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PharmaCyte Biotech (PMCB) Closer to Submitting IND by Successfully Completing Encapsulation of Second Manufacturing Run of Clinical Trial Product

Joe Samuel

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LAGUNA HILLS, Calif.–(BUSINESS WIRE)– PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, is closer to submitting an Investigational New Drug application (IND) to the U.S. Food & Drug Administration (FDA). PharmaCyte announced today that its partner, Austrianova Singapore (Austrianova), has successfully completed encapsulation of the cells from PharmaCyte’s Master Cell Bank (MCB) in the second of two staggered and back-to-back manufacturing runs for the production of PharmaCyte’s clinical trial product. This product will be used for PharmaCyte’s planned clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC).

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “The encapsulation process was performed last week at Austrianova’s manufacturing facility in Thailand. After reviewing the first pictures of the encapsulated cells, we’re confident that this manufacturing run is progressing as well as our first successful manufacturing run.

“We are anxiously awaiting the completion of the second of the two back-to-back manufacturing runs and the results from the FDA required testing on each of those runs. Once the information from that testing is available, it will be incorporated into our Investigational New Drug application (IND) for submission to the FDA.”

Most of the work needed for PharmaCyte to submit an IND to the FDA has been completed. The rate limiting factor is and always has been for Austrianova to complete successfully two back-to-back manufacturing runs. During PharmaCyte’s recent shareholder update call, the company reported on Austrianova’s work to encapsulate successfully PharmaCyte’s genetically modified human cells that will be used to treat patients suffering from LAPC.

After months of extensive research and development (R&D) by a team of experts from Austrianova and PharmaCyte, a total of eight different changes were made to the manufacturing process. It was not until the eighth and final change was made that the encapsulated cells grew as well in Austrianova’s manufacturing facility in Thailand as they grew at Austrianova’s R&D facility in Singapore.

Once the recently encapsulated cells in this second of two manufacturing runs have completely filled the capsules, they will be placed into PharmaCyte’s clinical trial syringes and then frozen. A representative sample of those syringes will be thawed and undergo the FDA required “release testing.” All “release testing” related to safety of the encapsulated cells is being outsourced by PharmaCyte to independent third-party laboratories in Europe. All “release testing” related to functionality of the encapsulated cells is being handled by Austrianova at its GMP facility in Thailand.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, the company encourages you to watch its documentary video complete with medical animations at: https://www.PharmaCyte.com/Cancer

About PharmaCyte Biotech

PharmaCyte Biotech, Inc. (PharmaCyte) is a biotechnology company developing cellular 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. For pancreatic cancer, these encapsulated cells are implanted in the blood supply to the patient’s tumor as close as possible to the site of the tumor. 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 flows through pores in the capsules, the live cells inside act as a “bio-artificial liver” and activate the chemotherapy drug at the site of the cancer. This “targeted chemotherapy” has proven effective and safe to use in past clinical trials and results in little to no treatment related side effects.

PharmaCyte’s therapy for Type 1 diabetes and insulin-dependent Type 2 diabetes involves encapsulating a human cell line that has been genetically engineered to produce and release insulin in response to the levels of blood sugar in the human body. PharmaCyte is developing the use of genetically modified liver cells and stem cells, as well as beta islet cells, to treat diabetes. 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.

Safe Harbor

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of the management of PharmaCyte, including statements regarding the timing and commencement of our first Phase 2b clinical trial. Any statements contained herein that do not describe historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results, performance and achievements to differ materially from those discussed in such forward-looking statements. Factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.

More information about PharmaCyte can be found at www.PharmaCyte.com. Information may also be obtained by contacting PharmaCyte’s Investor Relations Department.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191104005282/en/

Dr. Gerald W. Crabtree
Investor Relations:
PharmaCyte Biotech, Inc.
Investor Relations Department
Telephone: 917.595.2856
Email: Info@PharmaCyte.com

Source: PharmaCyte Biotech, Inc.

Disclaimer: Pursuant to an agreement between MIDAM VENTURES, LLC and Complete Investment And Management LLC, a Non-affiliate Third Party, Midam was hired for a period from 07/09/2019 – 8/09/2019 to publicly disseminate information about PharmaCyte Biotech including on the Website and other media including Facebook and Twitter. We were paid $150,000 (CASH) for & were paid “0” shares of restricted common shares. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 8/12/2019 – 10/15/2019. We were paid an additional $150,000 (CASH) BY Complete Investment And Management LLC, a Non-affiliate Third Party, AND HAVE EXTENDED coverage for a period from 10/16/2019 – 11/15/2019.We may buy or sell additional shares of PharmaCyte Biotech in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information. Click here for full disclaimer.

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Biotechnology

2 Biotech Stocks Turning Heads After Key Developments This Quarter

Joe Samuel

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biotech stocks to watch today

There are very few sectors in the stock market that have consistently produced winning trades. You might be able to count such sectors on one hand. Biotech is certainly among those sectors due to the emergence of highly innovative companies. These firms tend to create new avenues of creation to address unmet medical needs.

There are plenty of promising companies in the sector but it is necessary for an investor to do research thoroughly. It makes finding the best biotech stocks a bit easier. Though no one’s guaranteed a win, sifting out bad stocks is the key. One must watch the market closely to come across promising biotech stocks. Here is a look at two biotech stocks that are worth watching.

Biotech Stocks To Watch: Moleculin Biotech (MBRX)

The first biotech stock to consider is that of Moleculin Biotech Inc (NASDAQ:MBRX), which made some gains on Wednesday on the back of positive interim results for one of its products. The company, which is involved in manufacturing medicines meant for extremely resistant tumors, released data with regards to its acute myeloid leukaemia medicine annamycin.

top biotech stocks to buy

Moleculin revealed highly positive interim data from the Phase ½ clinical study of the medicine and naturally, it has resulted in a lot of excitement in the market with regards to the stock. The stock rose by as much as 2% on the back of the news in yesterday’s trading session. It is one of the key biotech stocks to keep an eye on over the coming days.

Biotech Stocks To Watch: Eyepoint Pharmaceuticals (EYPT)

The other biotech stock that has recorded impressive gains on the market today is the Eyepoint Pharmaceuticals Inc (NASDAQ:EYPT) stock. On Wednesday, the company announced an important deal with regard to dexamethasone intraocular suspension 9% (DEXYCU). Eyepoint announced that it has managed to reach an agreement with one of the biggest players in the U.S. integrated delivery systems.

[Read More] 3 Pharma Stocks To Watch In December 2019

The deal is for two years and the other party is going to offer DEXYCU in its aforesaid systems. It is a major boost for Eyepoint and it has resulted in 5% to close at $1.54 in Wednesday’s trading session.

best biotech stocks to watch today

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Stock Price Newsletter – December 6, 2019

Joe Samuel

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stock price newsletter

2 Biotech Stocks to Watch As The Sector Hits New High

The biotech sector has thrown plenty of winners over the course of the last decade or so and if experts are to be believed then it is going to continued to do so for the foreseeable future. Great advancements are being made in the biotech industry and many companies are working on a highly advanced product.

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Is It Time To Buy Or Sell Netflix; Streaming Wars Heat Up

The streaming wars have commenced this month with the launch of Disney Plus and Apple TV+. Many more services are going to be launched over the coming months and the sole purpose of these services is to topple the biggest name in the streaming services, Netflix Inc (NASDAQ:NFLX). The streaming giant has had a hard time this year, due to disappointing subscriber growth.

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Is ROKU Stock a Buy Or Hold on Disney, Apple & Streaming TV Growth?

The stock suffered a slump following its Q3 2019 financial results but since then it has regained much of the losses. While it is true that the losses widened from the year-ago period, experts believe that Roku is a stock that could have long term growth potential.

See For Yourself

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Biotechnology

2 Biotech Stocks to Watch As The Sector Hits New High

Joe Samuel

Published

on

best biotechnology stocks to buy sell

The biotech sector has thrown plenty of winners over the course of the last decade or so and if experts are to be believed then it is going to continued to do so for the foreseeable future. Great advancements are being made in the biotech industry and many companies are working on a highly advanced product.

In such a situation, it is imperative for an intelligent investor to look for companies worth investing in. One should watch the latest developments in the sector and track specific companies closely. Here is a look at two biotech stocks that are worth watching.

Neoleukin Therapeutics

top biotech stocks to watch list

The first biotech stock to watch is that of Neoleukin Therapeutics Inc (NLTX), which has managed to gain significantly over the past two weeks. On November 13, the company released its third-quarter results and since then it has rocketed by as much as 75%. The Canadian company made a loss of $59.1 million in the quarter, which worked out to $2.26 per share.

The company is a biopharmaceutical company that is involved in immunotherapies using de novo protein design technology. The company’s lead product candidate is NL-201, which is an amalgamation of both IL-2 and IL-15 and helps in removing alpha receptor binding.

Verastem

healthcare stocks to buy now

The other biotech stock that is worth watching is Verastem Inc (NASDAQ:VSTM). It made significant gains over the past week. On Monday, the company announced that it has submitted a Marketing Authorization Application for its product COPIKTRA to the European Medicines Agency.

COPIKTRA is a phosphoinositide 3-kinase. It’s meant for patients suffering from refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and relapsed or refractory follicular lymphoma (FL).

The company is seeking approval for the same in the European market. Verastem stated that it has seen significant improvement in patients who used the product. The stock rocketed by as much as 60% after the news broke and remains one of the stocks to watch this week.

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