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Finch Therapeutics Announces Removal of FDA Clinical Hold on CP101 IND

SOMERVILLE, Mass., April 28, 2022 (GLOBE NEWSWIRE) -- Finch Therapeutics Group, Inc. (“Finch” or “Finch Therapeutics”) (Nasdaq: FNCH), a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery® platform to develop a novel class of orally administered biological drugs, today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Finch’s investigational new drug (IND) application for CP101. CP101 is the Company’s investigational orally administered microbiome therapeutic which is in late-stage clinical development for the prevention of recurrent C. difficile infection (CDI). The FDA lifted the clinical hold following a review of information Finch provided related to its SARS-CoV-2 screening procedures and associated informed consent language.

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Finch Therapeutics Announces Removal of FDA Clinical Hold on CP101 IND

HilleVax Announces Pricing of Upsized Initial Public Offering

BOSTON, April 28, 2022 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today announced the pricing of its upsized initial public offering of 11,765,000 shares of common stock at an initial public offering price of $17.00 per share. All of the shares are being offered by HilleVax. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $200.0 million. The shares are expected to begin trading on the Nasdaq Global Select Market on April 29, 2022 under the ticker symbol “HLVX.” The offering is expected to close on May 3, 2022, subject to the satisfaction of customary closing conditions. In addition, HilleVax has granted the underwriters a 30-day option to purchase up to an additional 1,764,750 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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HilleVax Announces Pricing of Upsized Initial Public Offering

New three-year data for Roche’s Evrysdi (risdiplam) show long-term improvements in survival and motor milestones in babies with Type 1 spinal…

Basel, 29 April 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new three-year data from the FIREFISH study, including one-year data from the open label extension, reinforcing the long-term efficacy and safety of Evrysdi® (risdiplam) in infants with symptomatic Type 1 spinal muscular atrophy (SMA). The data showed an estimated 91% of infants (n=58) treated with Evrysdi were alive after three years of treatment. The Evrysdi-treated infants continued to improve or maintain motor functions, including the ability to swallow, sit without support, stand with support and walk while holding on, between two and three years of treatment. Without treatment, children with Type 1 SMA are never able to sit without support. The study also showed overall continued reductions in serious adverse events (SAEs) and hospitalisations over time.

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New three-year data for Roche’s Evrysdi (risdiplam) show long-term improvements in survival and motor milestones in babies with Type 1 spinal...

A New Type of Cell Death Discovered in Fly Guts – Neuroscience News

Summary: Researchers have uncovered a new type of cell death that occurs in the guts of flies. The process, called erebosis, is believed to play a role in gut metabolism.

Source: RIKEN

A research group led by Sa Kan Yoo at the RIKEN Center for Biosystems Dynamics Research (BDR) has discovered a completely unknown type of cell death that takes place in the guts of the common fruit fly.

The new process, coined erebosis by the researchers is thought to play a role in gut metabolism. The findings necessitate a revision of the conventional concept of cell death, and at the same time, overturn the previously established theory of tissue homeostasis in the gut.

The study was published April 25 in scientific journalPLOS Biology.

Like the skin, cells that make up the intestines are constantly dying and being replaced by new cells. This process, called turnover, helps maintain the balance, or homeostasis, between tissue growth and tissue renewal. The conventional theory for turnover in the intestines is that aging or damaged cells die through a process called apoptosis.

Also called programmed cell death, apoptosis is one of three types of cell death that are currently recognized.

The new research calls this assumption into question, providing evidence for a second type of programmed cell death that could be specific to the intestines.

As is often the case, this discovery occurred by accident. The researchers were studying a fruit fly version of ANCE, an enzyme that helps lower blood pressure. They noticed thatAnceexpression in the fly gut was patchy, and that the cells that contained it had strange characteristics.

We found that Ance labels some weird cells in the fruit fly gut, says Yoo.

But it took a long time for us to figure out that these weird cells were actually dying. They found that the strange cells were dark, lacking nuclear membranes, mitochondria, and cytoskeletons, and sometimes even DNA and other cellular items that are needed for cells to stay alive.

The process was so gradual and unlike the more sudden and explosive cell death seen in apoptosis, that they realized it might be something new.

Because the Ance-positive cells were often near where new cells are born in the gut, they theorized that the new type of cell death is related to turnover in the intestines.

They tentatively named the process erebosis, based on the Greek erebos meaning darkness, because the dying cells looked so dark under the microscope.

To prove erebosis is a new type of cell death, the researchers conducted several tests. First, experimentally stopping apoptosis did not prevent gut homeostasis. This meant that cell turnover in the gut, including cell death, can proceed without apoptosis.

Second, the dying cells did not show any of the molecular markers for apoptosis or the other two types of known cell death. Cells in late-stage erebosis did show a general marker for cell death related to degraded DNA.

Detailed examination of the cells in which erebosis was occurring revealed that they were located near clusters of gut stem cells. This is good evidence erebotic cells are replaced by newly differentiated gut cells during turnover.

Ironically, the enzyme that led to this discovery does not seem to be directly involved in the process, as knocking down or overexpressing Ance did not affect turnover or erebosis. Therefore, the next step is work out the detailed molecular events that allow erebosis and cell turnover in the fly gut.

I feel our results have the potential to be a seminal finding. Personally, this work is the most groundbreaking research I have ever done in my life. says Yoo, We are keenly interested in whether erbosis exists in the human gut as well as in fruit flies.

Author: Masataka Sasabe Source: RIKEN Contact: Masataka Sasabe RIKEN Image: The image is credited to RIKEN

Original Research: Open access. Erebosis, a new cell death mechanism during homeostatic turnover of gut enterocytes by Sa Kan Yoo et al. PLOS Biology

Abstract

Erebosis, a new cell death mechanism during homeostatic turnover of gut enterocytes

Many adult tissues are composed of differentiated cells and stem cells, each working in a coordinated manner to maintain tissue homeostasis during physiological cell turnover. Old differentiated cells are believed to typically die by apoptosis.

Here, we discovered a previously uncharacterized, new phenomenon, which we name erebosis based on the ancient Greek word erebos (complete darkness), in the gut enterocytes of adultDrosophila. Cells that undergo erebosis lose cytoskeleton, cell adhesion, organelles and fluorescent proteins, but accumulate Angiotensin-converting enzyme (Ance).

Their nuclei become flat and occasionally difficult to detect.

Erebotic cells do not have characteristic features of apoptosis, necrosis, or autophagic cell death. Inhibition of apoptosis prevents neither the gut cell turnover nor erebosis.

We hypothesize that erebosis is a cell death mechanism for the enterocyte flux to mediate tissue homeostasis in the gut.

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A New Type of Cell Death Discovered in Fly Guts - Neuroscience News

Stem Cell Magic: 5 Promising Treatments For Major Medical Conditions – Study Finds

Embryonic mitosis stem cells colony tissue section magnified in microscope, 3D illustration. ( Eduard Muzhevskyi - stock.adobe.com)

Stem cells are key building blocks for the human body. At the start of life, they divide over and over again to create a fully developed baby from an embryo. Many individuals now even turn to services that store and preserve umbilical cords should a person ever be in need.

Stem cells have the potential to develop into different types of cells in the body, serving as a repair system of sorts for damaged or lost cells. In recent decades, scientists have shown the miraculous ways of medicine through stem cell treatments.

So just how are doctors using stem cells to treat and help heal people battling various ailments? Heres a look at five studies published on StudyFinds that demonstrate the wondrous ways of stem cell treatments.

A heart condition called dilated cardiomyopathy, or DCM, weakens muscles of the ventricles, which causes heart failure and often death in children. Currently, the only cure is a heart transplant, which can take long periods of time to find an acceptable donor and increases the risk of rejection of the donor tissue. One study finds that stem cell therapy could help DCM patients survive longer while awaiting a transplant or potentially eliminate the need for a new heart entirely.

Cardiac stem cells called cardiosphere-derived cells (CDCs) have proven to be effective at treating certain heart conditions. The CDCs grow into tissue cells of the heart and can counter the effects of DCM. To test the safety of the CDC therapy, a team of scientists at Okayama University in Japan demonstrated the efficacy of CDCs in tissue damaged from DCM. For the study, DCM symptoms were induced in pigs, after which CDCs were administered in various doses for treatment. In a control group, some pigs were given a placebo.

Results showed thickening of the heart muscle in pigs who were given the stem cell treatment. This allows increased blood flowto the rest of the body, thereby effectively repairing the damaged tissue. Due to the dosage used in animal trials, researchers could estimate the proper dosage for human trials.

The first of these included 5 younger patients who were diagnosed with DCM. Injections of CDCs resulted inbetter heart function without any serious side effects. Thus, scientists believe this type of treatment could minimize the need for heart transplants and allow DCM patients to have normal lives.

READ MORE: Stem cell treatment shows promise as treatment for rare heart condition in children

Although their use is sometimes controversial, scientists often look at stem cells as a potential miracle cure for many conditions. One study finds stem cells from a babys umbilical cord may save the most at risk of dying from COVID-19. A treatment derived from non-altered versions of these stem cells significantly improves the survival rate among coronavirus patients already on a ventilator.

In a double-blind, controlled, randomized study, 40 adultpatients in intensive careand on a ventilator received the treatment intravenously. The infusions contained stem cells coming from the connective tissue of a human umbilical cord. Half of the patients received infusions not containing stem cells to serve as a control group.

Results reveal survival rates climbed by 2.5 times among patients receiving stem cells. Those with a pre-existing health problem, making them high-risk for COVID, saw their changes of beating coronavirus jump by 4.5 times. Moreover, the study says the stem cell infusions did not cause any life-threatening complications or allergic reactions.

READ MORE: Stem cells from a babys umbilical cord doubles survival chances among COVID patients

In the fight against heart disease, a new super-weapon is now even closer to deployment, and its capabilities are turning out to be beyond expectations. A study aimed at combating heart disease finds that stem cells are not only showing promise in treating heart failure, but in rats are actually reversing problems associated with old age.

The specific type of stem cells used in the study are cardiosphere-derived cells, or CDCs. While the latest research involving CDCs indicates possibilities that have previously been in the realm of science fiction, the scientists leading the charge urge restraint in face of the excitement.

Nevertheless, the latest results of stem cell infusions in rats are startling. Not only did rats that received the CDCs experience improved heart function, they also had lengthened heart cell telomeres. Moreover, the rats that received the treatment also had their exercise capacity increase by about 20 percent. They also regrew hair faster than rats that didnt receive the cells.

Still, the doctors and scientists working to push the frontier of medicine forward are very optimistic about the real possibilities of the therapy. Researchers of the study said they are also studying the use of stem cells in treating patients with Duchenne muscular dystrophy and patients with heart failure with preserved ejection fraction, a condition that affects more than 50 percent of all heart failure patients.

READ MORE: Study: Cardiac stem cell injections reverse effects of aging

A new biomaterial can help regenerate tissue in people dealing with chronic lower back pain and spinal issues. A recent study finds the secret to this breakthrough therapy is all in the hiPS. Not thosehips, but human induced pluripotent stem cells.

The study explains that a common cause of lower back pain is the degeneration of intervertebral discs (IVDs). These discs sit between the vertebrae in the spine and help give the spinal column its flexibility. Severe IVD degeneration eventually leads to spinal deformity without treatment. In this study, scientists used cartilage tissue derived from stem cells to build back lost IVDs in lab rats.

Study authors used induced pluripotent stem cells (iPSCs) during their experiments. Importantly, scientists are capable of turning iPSCs into chondrocytes cells that produce and maintain cartilage. Previous studies have successfully used this same method to treat cartilage defects in animals. In the new study, researchers created human iPSC-derived cartilaginous tissue (hiPS-Cart) that they implanted into rats with no NP cells in their intervertebral discs.

Findings reveal that the hiPS-Cart implanted in the rats was able to survive and be maintained. IVD and vertebral bone degeneration were prevented. The researchers also assessed the mechanics and found that hiPS-Cart was able to revert these properties to similar levels observed in the control rats.

READ MORE: Stem cell cure for lower back pain is all in the hiPS

Stem cells taken from deceased patients may also help in creating a cure for blindness. Retina cells from a corpse continue to survive after being transplanted into the eyes of monkeys, scientists say.

RPE dysfunction is a leading cause of blindness, including causing disorders likemacular degeneration, which affects around 200 million people worldwide. Now, for the first time, scientists have successfully produced retina cells in monkeys using human stem cells. Human cadaver donor-derived cells can be safely transplanted underneath the retina and replace host function, and therefore may be a promising source for rescuing visionin patients with retina diseases.

For the study, researchers transplanted stem cells from the eyes of donated bodies under the monkeys macula, the central part of the retina. Following surgery, the transplanted patches remained stable for at least three months without any serious side-effects. The RPE created by the human stem cells partially took over from the old retina cells. In addition, this could successfully support the eyes light receptorswithout causing retinal scarring.

These unique cells could serve as an unlimited resource of human RPE, whichmay restore sightfor millions of people around the world. The scientists caution that they will need to conduct more research to see how the procedure works with human transplant patients. Human trials are still a long way off.

READ MORE: Eye stem cells transplanted from corpses to live patients could cure blindness

For more information on each of these stem cell treatments, you can refer to the READ MORE links in between each section.

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Stem Cell Magic: 5 Promising Treatments For Major Medical Conditions - Study Finds