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Sernova (SVA) (SEOVF) Finds C-Peptide In Phase I/II Fasting Patient

Jon Phillip

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Mr. Dominic Gray reports

SERNOVA CONFIRMS ENDURING LEVELS OF FASTING C-PEPTIDE IN BLOODSTREAM OF FIRST PATIENT IN ITS PHASE I/II CLINICAL TRIAL FOR TYPE-1 DIABETES

Sernova Corp. (SVA) (SEOVF) has detected enduring levels of C-peptide (measured up to 30 days and continuing), a biomarker of transplanted beta cell insulin production, in the bloodstream of a fasting patient in its continuing phase I/II Cell Pouch United States clinical study of type-1 diabetes.

The detection of fasting C-peptide in the bloodstream of our first patient, in addition to Sernova’s recent announcement of glucose-stimulated C-peptide and other early efficacy indicators, demonstrate a normalizing response of the Cell Pouch therapeutic cells to the body’s varied need for insulin production. This is an important step forward and evidence of ongoing islet engraftment within the Cell Pouch.

“Along with the preliminary safety and early indicators of efficacy, I am excited that we are observing C-peptide levels in the patient’s bloodstream after recent transplant, not only following stimulation with a meal but also when the patient is fasting. These findings represent progress in clinical outcomes and evidence of enduring islet survival and function within Sernova’s Cell Pouch,” said Dr. Piotr Witkowski, Director of Pancreatic, and Islet Transplant Program at the University of Chicago and study principal investigator. “We look forward to reporting ongoing results in additional patients as the trial progresses.”

The entry criteria of Sernova’s clinical study require patients to be C-peptide negative upon enrolment. C-peptide measured in the bloodstream is a biomarker of insulin and is widely used as a measure of insulin production by islet cells. C-peptide is typically measured following overnight fasting (fasting C-peptide) and during a glucose tolerance test (glucose-stimulated C-peptide). Together these measures provide an index of the patient’s ability to control blood glucose through their production of insulin.

With the goal of improved blood glucose control and stabilization of fluctuating blood sugar levels commonly experienced in people with type-1 diabetes, a normalizing response can also decrease the likelihood of life threatening hypoglycemic unaware events, a key efficacy measure in the Sernova trial.

Sernova’s clinical trial is continuing active recruitment and enrollment of study participants and further results will continue to be reported as the study progresses.

ABOUT SERNOVA’S CLINICAL TRAIL

Sernova is conducting a Phase I/II non-randomized, unblinded, single arm, company-sponsored trial, to assess the safety and tolerability of islet transplantation into the company’s patented Cell Pouch in participants with diabetes and hypoglycemia unawareness. The secondary objective is to assess efficacy through a series of defined measures. Importantly, patients enrolled in Sernova’s clinical trial are incapable of producing C-peptide prior to implantation of Sernova’s Cell Pouch and therapeutic cells.

Eligible subjects are implanted with Cell Pouches. Following development of vascularized tissue chambers within the Cell Pouch, subjects are then stabilized on immunosuppression and a dose of purified islets, under strict release criteria, transplanted into the Cell Pouch.

A sentinel pouch is removed for an early assessment of the islet transplant. Subjects are followed for additional safety and efficacy measures for approximately six months. At this point, a decision is made with regards to the transplant of a second islet dose with subsequent safety and efficacy follow up. Patients will be then further followed for one year to assess longer-term safety and efficacy.

For more information on this clinical trial, please visit www.clinicaltrials.gov/ct2/show/NCT03513939. For more information on enrollment and recruitment details please visit www.pwitkowski.org/sernova.

ABOUT SERNOVA’S CELL POUCH

The Cell Pouch is a novel, proprietary, scalable, implantable macro-encapsulation device designed for the long- term survival and function of therapeutic cells. The device is designed to incorporate with tissue, forming highly vascularized tissue chambers for the transplantation and function of therapeutic cells which then release proteins and hormones as required to treat disease. The device along with therapeutic cells has been shown to provide long-term safety and efficacy in small and large animal models of diabetes and has been proven to provide a biologically compatible environment for insulin-producing cells in humans.

ABOUT SERNOVA CORP.

Sernova Corp is developing regenerative medicine therapeutic technologies using a medical device and immune protected therapeutic cells (i.e., human donor cells, corrected human cells and stem-cell derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through replacement of proteins or hormones missing or in short supply within the body.

We seek Safe Harbor.

Disclaimer: Pursuant to an agreement between Midam Ventures LLC and Sernova (TSX:SVA) (OTC:SEOVF), Midam has been paid $350,000 for a period from September 23, 2019 to September 22, 2020. We may buy or sell additional shares of Sernova (TSX:SVA) (OTC:SEOVF) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about Sernova (TSX:SVA) (OTC:SEOVF). Click Here For Full Disclaimer.

© 2019 Canjex Publishing Ltd. All rights reserved. View original source: https://www.stockwatch.com/News/Item.aspx?bid=Z-C%3aSVA-2820121&symbol=SVA&region=C

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Biotechnology

3 Biotech Stocks To Watch As The Sector Heats Up

A. Lawrence

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top biotech stocks to watch list

When it comes to building a portfolio, money managers almost always ask their clients to diversify their portfolio. That’s in order to hedge against market risks. Hence, an investor needs to explore a wide range of sectors and choose stocks from those. One of the hottest sectors lately is the biotech sector.

It has managed to generate impressive growth over the past decade and remains a potentially high growth space for investors. On that note, here is a quick look at two biotech stocks that should be tracked by investors.

Biotech Stocks To Watch #1: GT Biopharma (GTBP)

GT Biopharma (GTBP) is a clinical-stage, immuno-oncology biotech company focused on innovative treatments based on its patent-pending TriKE™ technology. GT Biopharma (GTBP) is in good company within this space. Obviously you have the biotech giants:Gilead Sciences, Inc. (NASDAQ:GILD), Incyte Corporation (NASDAQ:INCY), &Merck & Co. (NYSE:MRK). But according to a recent article that was published on The Motley Fool it may be time for investors to give their attention to the “little guys” aka the Small Cap Stocks.

Within this article, The Motley Fool talks about 3 “Out of favor” “Cancer Treatment Stocks.” One of the companies is a small-cap stock that, according to the article, “sports marquee oncology partnerships with Gilead Sciences, Incyte, as well as Merck.” 

top biotechnology stocks to watch today

Similarly, when investors look at GT Biopharma (GTBP) they will notice that the company is indeed a small-cap stock and like the company The Motley Fool mentioned, has ties to a large entity to help further its own corporate missions. GT Biopharma (GTBP) has deep ties to the University of Minnesota & its prestigious Masonic Cancer Center, a comprehensive cancer center designated by the National Cancer Institute. Thanks to this relationship, GT Biopharma has been able to capitalize on several key developments:

GT Biopharma (GTBP) announces that Tim Schacker, M.D., Jeffrey S. Miller, M.D., and their colleagues at the University of Minnesota presented data showing its HIV-TriKE™ was able to kill HIV infected cells in the reservoir

GT Biopharma (GTBP) Announces Solid Tumor Targeting TriKe™ Kills Non-small Cell Lung Cancer (NSCLC) Tumor Cells

Read more on GT Biopharma Here.

Biotech Stocks To Watch #2: Jaguar Health (JAGX)

The first biotech stock to consider is that of Jaguar Health Inc (NASDAQ:JAGX), which made a major announcement at the end of October. That has resulted in the major rally in the stock through November and so far, the stock has gained as much as 45%. The company had announced that its fully owned subsidiary Napo Pharmaceutical has agreed on a distribution agreement with TannerGAP.

TannerGAP is part of the larger Tanner Pharma Group and will distribute the product Mytesi in places at which it is not yet registered. At this point in time, Mytesi is registered in Israel, the United States and Canada. Recently Jaguar also appointed Ian Wendt as its Vice President of Commercial Strategy.

On November 14 the company announced that Georgetown University ‘s Data Safety Monitoring Committee (“DSMC”) has reviewed the interim analysis for futility for the third-party, investigator-initiated Phase 2 HALT-D study evaluating the effectiveness of Mytesi® (crofelemer) for symptomatic relief in HER2 positive breast cancer patients receiving chemotherapy with trastuzumab, pertuzumab, and docetaxel or paclitaxel or trastuzumab, pertuzumab, carboplatin, and docetaxel (the “Study”). The DSMC has notified the Principal Investigator that the Study is allowed to enroll to completion. Enrollment in the Study now exceeds 85%, and the treatment period for each patient is 3 months.

SPECIAL REPORT | What Curing Cancer & HIV Could Mean for This Company, Its Investors & The World!

Biotech Stocks To Watch #3: Therapix Biosciences (TRPX)

The other biotech stock that warrants attention is that of Therapix Biosciences Ltd (NASDAQ:TRPX). The company is involved in developing treatments that are CBD based and today it announced top line results from the Phase 2A clinical study of its product THX-110. The study revealed that the product did, in fact, have a positive effect on patients who are afflicted with obstructive sleep apnea (OSA).

The study was conducted at the Assuta Hashalom Medical Center located in Israel and it represents a major positive for Therapix. After the news broke, the rocketed by as much as 19.45% and has emerged as one of the biotech stocks to watch for the rest of the week.

SPECIAL REPORT | What Curing Cancer & HIV Could Mean for This Company, Its Investors & The World!

best penny stocks Clovis Oncology (CLVS)

Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP), Midam has been paid $100,000 for a period from October 1, 2019 to November 15, 2019. We may buy or sell additional shares of GT Biopharma (GTBP) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about GT Biopharma (GTBP). Click Here For Full Disclaimer.

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Biotechnology

3 Biotech Stocks to Watch After Key, 4th Quarter Developments

Joe Samuel

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top biotech stocks to buy

Biotech stocks have been one of the best performing sectors for a few weeks now. It’s hardly surprising that many analysts believe that investors should have one or more of those stocks on their watch lists. However, when it comes to choosing a stock, an investor needs to be very diligent with research.

They also need to watch the market very closely for the latest movements. Making a list of the stocks to watch is the best way to go about it. On that note, here is a look at three biotech stocks solidifying big developments this quarter.

PharmaCyte Biotech (PMCB)

top biotech stocks to buy now

PharmaCyte Biotech (PMCB) is in the prep phase of clinical trials and readying to complete its Investigational New Drug Application for the FDA.  Whether you’re new to biotech stocks or a seasoned vet, you should understand how important milestones like this are for a company.

David A. Judd, a cellular biologist and a member of PharmaCyte’s Medical and Scientific Advisory Board, was recently interviewed. Right now, PharmaCyte Biotech (PMCB) is putting together the necessary material for its planned clinical trial for inoperable pancreatic cancer, one of the most deadly forms of cancer today.

“We are in the late stages of preparing an Investigational New Drug application (IND) to conduct a clinical trial involving patients with LAPC whose tumors no longer respond to either of these two first-line therapies,” stated Pharmacyte in a recent article*.  “We hope to be in a position to file our IND in 2019.  [Pharmacyte is] in the process of developing the final data we need to finish preparation of the IND by completing the second of two staggered and back-to-back manufacturing runs of our clinical trial product.”

As one report puts it, “Clinical trials are essential for the development of new treatments, and PharmaCyte will enter this upcoming trial with two essential goals in mind—the future of its pancreatic cancer treatment and the future of its technology.”

Dare Bioscience (DARE)

best penny stocks Clovis Oncology (CLVS)

The first biotech stock that should be put on the watch list is that of Dare Bioscience Inc (NASDAQ:DARE). The Dare stock has soared in yesterday’s session the back of a significant announcement from the company. Dare is involved in the development of innovative health solutions for women and today entered into an agreement to acquire the pioneering drug delivery technology developed by Microchips Biotech Inc.

The technology in question can help in storing and delivering hundreds of doses over a period of as much as a year. It is a significant development for Dare and the stock has jumped by as much as 8% after the news. This is definitely a stock that should be tracked closely.

Agenus (AGEN)

The other biotech stock that has made a strong start this week is that of Agenus Inc (NASDAQ:AGEN), an immuno-oncology company. on Monday, the company announced that it has reached a licensing agreement with UroGen Pharma Ltd for its product zalifrelimab. More importantly, Agenus has received $10 million upfront from UroGen and that sent the stock price higher by 9.24% on Monday.

November has been a good month for the stock and so far it has gained as much as 45%. It released its quarterly results on November 4 and it proved a pleasant surprise for investors. The loss per share came in at $0.33, which beat analysts’ estimates of $0.38. On the other hand, the revenues of $19.94 also managed to surpass analysts’ estimates by 27.82%.

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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

Biotech Stocks To Watch This Week

A. Lawrence

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With Biotech Continuing Higher, Are These Buys Or Sells This Week?

Biotech penny stocks have proven to be one of the best sectors for investments. That’s as far as the stock market is concerned. If experts are to be believed then it may continue to be among the best options in the years to come. That being said, it does not mean that investing in biotech stocks is an easy ride.

An investor needs to conduct a lot of research and also watch the market closely. Similar to other high-risk industries, volatility is a big factor. At any given point in time, a bad report could send stocks plummeting. Similarly, one good DA report can trigger a monster move. Here is a quick look at a few biotech penny stocks which made moves recently. Will they be better stocks to buy or avoid this month?

GT Biopharma Inc. (GTBP)

This company’s stock made new 3 month highs on October 22. GT Biopharma (GTBP) announced that its solid tumor targeting TriKE killed a non-small cell lung cancer tumor cell. This is a major development news for the company’s TriKE platform because the market potential for non-small lung cancer is big.

biotech stock to watch 2019

Non-small lung cancer accounts for 84% of all lung cancer diagnoses. Shareholders clearly felt this way, which may have been why GT Biopharma’s stock shot up by more than 25%.

There could be another potential reason why stockholders are reacting this way to the recent news. Earlier in October, the company announced that the design of HIV-TriKE was able to successfully target the HIV-Env protein.

This would allow the company’s TriKE technology to eliminate replicating HIV infected cells. Because of the success of TriKE with lung cancer cells, investors might feel that the company will be able to successfully destroy HIV cells. For more on GT Biopharma’s novel treatment pipeline and progress, click here.

WHAT CURING CANCER & HIV COULD MEAN FOR THIS COMPANY, ITS INVESTORS & THE WORLD!

Pieris Pharmaceuticals (PIRS)

The first stock to consider in the biotech sector with regards to the latest movements is that of Pieris Pharmaceuticals Inc (NASDAQ:PIRS). Back on November 5, the company announced that dose escalation monotherapy data with regards to one of its products is going to be presented at the Immunotherapy of Cancer (SITC) Annual Meeting that is going to be held at National Harbor, Maryland.

stock_price_mental

The medicine in question is PRS-343, which is meant for treating HER2-positive solid tumors. It goes without saying that it is a positive development and the Pieris stock has reacted positively to the news as well. Since the news broke, the stock has gained as much as 10%.

WHAT CURING CANCER & HIV COULD MEAN FOR THIS COMPANY, ITS INVESTORS & THE WORLD!

Foamix Pharmaceuticals (FOMX)

The other biotech stock that has been on a tear for much of the week is the Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) stock. Back on October 18, the company announced that one of its products known as AMZEEQ has been approved by the United States Food and Drug Administration. The medicine in question is a topical foam and is meant for treating inflammatory lesions in both adults as well as pediatric patients, who are older than 9. That was the initial trigger for the rise in the stock price.

Last week, the company also published a peer review of the long term open-label safety of AMZEEQ and that proved to be the trigger for the rally. During the course of the week so far, the Foamix stock has soared by as much as 60%. This is a stock that should definitely be tracked by investors.

WHAT CURING CANCER & HIV COULD MEAN FOR THIS COMPANY, ITS INVESTORS & THE WORLD!

biotechnology stocks to buy

Pursuant to an agreement between Midam Ventures LLC and GT Biopharma (GTBP), Midam has been paid $100,000 for a period from October 1, 2019 to November 15, 2019. We may buy or sell additional shares of GT Biopharma (GTBP) in the open market at any time, including before, during or after the Website and Information, to provide public dissemination of favorable Information about GT Biopharma (GTBP). Click Here For Full Disclaimer.

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