition, there is a patent pending in the United States. The License Agreement also provides PharmaCyte with the non-exclusive worldwide rights to ‘know-how’ associated with the Melligen cells.

“PharmaCyte also licensed from Austrianova the exclusive, worldwide rights to use the Cell-in-a-Box® cellulose-based live-cell encapsulation technology for the development of a treatment for diabetes and the use of Austrianova’s Cell-in-a-Box® trademark for this technology. The diabetes Licensing Agreement grants PharmaCyte exclusive worldwide rights to use the Cell-in-a-Box® technology with genetically modified or non-modified non-stem cell lines, designed to produce insulin and/or other critical components for the treatment of diabetes.”

In simple terms, how would you summarize PharmaCyte’s strategy for protecting its IP portfolio?

“PharmaCyte has several diverse avenues available to it for protecting its IP portfolio. We plan to pursue all of these in order to extend our IP portfolio to the greatest extent possible.”
 

axelvento

dCellVax
Registrato
21/12/04
Messaggi
16.246
Punti reazioni
419
PharmaCyte Biotech, Inc. (OTCQB: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®, today announced that it has appointed Dr. Sanjay Batra as its Senior Business Development Advisor.
Dr. Sanjay Batra brings to PharmaCyte more than 20 years of global healthcare and entrepreneurial experience in start-ups, biotech and large pharma. Dr. Batra spent 10 years at Johnson & Johnson, culminating as Vice President, R&D Pharmaceuticals, Asia-Pacific and Japan. He is highly skilled in partnering with diverse stakeholders, such pharmaceutical companies, the investment community, academia and key opinion leaders. In addition, Dr. Batra has been involved in over 80 clinical trials in all phases of development and commercialization.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of Dr. Batra’s appointment, “We are pleased that Dr. Batra has agreed to join our team, as we now have a cGMP-compliant facility and are ready to enter into the next phase of our life-cycle as a biotech company. We believe that his experience at Johnson & Johnson and his global network will prove invaluable to PharmaCyte. His expertise in scientific, medical and business areas, both domestically and internationally, will be a key asset as we move PharmaCyte forward towards the successful development of our novel platform technology to treat pancreatic cancer and diabetes.”

Dr. Batra said, “I am very excited to be part of the PharmaCyte team at this pivotal time. The technology holds tremendous promise to help physicians and their patients in areas of significant unmet medical need. Mr. Waggoner has built a very solid organization, and I look forward to making contributions with pace and rigor to advance our product pipeline towards commercialization.”

Most recently, Dr. Batra served as President and CEO of Aesthetic Factors, an emerging company providing autologous, point-of-care therapies in Regenerative Medicine. In this role, Dr. Batra led the commercial growth of their platelet-rich plasma and autologous fat products and was instrumental in establishing the company as the science driven leader. In 2013, Dr. Batra founded VIAS Partners with the aspiration to take his diverse experiences and global network to partner with entrepreneurs and companies to advance their business concepts.

Dr. Batra obtained his Ph.D. in medical physiology from the University of Ottawa, Canada, and completed his post-doctoral training with world-renowned scientists in Japan and Switzerland. He is a Fellow of the American College of Cardiology and an Adjunct Professor at the Wake Forest Institute for Regenerative Medicine. Dr. Batra has published over 50 papers and 70 abstracts, and has made more than 100 invited scientific presentations.

About PharmaCyte Biotech
PharmaCyte Biotech is a clinical stage biotechnology company developing and preparing to commercialize treatments for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which treatments for several types of cancer and diabetes are being developed. PharmaCyte’s treatment for cancer involves encapsulating genetically modified live cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated live cells are placed as close to a cancerous tumor as possible. Once implanted in a patient, a chemotherapy drug which needs to be activated in the body (ifosfamide) is then given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been placed. When the ifosfamide, which is normally activated in the liver, comes in contact with the encapsulated live cells, activation of the chemotherapy drug takes place at the source of the cancer without any side effects from the chemotherapy. This “targeted chemotherapy” has proven remarkably effective and safe to use in past clinical trials.

In addition to developing a novel treatment for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and Type 2 insulin-dependent diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology.

Safe Harbor
This press release may contain forward-looking statements regarding PharmaCyte Biotech and its future events and results that involve inherent risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend", "plan" and similar expressions, as they relate to PharmaCyte or its management, are intended to identify forward-looking statements. Important factors, many of which are beyond the control of PharmaCyte, could cause actual results to differ materially from those set forth in the forward-looking statements. They include PharmaCyte's ability to continue as a going concern, delays or unsuccessful results in preclinical and clinical trials, flaws or defects regarding its product candidates, changes in relevant legislation or regulatory requirements, uncertainty of protection of PharmaCyte’s intellectual property and PharmaCyte’s continued ability to raise capital. PharmaCyte does not assume any obligation to update any of these forward-looking statements.

More information about PharmaCyte Biotech can be found at www.PharmaCyte.com. It can also be obtained by contacting Investor Relations.

Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com
 

axelvento

dCellVax
Registrato
21/12/04
Messaggi
16.246
Punti reazioni
419
www.PharmaCyte.com/diabetes.

NEW YORK, NY--(Marketwired - July 19, 2016) - Worldwide the number of people living with diabetes has reached 422 million, and if the current trend continues, over 700 million people are expected to be living with diabetes by 2025. Diabetes has clearly become a healthcare crisis on a global scale, and PharmaCyte Biotech (OTCQB: PMCB) recently received some good news in the form of patent protection that will help the company do its part in bringing a treatment to tens of millions of these patients.

PharmaCyte recently learned from the U.S. Patent and Trademark Office (USTPO) that it now has 20 years of patent protection in the United States for the "Melligen" cells that are a part of the company's therapy for Type 1 and insulin-dependent Type 2 diabetes. The timing is perfect because the same research that laid out the dramatic rise in the numbers of people affected by diabetes, also found that the global cost of diabetes has ballooned to $825-billion per year.

These staggering numbers come from the largest study ever done on diabetes levels across the globe. The study was published in the journal The Lancet and was led by scientists from Imperial College London, and involved Harvard T.H. Chan School of Public Health, the World Health Organization, and nearly 500 researchers across the globe, and it incorporated data from 4.4 million adults in most of the world's countries.

PharmaCyte's therapy for diabetes is made up of its signature live-cell encapsulation technology Cell-in-a-Box®, which are pinhead-sized, porous capsules that are filled with insulin producing cells (Melligen cells). The capsules would protect the Melligen cells from destruction by the immune system and, in turn, would essentially create an "artificial pancreas" for type 1 diabetics and insulin-dependent type 2 diabetics that no longer produce their own insulin.

Prof. Ann. M Simpson and her colleagues at the University of Technology Sydney developed the Melligen cell line as an alternative to the transplantation of islets. According to Prof. Simpson and her team's research, which was published in the journal, Molecular Therapy -- Methods & Clinical Development, the cells are a human liver cell line that has been genetically engineered to reverse type 1 diabetes. (http://www.nature.com/articles/mtm201511)

The authors of the article note that, for the Melligen cells to be effective in treating Type 1 diabetes in humans where the insulin-producing β cells of the pancreas have been destroyed, it will be necessary to protect those cells from rejection by the body's immune system after they have been introduced into the body. The article points out that one way to protect the Melligen cells would be to encapsulate the cells in protective "cocoons" prior to being placed into a diabetic patient. If this is done, the authors believe that encapsulated Melligen cells may offer a "cure" for Type 1 diabetes.

It was PharmaCyte's Cell-in-a-Box® that got the attention of Prof. Simpson and her colleagues as the ideal encapsulation technology. In a 6-month study, pancreatic islet cells from pigs were encapsulated using the Cell-in-a-Box® capsules. Those capsules containing the islet cells were then implanted into live, diabetic rats. Within only a few days, the blood-sugar levels of the diabetic rats became normal and stayed at normal levels for the entire study.

When the capsules were removed from the rats at the end of the study, the islet cells inside the capsules were still alive and functioning. Pigs were chosen as the source for the pancreatic islet cells because biologically they are the closest to humans. Because islet cells from pigs ("foreign" donors) could be implanted in rats without the cells being rejected, this proves the islet cells inside PharmaCyte's Cell-in-a-Box® capsules were protected from attack by the rats' immune systems.

So now that the Melligen cells have received the patent protection necessary in both the United States and Europe, the marriage between the Cell-in-a-Box® capsules and the Melligen cells is in the hands of PharmaCyte's International Diabetes Consortium, which consists of world-renowned physicians and scientists from a number of countries around the world, all of whom share the same goal of developing a treatment for insulin-dependent diabetes.

Watch PharmaCyte's video on the development of its diabetes treatment at: www.PharmaCyte.com/diabetes.

About Stock Market Media Group

Stock Market Media Group is a Content Development IR firm offering a platform for corporate stories to unfold in the media with research reports, corporate videos, CEO interviews and feature news articles. This article was written based upon publicly available information. PharmaCyte Biotech has not endorsed this article, and Stock Market Media Group was not compensated for its production.
 

axelvento

dCellVax
Registrato
21/12/04
Messaggi
16.246
Punti reazioni
419
LAGUNA HILLS, Calif., Nov. 01, 2016 (GLOBE NEWSWIRE) -- PharmaCyte Biotech, Inc. (OTCQB: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®, today announced that it has submitted a request for a pre-IND meeting with the U. S. Food and Drug Administration (FDA) for its planned clinical trial in locally advanced, inoperable pancreatic cancer (LAPC).

PharmaCyte has submitted questions to the FDA as part of a pre-IND meeting request where aspects of the content of the Investigational New Drug (IND) application itself (CMC section, clinical trial description, etc.) will be discussed. After the FDA has responded to the questions and issued comments, PharmaCyte must address them to the FDA's satisfaction. A review of PharmaCyte’s responses by the FDA will then take place at the formal pre-IND meeting where final agreement between PharmaCyte and the FDA on all aspects discussed will be reached. With this information, the IND will be submitted by PharmaCyte and reviewed by the FDA. Once the IND is found to be acceptable to the FDA, patients can be enrolled in PharmaCyte’s clinical trial.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the meeting request, "We are pleased that PharmaCyte has taken the first step towards regulatory approval in the United States of its therapy for LAPC. When I started to lead this company in January 2014, my first goal was to surround our technology with the best of the best in the biotech sector. I believe we have more than accomplished this goal as we have compiled an internationally renowned team that will lead PharmaCyte into what we expect to be a pivotal human clinical trial. My second goal was to get our therapy to the FDA, and with this pre-IND meeting request, we have accomplished this goal as well. My ultimate goal, of course, was and is to get our pancreatic cancer therapy into clinical trials and approved by the FDA. I feel we are well on our way to accomplishing this goal.”

PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they become operable.

About PharmaCyte Biotech

PharmaCyte Biotech a clinical stage biotechnology company developing therapies for cancer and diabetes based upon a proprietary cellulose-based live cell encapsulation technology known as “Cell-in-a-Box®.” This technology will be used as a platform upon which therapies for several types of cancer and diabetes are being developed. PharmaCyte’s therapy for cancer involves encapsulating genetically engineered human cells that convert an inactive chemotherapy drug into its active or “cancer-killing” form. These encapsulated cells are implanted as close to the patient’s cancerous tumor as possible. Once implanted, a chemotherapy drug that is normally activated in the liver (ifosfamide) is given intravenously at one-third the normal dose. The ifosfamide is carried by the circulatory system to where the encapsulated cells have been implanted. When the ifosfamide comes in contact with the encapsulated cells they act as an artificial liver and activate the chemotherapy drug at the source of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in no side effects.

In addition to developing a novel therapy for cancer, PharmaCyte is developing a treatment for Type 1 diabetes and insulin-dependent Type 2 diabetes. PharmaCyte plans to encapsulate a human cell line that has been genetically engineered to produce, store and release insulin in response to the levels of blood sugar in the human body. The encapsulation will be done using the Cell-in-a-Box® technology. Once the encapsulated cells are implanted in a diabetic patient they will function as a “bio-artificial pancreas” for purposes of insulin production.



______________________________________________________________________

PharmaCyte’s clinical trial in patients with LAPC is designed to meet a clear unmet medical need for those whose cancer no longer responds after 4-6 months of treatment with the combination of Abraxane® plus gemcitabine. The trial will be open-label and multi-site in nature, with sites in the U.S. and Europe. Patients with LAPC will be randomized equally into two groups. One group will receive gemcitabine chemotherapy alone, and the other group will receive PharmaCyte’s pancreatic cancer therapy (encapsulated genetically modified live human cells that can activate the cancer prodrug ifosfamide plus low doses of the prodrug to eliminate side effects from the chemotherapy). In addition to comparing the anticancer activity and safety of the two therapies, a major aspect of the trial will be to determine if, and how well, PharmaCyte’s therapy can shrink inoperable tumors so that they become operable.


2 cure separate chemio Live Cell Encapsulation Technology - PharmaCyte Biotech, Inc.
una grande scommessa$$$$$$$$$$$$