On January 24, 2023 CTI BioPharma Corp. (NASDAQ: CTIC) reported that an authorized subcommittee of the Compensation Committee of its Board of Directors granted an equity award to a new employee as an equity inducement award outside of the Company’s Amended and Restated 2017 Equity Incentive Plan (but under the terms of the Amended and Restated 2017 Equity Incentive Plan) and material to the employee’s acceptance of employment with the company (Press release, CTI BioPharma, JAN 24, 2023, View Source [SID1234626510]). The equity award was approved on January 23, 2023, in accordance with Nasdaq Listing Rule 5635(c)(4).

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The employee received options to purchase 22,000 shares of CTI BioPharma common stock. The options will be issued upon the employee’s grant date (the "Grant Date"), and all stock options included within the equity inducement award will have an exercise price equal to the closing price of CTI BioPharma common stock on the Grant Date. One-fourth of the options will vest on each anniversary of the employee’s Grant Date, subject to the employee’s continued employment with CTI BioPharma on such vesting dates. The options have a ten-year term.

On January 24, 2023 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported positive interim data from Part A of the ongoing RAMP 201 (ENGOTov60/GOG3052) international registration-directed Phase 2 study evaluating the safety and efficacy of avutometinib (VS-6766) alone and in combination with defactinib among patients with recurrent low-grade serous ovarian cancer (LGSOC) (Press release, Verastem, JAN 24, 2023, View Source [SID1234626509]). The Company is also providing a regulatory update following a productive meeting with the U.S. Food and Drug Administration (FDA).

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"The interim data from the ongoing phase 2 RAMP 201 trial show that the combination of avutometinib with defactinib yields encouraging response rates with a well-tolerated safety profile in women with heavily pre-treated recurrent low-grade serous ovarian cancer," said Dr. Susana Banerjee, MBBS, MA, PhD, FRCP, global lead investigator of the study, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust and Team Leader in Women’s Cancers at The Institute of Cancer Research, London. "The contribution of defactinib, rates of tumor shrinkage in both KRAS mutant and KRAS wild-type LGSOC and a high disease control rate seen so far are important initial findings leading to the decision to move forward with the combination regimen. We look forward to the final analysis."

Results of RAMP 201 Part A Interim Analysis

The objective of Part A (selection phase) of the RAMP 201 LGSOC study was to select the go forward regimen between avutometinib monotherapy or the combination of avutometinib and defactinib to be studied in Part B (expansion phase) of the study. In addition, the efficacy was assessed in both KRAS mutant and KRAS wild type LGSOC. Part A randomized eligible patients to avutometinib monotherapy (n=33) or the combination of avutometinib and defactinib (n=31). The combination of avutometinib and defactinib has been declared the go forward treatment regimen based on a higher rate of confirmed objective responses in a planned interim analysis with prespecified criteria.

Overall, patients on the combination arm were heavily pretreated with an average of 4 prior systemic regimens (up to 11), including prior platinum-based chemotherapy, endocrine therapy and bevacizumab in most patients and prior MEK inhibitor therapy in about 20% of patients.

Of the 29 patients evaluable for response by blinded independent central review (BICR) in the combination arm, the initial results showed a confirmed objective response rate (ORR) of 28% in all patients and 27% vs 29% in KRAS mutant (n=15) and KRAS wild-type (n=14) LGSOC, respectively. Three additional patients with KRAS mutant LGSOC showed an unconfirmed partial response. In addition, the vast majority of patients showed tumor regression, as the overall disease control rate (stable disease plus partial response) was 93%. Most evaluable patients (62%) were still on study treatment on the combination arm at the time of the data cut with a minimum follow-up of 5 months.

The confirmed ORR for the monotherapy arm by BICR was 7% in evaluable patients (n=30). The overall disease control rate for the monotherapy arm by BICR was 90%.

Across both the combination and monotherapy arms, there have been no additional safety signals reported with a continued favorable safety and tolerability profile. The most common treatment-related adverse events for the combination in all treated patients were diarrhea, nausea, blood creatine phosphokinase (CPK) increased, vision blurred, dermatitis acneiform and rash, fatigue and peripheral edema, most of which were mild to moderate, with 9% discontinuation due to adverse events.

"LGSOC is a difficult disease to treat and one in urgent need of more effective and tolerable therapies. The majority of patients with LGSOC present with advanced stage disease and experience chronic symptoms from their cancer. Prior studies have shown disappointing response rates with conventional chemotherapy or hormonal therapy and there are currently no agents that are FDA approved specifically for the treatment of this cancer," said Rachel N. Grisham, M.D., Section Head, Ovarian Cancer and Director, Westchester Gynecologic Medical Oncology at Memorial Sloan Kettering Cancer Center NY, and the study’s principal US investigator. "The interim positive data from RAMP 201 are encouraging and indicate the combination of avutometinib and defactinib remains a promising approach for treating patients with recurrent LGSOC."

Target enrollment for the combination arm in RAMP 201 has been achieved. The Company is planning a RAMP 201 presentation at a scientific conference in mid-2023.

Regulatory Update Following Type B FDA Meeting on LGSOC Program

A recent FDA meeting was held to discuss the encouraging results to date of the ongoing RAMP 201 trial evaluating avutometinib ± defactinib among patients with recurrent LGSOC, confirm the go forward treatment regimen selection and discuss the regulatory path forward. The combination of avutometinib with defactinib has been selected vs monotherapy as the go forward treatment in all recurrent LGSOC regardless of KRAS status, acknowledging the demonstrated contribution of defactinib.

The Company intends to include mature data from RAMP 201, the Verastem sponsored clinical trial, and the FRAME study, led by The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust to potentially support filing for accelerated approval. Both studies are evaluating avutometinib and defactinib in patients with recurrent LGSOC. The Company is in ongoing discussions with the FDA on the confirmatory study and plans to provide an update after agreement with the FDA. Continued enrollment in the combination arm of RAMP 201 is planned to expand the clinical experience in anticipation of initiation of a confirmatory study.

"We appreciate the productive and ongoing discussions with the FDA regarding the progress of our LGSOC program, including the alignment around key next steps as part of our breakthrough therapy designation," said Brian Stuglik, CEO of Verastem Oncology. "With the encouraging results of the RAMP 201 Part A interim analysis and the FRAME study, we will work expeditiously to prepare to file for an accelerated approval that encompasses the totality of the data from both trials as well as progress on the confirmatory study."

Conference Call, Presentation and Webcast Information

The Verastem Oncology management team will host a conference call and webcast today, Tuesday, January 24, 2023, at 6:00 PM ET. The conference call can be accessed by clicking here. The webcast of the conference call and accompanying slides can also be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

Dr. Banerjee and Dr. Grisham have consulting relationships with Verastem Oncology.

About Avutometinib (VS-6766)

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. Avutometinib is currently in late-stage development.

In contrast to other MEK inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is currently conducting clinical trials with its RAF/MEK clamp avutometinib in RAS-driven tumors as part of its (Raf And Mek Program). RAMP 201 is a registration-directed trial of avutometinib alone and in combination with defactinib in patients with recurrent LGSOC. Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and KRAZATI (adagrasib) in combination with avutometinib in KRAS G12C mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively. As part of the "Therapeutic Accelerator Award" Verastem Oncology received from PanCAN, the Company is conducting RAMP 205, a Phase 1b/2 clinical trial evaluating avutometinib and defactinib with gemcitabine/nab-paclitaxel in patients with front-line metastatic pancreatic cancer.

About Low-Grade Serous Ovarian Cancer (LGSOC)

LGSOC is a highly recurrent, chemotherapy-resistant cancer, associated with slow tumor growth and high mortality rate. Approximately 6,000 women in the U.S. and 80,000 worldwide are living with this disease. Mutations in the KRAS gene are present in 30% of cases of LGSOC. LGSOC is most often diagnosed in women between the ages of 45-55 years and has a median survival of approximately ten years. The majority of patients experience severe pain and complications as the disease progresses. Chemotherapy is the standard of care for this disease, with limited treatment options currently available.

About RAMP 201

Verastem Oncology has initiated a Phase 2 registration-directed trial evaluating avutometinib alone and in combination with defactinib in patients with recurrent LGSOC as part of RAMP (Raf And Mek Program). RAMP 201 (ENGOTov60/GOG3052) is an international collaboration between the European Network of Gynaecological Oncological Trial groups (ENGOT) and the Gynecologic Oncology Group (GOG) and sponsored by Verastem Oncology. It is an adaptive, two-part multicenter, parallel cohort, randomized, open-label trial to evaluate the efficacy and safety of avutometinib alone and in combination with defactinib in patients with recurrent LGSOC. The first part of the study will determine the optimal regimen of either avutometinib monotherapy or in combination with defactinib in patients with recurrent LGSOC randomized 1:1 in each treatment arm. The determination of which regimen to take forward into the expansion phase of the trial will be made based on objective response rate data. The expansion phase of the study will examine efficacy and safety parameters of the regimen selected.

On January 24, 2023 Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that it has entered into a definitive agreement to sell approximately 2.1 million shares of its Series B Convertible Preferred Stock (the "Preferred Stock") to affiliates of BVF Partners L.P. in a private placement to raise aggregate gross proceeds of up to approximately $60 million in two tranches, before deducting fees to the placement agent and other estimated offering expenses payable by the Company (Press release, Verastem, JAN 24, 2023, View Source [SID1234626508]). The initial tranche, consisting of 1.2 million shares of Preferred Stock for gross proceeds of approximately $30 million, representing a purchase price per common share equal to $0.5901, is anticipated to close on January 27, 2023, subject to the satisfaction of customary closing conditions. The second tranche, consisting of 0.9 million shares of Preferred Stock for gross proceeds of approximately $30 million, resulting in a purchase price per common share equal to $0.75, will close within seven trading days of the Company’s common stock trading for a 10-day volume weighted average price of at least $1.125 per share with aggregate trading volume during the same 10-day period of at least $25 million within 18 months from the closing date of the initial tranche.

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Truist Securities acted as sole placement agent for the private placement.

The shares of Preferred Stock are convertible into the Company’s common stock, par value $0.0001 per share (the "Common Stock"), at the option of the holders at any time, subject to certain limitations, at a conversion rate equal to $0.5901 per share, a premium above the 5 day average closing price of $0.5860 as of January 24, 2023. The holders will initially be prohibited from converting Preferred Stock into Common Stock if, as a result of such conversion, any holder, together with its affiliates, would beneficially own 9.99% or more of the total Common Stock then issued and outstanding immediately following the conversion of such shares of Preferred Stock.

Shares of Preferred Stock will have no voting rights, except as required by law and except that the consent of a majority of the holders of the outstanding Preferred Stock will be required to amend the terms of the Preferred Stock. In the event of the Company’s liquidation, dissolution or winding up, holders of Preferred Stock are entitled to receive, in preference to any distributions of any of the assets or surplus funds of the Company to the holders of the Common Stock, an amount equal to $1.00 per share of Preferred Stock ("Liquidation Preference"). After payment of the Liquidation Preference, each holder of shares of Preferred Stock shall be entitled to participate pari passu with the holders of the Common Stock on an as-converted basis. Holders of Preferred Stock are entitled to receive when, as and if dividends are declared and paid on the Common Stock, an equivalent dividend, calculated on an as-converted basis. Shares of Preferred Stock are otherwise not entitled to dividends.

The Preferred Stock ranks (i) senior to all of the Common Stock; (ii) senior to all other classes and series of equity securities of the Corporation that by their terms do not rank senior to the Preferred Stock; (iii) senior to all shares of the Company’s Series A Convertible Preferred Stock; (iv) on parity with any class or series of capital stock of the Company hereafter created specifically ranking by its terms on parity with the Preferred Stock; (v) junior to any class or series of capital stock of the Company hereafter created specifically ranking by its terms senior to any Preferred Stock; and (vi) junior to all of the Company’s existing and future debt obligations.

Verastem intends to use the net proceeds from the private placement for general corporate purposes, which may include working capital, capital expenditures, research and development expenditures, clinical trial expenditures, commercial expenditures, milestone payments under in-license agreements, and possible acquisitions.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended ("Securities Act"), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the Preferred Stock and the shares of Common Stock issuable upon the conversion of the Preferred Stock issued in the private placement no later than the 10th day after the filing of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.

On January 24, 2023 Precigen, Inc. (Nasdaq: PGEN) reported it has commenced an underwritten public offering of $75.0 million of its common stock (Press release, Precigen, JAN 24, 2023, View Source [SID1234626507]). In addition, Precigen intends to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the size or terms of the offering. All of the shares in the proposed offering are to be sold by Precigen.

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J.P. Morgan Securities LLC is acting as the lead book-running manager for the offering. Cantor Fitzgerald & Co. is also acting as book-running manager. JMP Securities, a Citizens company, is acting as lead manager and H.C. Wainwright & Co., LLC is acting as co-manager.

The public offering will be made pursuant to a shelf registration statement on Form S-3 that was previously filed with the Securities and Exchange Commission (SEC) and became effective on July 2, 2020. A preliminary prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and will be on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and base prospectus relating to this offering may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, telephone: 1-866-803-9204, or by emailing at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 24, 2023 Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) that is developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, reported entry into a sponsored research agreement with Stanford School of Medicine and the appointment of Frederick M. Dirbas, MD, Associate Professor of Surgery, Division of Surgical Oncology, Stanford School of Medicine and Mark D. Pegram, MD, the Suzy Yuan-Huey Hung Endowed Professor of Medical Oncology at the Stanford School of Medicine to the Beyond Cancer Scientific Advisory Board (SAB) (Press release, Beyond Cancer, JAN 24, 2023, View Source [SID1234626505]). In addition to the research agreement, Dr. Dirbas will serve as Chair of the SAB, which provides guidance for ongoing preclinical studies as well as ongoing and planned future clinical trials in the use of UNO to treat solid tumors. The newly appointed members of the SAB will work to provide input on the clinical development of Beyond Cancer’s UNO technology particularly as it relates to the U.S. regulatory submission. The Company expects the protocols for its clinical program to be influenced by the preclinical data and the Phase 1 clinical trial experience.

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"I am excited to have these two accomplished oncologists join the Beyond Cancer Scientific Advisory Board," stated Dr. Selena Chaisson, Chief Executive Officer of Beyond Cancer. "The goal of the SAB will be to provide us with the best possible resources from experts around the world. Their input will help determine whether UNO may provide a superior efficacy and/or safety profile than current treatment options. We have high expectations for UNO as a potential new paradigm for treating patients with cancer."

These two expert academic clinicians have made important discoveries throughout their careers that have had outsized impacts on cancer care. As an investigator, Dr. Dirbas in 2002 was an early adopter of accelerated, partial breast irradiation for surgical patients with early-stage breast cancer and served as Primary Investigator (PI) on Stanford’s successful investigator initiated APBI trial: he has also served as site-PI for other cooperative group trials related to breast cancer. From 2010 to 2017 he was the leader of Stanford Cancer Center’s Breast Clinical Care Program during which time the program grew considerably in national recognition. For the last two decades, Dr. Dirbas has served as a co-investigator studying subtypes of breast cancer stem cells in triple negative breast cancer. Currently, he is the PI on studies in the application of FLASH radiotherapy in breast cancer (recently presented at the San Antonio Breast Cancer Symposium).

Dr. Pegram played a significant role in the pre-clinical and clinical development of trastuzumab (Herceptin) for the treatment of HER2-positive breast cancer. He was lead author on the papers describing pre-clinical synergy between multiple chemotherapeutics and trastuzumab, and the first phase II clinical trial of trastuzumab plus chemotherapy. In addition, he was the senior author of the pivotal trial of letrozole plus lapatinib – leading to an FDA approval. In addition, Dr. Pegram was the co-author of the pivotal trials of trastuzumab plus chemotherapy, and T-DM1, both published in the New England Journal of Medicine, and lead to FDA approvals.

"I am pleased to be appointed Chair of the Beyond Cancer Scientific Advisory Board," said Dr. Dirbas. "Dr. Pegram and I look forward to providing guidance to the team at Beyond Cancer on their preclinical and clinical studies as they work to translate UNO into a potential treatment option for patients with solid tumors."

Scientific Advisory Board Member Biographies

Frederick Dirbas, MD

Dr. Dirbas is a graduate of Stanford University and the Columbia University College of Physicians and Surgeons (now the Vagelos College of Physicians and Surgeons). He completed his surgical residency at Stanford University School of Medicine during which time he spent two years at the NIH/NHLBI/NCI as a clinical research fellow studying the use of immunotherapy to prevent rejection of cardiac transplants. Subsequently, he completed a surgical oncology fellowship at Stanford with John Niederhuber, MD.

Dr. Dirbas has served as a member of Stanford’s Scientific Review Committee and on study sections for the Susan Komen Foundation and the Department of Defense. Dr. Dirbas has published nearly 50 articles in peer-reviewed journals such as Journal of the National Comprehensive Cancer Network, Journal of the National Cancer Institute, and Cancer Biotherapy and Radiopharmaceuticals. As co-author, Dr. Dirbas has contributed to publications in Cancer Cell, Annals of Surgical Oncology, Science, Nature Communications, among other peer-reviewed journals. He was lead co-editor of an 86-chapter, multidisciplinary textbook on breast cancer published in 2011 that included authors from Stanford, Memorial Sloan Kettering, Dana Farber, the Mayo Clinic, MD Anderson, and other prominent cancer centers: over 200K chapters have been downloaded from the book electronically. He received the Silicon Valley Wellness Foundation’s Star Caregiver Award in 2008 and has been repeatedly named by Castle Connolly and other groups among the best doctors in America.

Initially, Dr. Dirbas was a critical care attending at the Palo Alto VA and a trauma surgeon when Stanford achieved recognition as a Level I Trauma Center in 1998. Since that time, Dr. Dirbas has maintained a highly respected clinical practice in breast surgical oncology. Most recently Dr. Dirbas joined Frontiers in Cell and Developmental Biology as a Review Editor. His research interests are focused on developing novel, paradigm shifting treatments for breast cancer and other solid tumors.

Mark Pegram, MD

Dr. Pegram is the Suzy Yuan-Huey Hung Endowed Professor of Medical Oncology at the Stanford University School of Medicine and currently serves as the Associate Dean for Clinical Research Quality at the Stanford University School of Medicine and is the Medical Director of the Stanford Clinical Translational Research Unit – a unit specializing in first-in-human phase I clinical trials.

Dr Pegram received his medical degree from the University of North Carolina at Chapel Hill. He went on to complete an internship and residency at the University of Texas Southwestern Medical Center in Dallas. He concluded his training with a fellowship at the UCLA David Geffen School of Medicine in Los Angeles, CA.

Dr Pegram’s breast cancer research is focused on the study of the cancer-associated gene that encodes HER2 and on the development of novel agents in the treatment of patients with HER2-positive metastatic breast cancer. He has authored more than 125 publications in medical oncology, hematology, and biosimilars across different cancer types.

Sunil Panchal, MD

Dr. Panchal is a minimally invasive spine and interventional pain specialist actively involved in the development of novel analgesics, neurostimulation devices, and surgical techniques as well as clinical research protocol designs. He currently serves as the President of the National Institute of Spine and Pain and is an invited editorial reviewer for Clinical Researcher, Anesthesia and Analgesia, Pain, Pain Medicine, and the Clinical Journal of Pain. Dr. Panchal joined the Beyond Cancer Scientific Advisory Board in December 2021.

Dr. Panchal was previously an Associate Professor in the Departments of Oncology and Anesthesiology and Director of Interventional Pain Medicine at the H. Lee Moffitt Cancer Center and Research Institute of the University of South Florida College of Medicine in Tampa, Florida. He also served as Co-Director of the Chronic Pain Service as well as Director of the Multidisciplinary Pain Fellowship Training Program at Johns Hopkins University with a joint appointment in Oncology, then subsequently served as Co-Director of the Chronic Pain Service as well as Director, Division of Pain Medicine at the Joan and Sanford I. Weill Medical College of Cornell University in New York. Dr. Panchal also served as the Chair of the National Comprehensive Cancer Network Cancer Pain Panel and has lectured widely at the national and international level.

Dr Panchal received his medical degree from Albany Medical College of Union University in Albany, New York and completed a residency in anesthesiology at Northwestern University in Chicago, Illinois. Following his residency, Dr. Panchal completed a fellowship in pain management at the University of Illinois in Chicago and a Business of Medicine Graduate Program at Johns Hopkins University in Baltimore, Maryland.

About Nitric Oxide

Nitric Oxide is a powerful molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.