Stem Cell Clinic

Genenta to Appoint Stephen Squinto, Experienced Biotech Executive and Investor, as Chairman – BioSpace

MILAN, Italy and NEW YORK, Nov. 23, 2020 (GLOBE NEWSWIRE) -- Genenta Science, a clinical-stage biotechnology company pioneering the development of a hematopoietic stem progenitor cell gene therapy for cancer (Temferon), announced that highly experienced biotech executive and investor Stephen Squinto, PhD joint Genenta and will be appointed as Chairman of its Board of Directors.

The appointment will be effective with the approval of the Genenta Shareholders Meeting. Pierluigi Paracchi, currently Chairman and Chief Executive Officer of Genenta, will continue to serve as CEO.

Dr Squinto is currently Executive Partner of the healthcare investment company OrbiMed Advisors and has more than 25 years experience in the biotech industry, including as Chief Executive Officer of the gene therapy company Passage Bio. He was a co-founder of Alexion Pharmaceuticals, where he served as Chief Global Operations Officer and Global Head of Research, and previously held several senior leadership positions at Regeneron Pharmaceuticals.

Dr Squinto currently serves on the Board of Directors of a several biotech and healthcare companies and has received numerous honors and awards from academic and professional organizations for his scientific work. He received his PhD in Biochemistry and Biophysics from Loyola University of Chicago.

Pierluigi Paracchi, CEO of Genenta, said: I am delighted to welcome Steve Squinto to Genenta as our new Chairman. Steve will provide valuable input and guidance to the development on Genenta, based on his outstanding and extensive time in biotech industry. In particular, his time as CEO of the gene therapy company Passage Bio provides a clear parallel to Genenta, as we continue to develop the stem cell gene therapy Temferon.

Stephen Squinto said: It as honor to be invited to be Chairman of Genenta, a truly exciting company which has the potential to revolutionize the way we treat cancer through its novel immuno-gene therapy Temferon. I am looking forward to working with the outstanding team already in place to progress this treatment, which has potential against a broad range of tumors both as first line and as combination therapy, further through clinical trials and towards market.

About Genenta Science

Genenta (www.genenta.com) is a clinical-stage biotechnology company pioneering the development of a proprietary hematopoietic stem cell gene therapy for cancer. Temferon is based on ex-vivo gene transfer into autologous hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). Temferon, which is under investigation in a Phase I/II clinical trial in newly diagnosed Glioblastoma Multiforme patients, is not restricted to pre-selected tumor antigens nor type and may reach solid tumors, one of the main unresolved challenge in immuno oncology. Based in Milan, Italy, and New York, USA, Genenta has raised 33.6 million (~$40 million ) in three separate rounds of financing.

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Genenta to Appoint Stephen Squinto, Experienced Biotech Executive and Investor, as Chairman - BioSpace

Exploring First-line Therapies in Peripheral T-Cell Lymphomas – Targeted Oncology

During the Targeted Oncology Case Based Peer Perspectives event, Javier L. Munoz, MD, Hematologist/Oncologist Director, Lymphoma Program Mayo Clinic, discussed the case of 60-year-old patient with peripheral T-cell lymphoma (PTCL).

Targeted Oncology: What are the standard regimens in treating T-cell lymphoma?

MUNOZ: Historically, we have been prescribing CHOP [cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone] or CHOP-like regimens. There are retrospective German data showing the addition of etoposides, so CHOEP instead of CHOP, may be beneficial, particularly for patients who were younger than 65 years.1 That is not a randomized trial, it was a retrospective study, so the strength of the data was relatively weak.1 The data of brentuximab vedotin [Adcetris] plus CHP [cyclophosphamide, doxorubicin, prednisone] versus CHOP [was from] a randomized trial, so its a stronger level of evidence compared with that etoposide data.

What do the National Comprehensive Cancer Network (NCCN) guidelines recommend?

The category 1 recommendation for ALCL [anaplastic large cell lymphoma] is brentuximab vedotin plus CHP, according to the NCCN.2 For that particular indication, I think most people are not going to argue that brentuximab plus CHP is the way to go.

For the other subtypesand numbers for the other subtypes were smaller compared with ALCLits a bit more blurry. You still have brentuximab vedotin plus CHP, but you also have the options of CHOP, CHOEP.

What was the rationale for ECHELON-2 [NCT01777152] in this population? This was a randomized study, brentuximab vedotin plus CHP versus CHOP.3 The bottom line is that this trial was a replacement strategy. Vincristine, or Oncovin, is a vinca alkaloid, and it causes neuropathy. For brentuximab, an antibody-drug conjugate, its payload is also a vinca drug. Vinca alkaloids cause neuropathy, so the trial replaced those agents, resulting in this trial. It was a double-dummy, [double-blind] study, so patients received placebobrentuximab and CHP or they received CHOP. The CD30 expression needed to be 10% or higher for the patient to be able to enroll. The investigators allowed multiple subtypes of T-cell lymphomas: PTCL not otherwise specified, angioimmunoblastic T-cell lymphoma, hepatosplenic T-cell lymphoma, enteropathy-associated T-cell lymphoma.

The reality is that most of you are going see PTCL, not otherwise specified, because its the most common subtype I see; maybe the runner-up is angioimmunoblastic T-cell lymphoma, and then the next one is going to be ALCL. And again, there are a couple of flavors: ALK-positive and ALK-negative. ALK-negative is, prognostically, closer to PTCL. The primary end point was progression-free survival [PFS] but, of course, they looked at other things like overall survival.3

What were the outcomes of this trial for patients? PFS was a primary end point, and this was the most important factor or variable that they looked at, and with CHOP you get 20.8 months of PFS; with brentuximab plus CHP you got 48.2 months. So, more than double the primary end point, and that is why I like to start with PTCL, because ECHELON-2 definitely looked more impressive than the ECHELON-1 trial [NCT01712490]. Theyre both important papers; ECHELON-1 was published in New England Journal of Medicine,4 ECHELON-2 was only published in Lancet. The difference, the numbers that you see, are more dramatic in ECHELON-2 in PTCL compared with Hodgkin lymphoma, but both are relevant papers. More than double the results, and you could see that that separation is maintained over time.

They looked at overall survival, and there was also a difference. Even though the primary end point was PFS, your patients are also going to live longer if you go with brentuximab plus CHP.

The complete response rate was 68% for [brentuximab vedotin plus CHP] versus 56% for CHOP. Of course, the objective response rate is also higher for brentuximab plus CHP, as well [TABLE5 ].

As I said, both drugs can potentially cause neuropathy. Lets take a look at the safety profile. Peripheral neuropathy for brentuximab plus CHP, grade 3 or higher, was 4%, for CHOP, it was 3%. Remember, vincristine in the CHOP regimen can also cause neuropathy. Not a big difference there. For any grade of neuropathy, the numbers are 45% for brentuximab plus CHP and 41% for CHOP.

Now, could you die from CHOP, or brentuximab plus CHP? Of course. Luckily for us, its single digits. Its rareIm sure that we have all had patients that we have lost during CHOP or R-CHOP [rituximab (Rituxan) plus CHOP] for B-cell lymphomas, but 3% for brentuximab plus CHP and 4% for CHOP.

If this patient achieved a complete response to frontline therapy, would you consider transplant?

Before the ECHELON trials, most of us knew that CHOP was suboptimal; we just did not know what was better than CHOP. Thats why we were playing with etoposide, based on that retrospective German data and doing CHOEP, sometimes even EPOCH [etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride] for these patients. Because CHOP was suboptimal, we wanted to do something additional, and that is why many patients have received consolidation with transplants.

We consider so many factors for transplant-eligible patientsthe performance status, comorbidities, age; but in general, Im prone to offer [transplant] to patients who have these T-cell lymphomas because, again, its a bad disease, and its not a curative intent. You are not giving the treatment with a curative intent. You want to keep the disease at bay as much as possible.

What is the impact of consolidative stem cell transplant after frontline brentuximab plus CHP for patients?

In a post hoc analysis, for the patients who achieved complete remission [CR], 38 patients in CR, received the transplant, and 76 patients in CR did not; it was certainly not the primary end point.5 It was presented at the American Society of Hematology Annual Meeting in 2019. Again, we are tempted to prescribe the transplant because, historically, these patients have done so poorly. The majority of these patients in CR after brentuximab plus CHP did not receive a transplant, 38 patients did receive a transplant, and it seems that the patients that received the consolidation with the transplant did better than the patients who did not receive the transplant. You have the 3-year progression-free survival numbers: 76% and 53%, though my bias at this point would be young, relatively young, or with few comorbidities, good performance statusI would certainly send the patient to get a second opinion.

What would be your approach toward second-line therapy at progression?

The number 1 option is a clinical trial. Id also consider pralatrexate [Folotyn]. Belinostat [Beleodaq], pralatrexate, and romidepsin [Istodax] are going to give an overall response somewhere between 20% to 30%, and complete remissions that are approximately 10%, give or take. Duration of response is usually going to be less than a year. Bottom line, we need to do better for PTCL when its relapsed/refractory. We need to do good when it comes to our frontline therapies, so, hopefully, we can provide a long period of time of remission for our patients.

References:

1. Schmitz N, Trmper L, Ziepert M, et al. Treatment and prognosis of mature T-cell and NK-cell lymphoma: an analysis of patients with T-cell lymphoma treated in studies of the German high-grade non-Hodgkin lymphoma study group. Blood. 2010;116(18):3418- 3425. doi:10.1182/blood-2010-02-270785

2. NCCN. Clinical practice guidelines in oncology. T-cell lymphomas, version 1.2021. Accessed October 14, 2020. https://bit.ly/3kcUHLL

3. Horwitz S, OConnor OA, Pro B, et al; ECHELON-2 Study Group. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Lancet. 2019;393(10168):229-240. doi:10.1016/S0140-6736(18)32984-2

4. Connors JM, Jurczak W, Straus DJ; ECHELON-1 Study Group. Brentuximab vedotin with chemotherapy for stage III or IV hodgkins lymphoma. N Engl J Med. 2018;378(4):331-344. doi: 10.1056/NEJMoa1708984

5. Savage KJ, Horwitz SM, Advani RH. An exploratory analysis of brentuximab vedotin plus chp (A+CHP) in the frontline treatment of patients with CD30+ peripheral T-cell lymphomas (ECHELON-2): impact of consolidative stem cell transplant. Blood. 2019; 134(suppl 1):464. doi:10.1182/blood-2019-122781

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Exploring First-line Therapies in Peripheral T-Cell Lymphomas - Targeted Oncology

Israeli Scientists Discover Oxygen Beauty Treatment That Can Make You Look 25 Years Younger – All You Need to – India.com

Want to go back in time and look younger? Thats possible now. Yes, you read that right. In a path-breaking discovering, Israeli scientists have made reverse ageing possible. They have found a way to make you look up to 25 years younger. Also Read - Weight Lifting, Sleeping Face-Down And More: Here're 5 Lifestyle Habits That May be Ageing Your Skin

Researchers at Tel Aviv University and the Shamir Medical Centre have collaboratively conducted a study for which they enrolled 35 adults over 64. The subjects were given hyperbaric oxygen treatments (HBOT) 5 times a week for 90 minutes. This continued for three months. Later, the study results published in the journal Ageing showed that the use of this oxygen treatment shortened the ends of the chromosome (telomers) and reversed the accumulation of old body cells. Also Read - 3 Anti-Ageing Essential Oils That Can Offer You Youthful Skin

Notably, ageing depends upon sequences of DNA called telomeres. They are located at the ends of chromosomes and their function is to protect the genetic material contained within. These telomeres shorten and degrade every time a cell divides. This process keeps happening until they become so worn down that they can no longer function. This further results in an unstable or dead chromosome. Also Read - 5 Anti-Ageing Food Items You Must Include in Your Diet to Look Young

One of the study researchers named Professor Shai Efrati said, Today telomere shortening is considered the Holy Grail of the biology of ageing. Researchers around the world are trying to develop pharmacological and environmental interventions that enable telomere elongation. Our HBOT protocol was able to achieve this, proving that the ageing process can, in fact, be reversed at the basic cellular-molecular level.

Hyperbaric Oxygen Treatment (HBOT) is a type of therapy during which a patient is kept in a pressurized chamber where the level of oxygen is increased 3 to 4 times more than what you can breathe at normal air pressure. This aims at treating patients suffering from decompression sickness, brain abscess, severe anemia, who have developed air bubbles in their blood vessels, non-healing wounds, radiation injury, vision loss etc.

When your body gets extra oxygen, it releases growth factors and stem cells that are known to promote healing. In a normal scenario, the oxygen you get through the air is adequate for your body to perform different functions. However, when tissue in your body gets damaged or injured, it needs extra oxygen to survive. Through hyperbaric oxygen treatment, doctors temporarily increase the amount of blood your body is carrying and thus helps maintain the oxygen level in tissue to ensure its survival.

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Israeli Scientists Discover Oxygen Beauty Treatment That Can Make You Look 25 Years Younger - All You Need to - India.com

Novartis licenses phase 3 COVID-19 cell therapy from Mesoblast – FierceBiotech

Novartis has secured a global license to Mesoblasts cell therapy remestemcel-L in the treatment of COVID-19. The deal lands Mesoblast $50 million upfront and the support of a partner that could help address critical quality attribute concerns raised by the FDA.

Last month, the FDA rejected a filing for approval of the cell therapy in children with steroid-resistant graft-versus-host disease (GvHD). By then, Mesoblast had already begun testing the allogeneic cell therapy in COVID-19 patients with acute respiratory distress syndrome (ARDS). The phase 3 started in May is designed to validate signs of efficacy seen in a 12-patient compassionate use program.

Novartis has stepped in to help Mesoblast take remestemcel-L forward in ARDS. In return for a $25 million upfront payment and $25 million investment, plus milestones and royalties, Mesoblast has given Novartis a global license to develop and commercialize remestemcel-L in ARDS.

Evidence of the prospects of remestemcel-L, a mesenchymal stem cell therapy, in COVID-19-related ARDS is set to arrive when the 300-patient phase 3 trial wraps up early next year. If the trial is successful, Novartis plans to work with Mesoblast to develop appropriate critical quality attributes that meet [FDA] requirements for remestemcel-L.

The focus on critical quality attributes reflects the problems Mesoblast encountered when it tried to win FDA approval for remestemcel-L in GvHD earlier this year. In its briefing document, the FDA said the attributes do not have a demonstrated relationship to the clinical performance of specific [drug product] lots. The advisory committee backed the drug, but the FDA issued a complete response letter.

Novartis, which has an approved cell therapy, may have the expertise to ensure remestemcel-L fares better when up for review by the FDA as a treatment for ARDS in COVID-19 patients. Novartis will also provide support to enable commercial manufacturing scale-up. Mesoblast has previously said it needed to substantially scale up manufacturing to serve the COVID-19 market.

The relationship between the companies extends beyond COVID-19. Novartis plans to run a phase 3 trial in non-COVID-19 ARDS patients, setting it up to address the broader unmet medical need. ARDS causes 40% mortality in the around 200,000 patients who develop the condition in the U.S. annually.

Novartis also has an option to distribute remestemcel-L outside of Japan in GvHD and to co-fund its development and commercialization in other non-respiratory indications. Shares in Mesoblast rose 18% in response to the news. Even after the bump, the stock remains down on the highs it hit before the complete response letter.

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Novartis licenses phase 3 COVID-19 cell therapy from Mesoblast - FierceBiotech

Benefits of Hematopoietic Stem Cell Transplantation in Advanced Myelodysplastic Syndromes – Hematology Advisor

Among fit older adults with advanced myelodysplastic syndromes (MDS) undergoing hematopoietic stem cell transplantation (HSCT), survival is significantly improved when transplantation is performed early or for adverse risk disease but not for patients with standard risk disease with severe cytopenia, according to study results published in Leukemia.

For patients with MDS, the median age at the time of diagnosis is approximately 70 years, and patients typically have an overall survival of 1 year in advanced disease. Although the only known curative therapy is HSCT, the study authors noted that The median age at diagnosis has historically limited the number of patients considered eligible for [HSCT]. This is because of the increased mortality linked to myeloablative conditioning regimens in this patient population. However, reduced-intensity conditioning (RIC) has allowed HSCT to be a treatment option for fit, elderly patients.

Gregory A. Abel, MD, MPH, of Dana-Farber Cancer Institute and Harvard School of Public Health, in Boston, Massachusetts, and associates conducted a prospective observational study to assess survival among patients aged 60 to 75 years with advanced MDS who were eligible for HSCT, and to compare RIC HSCT vs non-HSCT approaches in this patient population. The primary endpoint was overall survival.

Of the 303 eligible participants, 290 patients were enrolled in the study; 175 patients had MDS and 115 had severe cytopenia. The median age of the entire cohort was 69 years and nearly two-thirds of the population were men (65.5%). The median overall survival for the entire group was 29 months (95% CI, 19-39.5), the 3-year overall survival was 46% (95% CI, 40-52).

A total of 113 patients underwent HSCT (median time to HSCT, 5 months). Of the patients who underwent transplantation, 58 patients (51.2%) died. Of the 177 patients who did not undergo HSCT, 119 patients (71.3%) died.

In a univariable analysis comparing death in HSCT with no HSCT, the hazard ratio (HR) was 0.84 (P =.30). The HR for death for HSCT 5 months or sooner after enrollment (HR, 0.64; P =.04) and more than 5 months after enrollment (HR, 1.20; P =.39) were also measured.

In a multivariable analysis controlling for several factors, the HR for mortality among patients who underwent HSCT vs no HSCT was 0.75 (P =.13), and the HRs for adverse MDS risk and standard risk with severe cytopenia were 0.57 (P =.01) and 1.33 (P =.36), respectively.

[F]it adults with advanced MDS, a treatment strategy that included [HSCT] trended toward better overall survival, the investigators noted. There were also significant benefits for those receiving [HSCT] within 5 months and for those with adverse disease risk factors as compared to standard risk with severe cytopenias. Future studies should refine which subgroups of adverse risk patients benefit most, how genomics and measurable residual disease can be used to risk stratify consideration of [HSCT] in this patient population, and how recently characterized predictors, such as frailty, may be incorporated into these decisions, the authors concluded.

Abel GA, Kim HT, Hantel A, et al. Fit older adults with advanced myelodysplastic syndromes: who is most likely to benefit from transplant? Leukemia. Published online November 17, 2020. doi:10.1038/s41375-020-01092-2

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Benefits of Hematopoietic Stem Cell Transplantation in Advanced Myelodysplastic Syndromes - Hematology Advisor

YOUR HEALTH: Your body may already have the answer to knee pain – WQAD.com

DENVER It impacts a lot of us.

One in four people are living with knee pain.

"I think it was just a matter of wear and tear of over the years," said Al Perez who has had knee pain for years.

"Walking became difficult because I get some swelling and pain."

Perez had his right knee replaced eight years ago and he didn't want a repeat procedure on his left.

"I have some arthritis in that knee, osteoarthritis, and I wanted to avoid at all costs another knee replacement."

Perez found orthopedic surgeon Dr. Jason Dragoo at the Steadman Hawkins Clinic at UCHealth in Denver who is part of a team that made stem-cell history.

"It set off this revolution worldwide of getting STEM cells from fat," said Dr. Dragoo

And now, he's using those stem cells to ease his patients knee pain.

"Mother nature put in this piece of fat that's in our knee, it's called the fat pad," said Dr. Dragoo.

"And we looked at the fat pad and it contains a very high number of STEM cells."

From harvesting the cells to implant, the procedure takes about 20 minutes.

"We process them in the operating room and then give them back to patients during the same surgical procedures."

Dr. Dragoo said the best candidate is someone with moderate to middle-stage arthritis.

Initial studies show that the treatment reduces pain and inflammation.

Now, they are looking to see if the cartilage regrows.

He's four years post-surgery and his pain is gone.

"Within three, four days I was walking with barely a limp," said Perez. "I was good. I can walk 18 holes."

Three places in the United States perform this procedure:

Studies have shown that stem cells release factors that reside on opioid receptors. Those are one of the pain-relieving receptors that we have in our body and that is the reason that stem cell therapy is thought to decrease pain.

If this story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Jim Mertens atjim.mertens@wqad.comor Marjorie Bekaert Thomas atmthomas@ivanhoe.com.

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YOUR HEALTH: Your body may already have the answer to knee pain - WQAD.com

Providing CAR T-Cell Therapy for Patients With DLBCL During COVID-19 – Targeted Oncology

Nilanjan Ghosh, MD, discusses the effect coronavirus disease 2019 had on using chimeric antigen receptor T-cell therapy to treat patients with diffuse large B-cell lymphoma.

Nilanjan Ghosh, MD, a hematologist and medical oncologist at the Levine Cancer Institute, Atrium Health, discusses the effect coronavirus disease 2019 (COVID-19) had on using chimeric antigen receptor (CAR) T-cell therapy to treat patients with diffuse large B-cell lymphoma (DLBCL).

Ghosh says that when the pandemic first started, he and other physicians thought it would not only affect CAR T-cell therapy but also stem cell transplants. CAR T-cell treatments for DLBCL include therapies such as axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah). There was a lot of uncertainty around how long the pandemic would last since it started abruptly with many acute cases, which filled intensive care units and hospital beds.

As the months went on, physicians adapted to treating patients during COVID-19, which Ghosh calls the new normal. As of October, the pandemic was not affecting the delivery of CAR T-cell therapy for clinical trials and treatment with standard of care in practices. At the beginning of COVID-19, he and his colleagues were doing their best to deliver standard-of-care CAR T therapy, but it did affect CAR T-cell delivery for clinical trials because of regulatory constraints. There were several months where accrual for these trials was limited, but over the past months, many of those constraints have been lifted and the clinical trials have opened back up.

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Providing CAR T-Cell Therapy for Patients With DLBCL During COVID-19 - Targeted Oncology

BioRestorative Therapies Emerges from Chapter 11 Reorganization – OrthoSpineNews

MELVILLE, N.Y., Nov. 20, 2020 (GLOBE NEWSWIRE) BioRestorative Therapies, Inc. (BioRestorative or the Company) (OTC: BRTX), a life sciences company focused on stem cell-based therapies, announced today that its amended joint plan of reorganization has become effective and it has emerged from Chapter 11 reorganization. Pursuant to the confirmed plan of reorganization, the Company has received $3,848,000 in financing. The confirmed plan of reorganization also provides for additional funding, subject to certain conditions, of $3,500,000 less the sum of the debtor-in-possession financing provided to the Company during the reorganization (approximately $1,227,000) and the costs incurred by the debtor-in-possession lender.

In connection with the reorganization, Lance Alstodt has been appointed the Companys President, Chief Executive Officer and Chairman of the Board. Mr. Alstodt said, This process has been a long and challenging journey for the Company. Im inspired by the great resolve and execution from our employees, professionals and investors. We are very pleased that all requirements have been met for us to emerge. Allowed creditor claims have been fully satisfied and, as importantly, our equity holders have retained their shares in this exciting new opportunity. We were able to preserve all of our intellectual property assets and look forward to initiating our Phase 2 clinical trial.

Based upon the Companys emergence from Chapter 11 reorganization, FINRA has removed the Q at the end of its trading symbol. Shareholders do not need to exchange their shares for new shares.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate,BRTX-100,is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders. TheBRTX-100production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure,BRTX-100is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial usingBRTX-100to treat persistent lower back pain due to painful degenerative discs.

Metabolic Program (ThermoStem): We are developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

Forward-Looking Statements

This press release containsforward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Companys latest Form 10-K filedwith the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT: Email: ir@biorestorative.com

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BioRestorative Therapies Emerges from Chapter 11 Reorganization - OrthoSpineNews