LAGUNA HILLS, Calif.–(BUSINESS WIRE)–
PharmaCyte Biotech, Inc. (PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that its partner, Austrianova Singapore (Austrianova), has successfully completed the second and final GMP manufacturing run to produce PharmaCyte’s clinical trial product. The product is now ready for “release testing.” The data from the “release testing” of both manufacturing runs will be included in an Investigational New Drug application (IND) and submitted to the U.S. Food and Drug Administration (FDA) to support PharmaCyte’s planned clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC).
The capsules, which are fully filled with genetically modified live cells, were immediately put into PharmaCyte’s clinical trial syringes and then frozen. Austrianova has shipped a representative sample of the frozen syringes to third-party laboratories in Europe to undergo “release testing” related to the “safety” of the product. Austrianova will conduct “release testing” in-house related to the “functionality” of the encapsulated cells.
PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, “Today is a great day at PharmaCyte. We have cleared what was a major hurdle for us and have completed our most impactful milestone to date. Successfully completing two manufacturing runs is a milestone that has now been met as we progress toward our submission of an IND to the FDA so we can begin our clinical trial in LAPC.
“Our GMP consultant, cGMP Validation, has informed us that while two successful manufacturing runs are not required by the FDA to request a Phase 2b clinical trial, it could go a long way in demonstrating to the FDA that our manufacturing process is robust and reproducible – manufacturing qualities that are highly embraced by the FDA.”
To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, we encourage you to watch the company’s 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.
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/20191118005412/en/
Dr. Gerald W. Crabtree
PharmaCyte Biotech, Inc.
Investor Relations Department
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.
2 Biotech Stocks To Watch Before Next Week
Biotech has been one of the hottest sectors to invest in for quite a few years. Nowadays, investors are almost always on the lookout for the next big thing from among those stocks. However, when it comes to identifying stocks, an investor needs to do his fair share of research and then decide on his next course of action.
Additionally, one could also watch the market closely and keep track of the latest movements in penny stocks in order to identify potential winners. Here is a look at two biotech stocks which could be of interest to investors.
Biotech Stocks To Watch: Marinus Pharmaceuticals
The first biotech stock to bring under consideration is Marinus Pharmaceuticals Inc (NASDAQ:MRNS) which has made significant gains on Wednesday on the back of an important announcement.
On Wednesday, the company announced that it is going to make a simultaneous public offering of its common stock and private placement. The total value of these two offerings is going to be $65 million. The news resulted in a 38% bump in the stock price in yesterday’s trading session.
Earlier this week, the company announced that it has started its Phase 2 trial for its product ganaxolone as well. The medicine in question is supposed to treat tuberous sclerosis complex and it goes without saying that it is a significant milestone for Marinus.
Biotech Stocks To Watch: Diffusion Pharmaceuticals
The other biotech stock that could be worth tracking is that of Diffusion Pharmaceuticals Inc (NASDAQ:DFFN). The company announced positive data with regards to the Phase 3 study its product Trans Sodium Crocetinate (TSC) plus standard of care (SOC). The data showed that there was an improvement in the condition of patients suffering from inoperable glioblastoma multiforme.
It proved to be a major trigger for the Diffusion stock and after the announcement was made on Tuesday, the stock has rallied by as much as 31.40%. It is a stock that could be worth watching over the coming days.
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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. FULL DISCLAIMER HERE
Are These Biotech Stocks To Buy Or Sell Right Now?
2 Biotech Stocks Rally But Can That Continue?
One of the sectors that have proven to be a consistently steady performer in the stock market over the past few years is the biotech sector. Hence, it is not really a surprise that investors are almost always on the lookout for the next big thing among biotech stocks.
However, it is important to note that even though biotech is a prosperous sector, an investor needs to put in his fair share of research in order to discover potential winners. Here is a look at two biotech stocks that could be tracked by investors closely over the coming days.
Vistagen Therapeutics Gains As FDA Grants fast track designation for PH94B
The first one to consider is that Vistagen Therapeutics Inc (VTGN Stock Report) that made significant gains after the company made a major announcement with regards to one of its products. The company announced on Tuesday that its social anxiety disorder product PH94B has been granted fast track designation by the United States Food and Drug Administration.
As everyone knows, it is a significant milestone for the company as it tries to bring the product to the market and the market naturally reacted positively to the news. The stock shot up by as much as 44.60% on the back of the news and has emerged as one of the biotech stocks that could be tracked closely today.
Iterum Therapeutics up 280% in 3 Weeks
The other biotech stock that has made a significant move this morning is that of Iterum Therapeutics PLC (NASDAQ:ITRM). On Tuesday, the stock rallied by as much as 22% but there was no material news with regards to the company that could have triggered that sort of a rally. However, last month, the company had made a major announcement about one of its products.
Iterum announced that it had completed enrolment of patients for the study of Sulopenem for Resistant Enterobacteriaceae (SURE). The medicine meant for treating complicated urinary tract infections. The stock has rallied by as much as 270% since the news broke back on November 18.
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