Palm Beach, FL –November 13, 2019 – For decades researchers have been trying to find newer and more effective ways to fight cancer cells. Today much research is focused on attacking the cancerous cells growth. The reasoning is that denying these cells energy, they will die. The idea is that by using targeted therapies only the cancerous cells will be affected. An article in Scientific American discussed this approach. “On any given day, there are often more than 100 news articles focused on cancer, many of which speak to new and promising studies or breakthroughs in a research lab. The desperation for better treatment options is palpable. And it is no wonder, since one in three people will be diagnosed with cancer in their lifetime. While cancer research and treatments have made great strides, cancer is still far too common, which raises the question: What is missing? Traditional cancer treatments such as chemotherapy, radiation and immunotherapy have grown by leaps and bounds, but they each have their limitations. Chemotherapy can be very effective and is still the standard of care, but it shuts down the immune system in the process and recurrence is often likely, among many other concerns. Most types of radiation cannot reach all parts of the body, and therefore cannot be used for cancers that have spread. Finally, the medical community is increasingly hopeful about advances made in immunotherapy, but it is still only 20 to 30 percent effective in some cancers, and completely ineffective in others. Active biotech and pharma companies in the markets this week include Moleculin Biotech, Inc. (NASDAQ: MBRX), Amarin Corporation plc (NASDAQ: AMRN), Kadmon Holdings, Inc. (NYSE: KDMN), Pfizer Inc. (NYSE: PFE), Acasti Pharma Inc. (NASDAQ: ACST) (TSX-V: ACST).
There is another type of cancer treatment, however, known as cell metabolic therapy, which has been researched and discussed for decades without producing viable treatment options. Cell metabolic therapy targets the mitochondria—energy producers—of cancer cells, shutting down their growth and preventing them from spreading. If we remove the energy source that these cells use to power their attack on the body, we can stop the disease dead in its tracks. There are many reasons why cell metabolic therapy has failed in previous decades, but recent data are demonstrating that it is finally turning a corner. The Scientific American article mentioned “Today, we understand that the metabolic transformation from a healthy cell to a cancer cell involves mitochondria, not only for generating energy but also to produce biosynthetic intermediates, the building blocks used to support new cell growth and proliferation. Therefore, by targeting the mitochondria of cancerous cells, we can diminish their ability to grow—hitting cancer where it hurts the most. In fact, we are seeing a renewed interest with researchers exploring the metabolic emergence of cancer cells to facilitate the discovery and development of new therapies.”
Moleculin Biotech, Inc. (NASDAQ:MBRX) BREAKING NEWS: Moleculin Announces Beginning of Preclinical Development of New Approach to Pancreatic Cancer – Moleculin Biotech, a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, announced it has begun preclinical testing of its drug candidate, WP1122, which it believes may present a new approach to treating highly glycolytic tumors like pancreatic cancer and glioblastoma.
“WP1122 represents an opportunity to attack the metabolism of cancer by exploiting the Warburg principle, which explains that some tumors are highly dependent on glycolysis, a specific metabolism of glucose, for growth and survival,” commented Walter Klemp, Moleculin’s Chairman and CEO. “What this means in practice is that tumors are vulnerable by being highly dependent on glucose availability. Cancer cells often to consume up to 18 times as much glucose as their healthy normal cells neighbors, suggesting that we may be able to starve tumors by supplying them with glucose decoys that would inhibit glucose-based energy production. However, until the creation of WP1122, glucose decoys like 2-deoxy-D-glucose (‘2-DG’) lacked the drug-like properties to be effective, primarily because of rapid metabolism and a very short circulation time in the body, which then limits desired organ and tumor uptake.”
Dr. Don Picker, Chief Science Officer for Moleculin, added: “WP1122 is a prodrug of 2-DG that has been shown in animal models to significantly increase the half-life of 2-DG and allows for increased uptake to targeted organs and tumors like the brain tumors and pancreatic cancer. Recent discoveries now also suggest that such a glucose decoy could critically impact a process known as glycosylation and glycan formation and that this type of activity can directly impact the function of PD-L1, enabling increased immune system response to cancer cells. We have been working on the clinical formulation of WP1122 for some time, and we are eager to now be taking the next key steps to getting WP1122 into the clinic.” Read this and more news for MBRX at: https://financialnewsmedia.com/news-mbrx/
Other recent developments in the biotech industry include:
Amarin Corporation plc (NASDAQ: AMRN) recently announced a summary of results from a patient-level, cost-effectiveness analysis of icosapent ethyl (Vascepa). This comprehensive analysis evaluated the cost-effectiveness of icosapent ethyl in reducing cardiovascular (CV) risk among high-risk patients as demonstrated in the landmark REDUCE-IT®2 cardiovascular outcomes study. In this newly reported analysis, use of icosapent ethyl was projected to not only be cost-effective but also to reduce long-term health care costs in a majority of the scenarios analyzed.
The findings were disclosed in an abstract titled, “Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT,” in connection with the 2019 Scientific Sessions of the American Heart Association (AHA), scheduled for November 16 – 18 in Philadelphia, PA. William S. Weintraub, M.D., director of Outcomes Research with MedStar Cardiovascular Research Network, and lead author of the analysis, is scheduled to present the results in more detail at AHA on Saturday, November 16, at 7:30 a.m.
Kadmon Holdings, Inc. (NYSE: KDMN) announced positive topline results from the planned interim analysis of ROCKstar (KD025-213), the fully enrolled pivotal trial evaluating KD025 in patients with chronic graft-versus-host disease (cGVHD) who have received at least two prior lines of systemic therapy. The trial met the primary endpoint of Overall Response Rate (ORR) at the interim analysis, which was conducted as scheduled two months after completion of enrollment.
KD025 showed statistically significant ORRs of 64% with KD025 200 mg once daily (QD) (95% Confidence Interval (CI): 51%, 75%; p<0.0001) and 67% with KD025 200 mg twice daily (BID) (95% CI: 54%, 78%; p<0.0001). KD025 has been well tolerated and adverse events have been consistent with those expected in the patient population.
Pfizer Inc. (NYSE: PFE) announced that positive results from a Phase 3 investigational study of tofacitinib in children and adolescents aged two to less than 18 with juvenile idiopathic arthritis (JIA) will be presented for the first time during a late-breaking oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting (November 8-13, Atlanta, GA). The study of tofacitinib in JIA is investigative and JIA is not an FDA-approved indication for XELJANZ. Pfizer has plans to file for the indication in 2020.
The JIA study is a Phase 3, randomized, double-blind, placebo-controlled withdrawal study that included 225 patients with polyarticular course JIA (n=184), psoriatic arthritis (n=20) or enthesitis related arthritis (n=21). The study evaluated the efficacy and safety of tofacitinib taken as either a 5 mg tablet or as a 1 mg/mL oral solution twice daily based on the subject’s body weight.
Acasti Pharma Inc. (NASDAQ: ACST) (TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (HTG), announced the publication as Articles in Press of a CaPre pharmacokinetics study, entitled, “Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers” in a leading peer-reviewed journal, Clinical Therapeutics. The study publication is available online and can be accessed at: https://www.clinicaltherapeutics.com/article/S0149-2918(19)30499-0/fulltext.
In this Phase I, open-label, randomized, multiple-dose, single-center, parallel-design study, 42 healthy volunteers received a single dose of CaPre (OM3-PL/FFA) at day 1, followed by multiple oral doses of 1, 2, and 4 grams per day for 14 days.
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