On May 19, 2016 Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT, www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company ("Provectus" or "the Company"), reported the availability of an abstract titled "A phase 2 study of intralesional PV-10 followed by radiotherapy for localized in transit or recurrent metastatic melanoma" that has been published in conjunction with the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") being held in Chicago June 3-7, 2016.

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To see this abstract, visit: View Source

The abstract, ID: e21072, was published May 18, 2016, and is authored by Matthew Foote and colleagues at the Princess Alexandra Hospital and University of Queensland, in Brisbane, Australia.

Eric Wachter, Ph.D., Chief Technology Officer of Provectus, noted, "This abstract describes initial analysis of data from an investigator-initiated study of PV-10 followed by regional radiotherapy for refractory melanoma. Patients received a single course of PV-10, and if not immediately achieving a complete response they received a modest dose of radiation 6-10 weeks later. This combination yielded an 87% response rate with a third of patients achieving complete response. The response was durable (12.2 months mean duration of complete response), however, the protocol did not allow for subsequent retreatment, and the authors report that 80% of patients eventually had recurrence. Nonetheless, the melanoma specific survival of almost 5 and a half years is encouraging, and I agree with the authors’ conclusion that these results justify expanded evaluation in a randomized trial."

Wachter continued, "This work arose from observations by these same researchers several years ago that, as they stated at the time, melanoma patients treated with PV-10 followed by external beam radiotherapy ‘had an impressive response.’ Also as observed in those early cases, the data reported in this ASCO (Free ASCO Whitepaper) abstract show that there appears to be minimal potential for increased side effects when PV-10 is used in combination with radiotherapy."

Wachter concluded, "The primary purpose of presenting research data at international meetings such as ASCO (Free ASCO Whitepaper) is to share knowledge within the medical community. An important implication of this is fostering dialog within the community regarding appropriate use of such data. In this case, I hope this initial report will help foster relationships that facilitate advancement of these findings into advanced studies, as suggested by the authors."

On April 16, 2018 Abpro, an integrated life science company at the forefront of synthetic biology, reported co-development agreements with Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH), two of the country’s leading academic medical centers (Press release, abpro therapeutics, MAY 19, 2016, View Source [SID1234525613]). By leveraging Abpro’s DiversImmune platform, Abpro will co-develop multiple monoclonal antibodies with MGH for use in its oncology and inflammation and autoimmunity research programs and with BWH for its fibrosis research, according to these independent and separate agreements.

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With MGH, Abpro will collaborate with John H. Stone, MD, MPH, Director of Clinical Rheumatology and Professor of Medicine, Harvard Medical School, and Shiv Pillai, MD, PhD, Associate Geneticist, Center for Cancer Research and Professor of Medicine, Harvard Medical School, for both fibrosis and oncology. Dr. Stone’s work focuses on vasculitis, a group of inflammatory diseases that target blood vessels. His team has identified a novel T lymphocyte that may drive the intractable condition of fibrosis across an array of human diseases. At the Pillai Lab, one of the pathways being studied suggests new approaches for the treatment of autoimmune disorders. Dr. Pillai and his colleagues have discovered novel ways to strengthen immune responses and enhance helper T cell memory that provides hope for developing more effective personalized immune-system based treatments for cancer.

"I look forward to leveraging Abpro’s platform to develop antibodies for targets that traditionally, have been difficult to target," said Dr. Shiv Pillai, who also is a member of Abpro’s Scientific Advisory Board. "I have been familiar with Abpro’s unique approach, and we are looking forward to working with it in our lab."

With BWH, Abpro will work with Michael B. Brenner, MD, Theodore B. Bayles Professor of Medicine Chief, Division of Rheumatology, Immunology and Allergy, Brigham and Women’s Hospital, in the areas of inflammation and autoimmunity. In addition to the full development of basic research in areas relevant to rheumatic and allergic diseases, translational research and clinical research at the population level and patient therapeutics, the division has also organized and integrated much of its research to provide interdisciplinary progress in several key human diseases.

According to these co-development agreements, MGH and BWH will work with Abpro towards the development of new therapeutic antibodies using Abpro’s Diversimmune platform, which is designed to generate antibodies with high sensitivity and specificity for advancing human health.

Abpro’s products and discovery services are used by leading academic labs and companies around the world for life science research purposes, such as therapeutics, diagnostics and research products. Abpro has formed multiple partnerships around novel biomolecules with leading biotechnology and international pharmaceutical companies including Amgen, Eli Lilly, Genzyme, MedImmune, Merck, Novartis, Pfizer, and others. In addition, Abpro has collaborated with several academic research centers, including Harvard University, Massachusetts Institute of Technology and Stanford University.

On May 19, 2016 Guided Therapeutics, Inc. (OTCQB:GTHP) reported its operating results for the first quarter ended March 31, 2016 (Press release, Guided Therapeutics, MAY 19, 2016, View Source [SID:1234512610]).

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Sales Revenue, Cost of Sales and Gross Profit (Loss) from Devices and Disposables: Sales revenue from the sale of LuViva devices and disposables for the three months ended March 31, 2016, was $262,000, a 106% increase compared to the same period in 2015. Related costs of sales and net realizable value expenses were approximately $68,000, which resulted in a gross profit of approximately $194,000 for the first quarter of 2016. For the same period in 2015, approximately $127,000 in sales revenue was offset by approximately $107,000 in related costs of sales, resulting in a gross loss on devices and disposables of approximately $20,000. The increase from gross loss to gross profit was due to increased sales of disposables with the Company’s primary distributor, which carry a higher profit margin than device sales.

Research and Development Expenses: Research and development expenses decreased to approximately $290,000 for the three months ended March 31, 2016, compared to $373,000 for the same period in 2015. The decrease, of approximately $83,000, was primarily due to a slight decrease in payroll expenses.

Sales and Marketing Expenses: Sales and marketing expenses were approximately $117,000 during the three months ended March 31, 2016, compared to $172,000 for the same period in 2015. The decrease was primarily due to Company-wide expense reduction and cost savings efforts.

General and Administrative Expenses: General and administrative expenses decreased to approximately $917,000 during the three months ended March 31, 2016, compared to approximately $963,000 for the same period in 2015. The decrease of approximately $46,000, or 5.0%, was primarily related to lower compensation and option expenses incurred during the same period.

Other Income: Other income for the three months ended March 31, 2016, was approximately $23,000, compared to other income of approximately $21,000 for the three months ended March 31, 2015.

Interest Expense: Interest expense decreased to approximately $158,000 for the three months ended March 31, 2016, as compared to approximately $492,000 for the same period in 2015, primarily due to amortization of debt discount and debt issuance costs that were higher for the same period in 2015.

Fair Value of Warrants Expense: Fair value of warrants expense recovery was approximately $1,395,000 for the three months ended March 31, 2016, as compared to approximately $714,000 for the same period in 2015.

Net income was approximately $130,000 during the three months ended March 31, 2016, compared to a net loss of $1,245,000 for the same period in 2015, for the reasons outlined above. Preferred stock dividends was approximately $470,000 during the three months ended March 31, 2016, compared to $31,000 for the same period in 2015. Basic Net loss per share, was $0.11 for the three months ended March 31, 2016, and $1.31 for the same period in 2015. Diluted Net loss per share, was $0.00 for the three months ended March 31, 2016, and $1.31 for the same period in 2015.

Cash on hand at March 31, 2016, was approximately $56,000, as compared to approximately $35,000 at December 31, 2015. Net inventory on hand at the end of the quarter was approximately $1.3 million. The Company continues to manage cash and liquidity with austerity.

"The first quarter was a record for shipping single-use disposable LuViva cervical guides with almost 24,000 going to our Turkish distributor," said Gene Cartwright, Chief Executive Officer of Guided Therapeutics. "We also shipped LuViva devices to Saudi Arabia and Indonesia during the quarter, bringing to 10 the number of units in the Middle East and 15 in Southeast Asia. As of the end of the first quarter, we shipped a total of 97 LuViva devices and approximately 60,000 disposable cervical guides, worldwide."

"During the first quarter, we received notification that the Health Services Sector of Nairobi County, Kenya, has agreed to purchase an additional five LuViva units for use in the agency’s cervical cancer screening program. The planned purchase brings to six the number of LuVivas ordered by Nairobi County, which is the largest population center in East Africa with approximately 900,000 screening-aged women," Mr. Cartwright said.

"Finally, we expanded our distribution in Latin America to include the Dominican Republic in the first quarter and subsequently shipped our first unit there," Mr. Cartwright said. "We continue to negotiate with potential partners for distribution and manufacturing rights in China, and are in late stage discussions with a partner for India."

On May 19, 2016 Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, reported that several abstracts on the Company’s gene expression profile (GEP) tests for cancer were accepted for poster presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from June 3-
7 (Press release, Castle Biosciences, MAY 19, 2016, View Source [SID:1234512611]). Included in the presentations are results from a new multicenter performance study of cutaneous melanoma tumors from 334 patients, confirming the positive results from the two previously published multicenter clinical validation studies,
and a new multicenter decision impact study of the DecisionDx-Melanoma test.

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Multicenter Performance Study in Cutaneous Melanoma: In a study, titled "Performance of a 31-Gene Expression Profile in a Previously Unreported Cohort of 334 Cutaneous Melanoma Patients" (Abstract # 9581), 334 cutaneous melanoma tumors from 12 centers in the U.S. were analyzed using the DecisionDx-Melanoma gene expression profile (GEP) test. Tumors were classified as low-risk Class 1 or high-risk Class 2. The Class status was compared to traditional methods for predicting distant metastasis at diagnosis.

Summary of Results:

Cox univariate regression analysis of the cohort indicated that Breslow’s thickness, ulceration, mitotic rate, sentinel lymph node (SLN) status and results of the GEP test were significant predictors of distant metastasis risk (p<0.008 for all; median Breslow’s thickness = 1.5 mm, median follow up = 5.3 years); However, only the GEP test (p=0.031) and SLN status (p= 0.002) were shown to be independent predictors of distant metastasis (Cox multivariate regression analysis); 13 of 83 (16%) SLN negative cases had a distant metastatic event; 10 (77%) of these cases were predicted to be high-risk (Class 2 result) by the GEP test;
Accuracy of distant metastasis risk prediction by the GEP test showed 76% sensitivity, 55% specificity, 42% positive predictive value and 85% negative predictive value, compared to 72%, 64%, 45% and 84%, respectively, for SLN
status.

"The results from this multicenter performance study confirm the accuracy of the
test in predicting metastasis as documented in previously published clinical
validation studies of DecisionDx-Melanoma," commented Federico A. Monzon,
M.D., FCAP, Chief Medical Officer of Castle Biosciences. "Our test complements
traditional staging tools to better identify patients at risk for recurrence, enabling
implementation of follow-up plans that are consistent with a patient’s individual
risk of recurrence."

Independent, Prospective Study in Cutaneous Melanoma:
Also at the meeting, a study titled "Prospective Validation of Gene Expression
Profiling in Primary Cutaneous Melanoma" (Abstract #9565), will be presented
from a prospectively designed and conducted study of 174 melanoma patients
undergoing sentinel lymph node biopsy (SLNB) and testing with the DecisionDx-
Melanoma GEP test. The data show that GEP classification is significantly
associated with early recurrence in patients diagnosed with melanoma.

In the study, 174 melanoma patients undergoing SLNB also underwent GEP
testing of their primary tumor at the time of the initial evaluation. The GEP test
result was reported as Class 1 low-risk or Class 2 high-risk of metastasis, or
insufficient tumor sample (INS). Median follow-up was 12 months.

Summary of Results:

Analysis was conducted on 159 patients with GEP test results:
Gender (p=0.008), Breslow’s thickness (<0.0001), ulceration (<0.0001), SLN positivity (=0.01) and Disease-Free Survival (<0.0001) were significantly associated with GEP test classification;
SLN was positive for 20 patients (13%) and negative for 139 patients
(87%):
Seven (35%) of 20 SLN positive patients and seven (5%) of 139
SLN negative recurred within 2 years;
GEP test results: 42 were high-risk Class 2 and 117 patients were low-risk
Class 1;
13 (31%) of the 42 Class 2 patients, and one (<1%) of the 117 Class 1 patients recurred within 2 years;
Of 10 patients with both a Class 2 GEP status and positive SLN, seven
(70%) recurred.
Multicenter, Decision Impact Study in Cutaneous Melanoma:
A third abstract related to cutaneous melanoma entitled, "Impact of Prognostic
Genomic Classification of Melanoma with a 31-Gene Expression Profile on
Clinical Decision-Making in a Retrospective Cohort" (Abstract #e21066), was
accepted for publication at the meeting.
In this study, medical records of cutaneous melanoma patients consecutively tested with DecisionDx-Melanoma at 6 medical practices from May 2013 to September 2015, were reviewed under an IRB-approved protocol. Investigators
reported clinical management plans included frequency of visits, frequency and modality of imaging, use of laboratory tests and specialty referrals. Clinical
management plans before and after receipt of the DecisionDx-Melanoma test results were collected to assess the impact on clinical decision making. Results
showed that the GEP test outcome changed clinical management for over half of the tested patients.

Summary of Results:

153 cutaneous melanoma patients met inclusion criteria with complete AJCC staging and management information:
44% were Stage I, 50% Stage II, and 6% Stage III;
61% (94) had low-risk Class 1 GEP test results and 39% (59) had high-risk Class 2;
Test results prompted a change in clinical management in 52% of patients:
78% of Class 2 and 36% of Class 1 patients had management changes (p<0.0001);
Of the 80 cases with observed changes in management, 95% (76) were adjusted in a manner consistent with DecisionDx-Melanoma Class prediction (higher intensity management in Class 2 patients versus lower intensity management in Class 1 patients);
Association between GEP test class and change in management intensity was statistically significant (p< 0.0001).
"The DecisionDx-Melanoma test has now been evaluated in clinical studies that included more than 900 melanoma patient cases, with more than 400 in independent, prospectively designed trials," commented Derek Maetzold, President and CEO of Castle Biosciences. "Each study showed a consistent, high rate of accuracy and clinical utility. These new results and the high negative predictive value rates for melanoma-specific survival observed across the DecisionDx-Melanoma studies give physicians and patients comfort when following a disease management plan based on results of staging and our GEP test."

Development Study in Soft Tissue Sarcoma:
Also at the meeting, in a study called "Metastasis Risk Prediction in Non-Translocation Soft tissue Sarcoma with a Novel Gene Expression Profile Assay" (Abstract #11055), investigators will present data from a new test developed by Castle Biosciences to assess the risk of cancer recurrence in patients diagnosed with soft tissue sarcomas (STS). Results showed that the STS-profile assay was able to distinguish two groups with significantly different metastatic risk.

About Melanoma
Cutaneous melanoma is diagnosed in approximately 76,000 people in the U.S.
each year, according to the American Cancer Society. Seventy-five percent are
diagnosed as Stage I or II, meaning there is no evidence of the melanoma
spreading beyond the primary tumor. It is not the most prevalent form of skin
cancer, but it is the most aggressive. Unlike other more common skin
malignancies such as basal cell and squamous cell carcinomas, melanoma often
spreads to other parts of the body, either via the lymphatic or blood system,
resulting in cancers of distant organs including the brain or lungs. So, while it
represents just 4% of skin cancers, melanoma accounts for about 80% of skin
cancer-related deaths.

About Soft Tissue Sarcoma
Soft tissue sarcoma is a type of cancer that occurs in the soft tissues of the body,
including muscle, tendons, fat, lymph and blood vessels, nerves and the tissue
surrounding joints. While soft tissue sarcoma can be found anywhere in the body,
approximately 40% of these tumors originate in the arms and legs. There are
more than 70 types of soft tissue sarcomas, which are diagnosed through
physical exam, imaging tests and ultimately, biopsy. The American Cancer
Society estimates approximately 12,000 new cases of soft tissue sarcomas in the
United States in 2015. Treatment includes surgical removal of tumor,
chemotherapy, radiation or experimental therapies administered through clinical
trials.

On May 19, 2016 Bellicum Pharmaceuticals, Inc. (Nasdaq:BLCM), a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for cancers and orphan inherited blood disorders, reported that the Company was selected for a poster presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held from June 3 – 7 in Chicago, IL (Press release, Bellicum Pharmaceuticals, MAY 19, 2016, View Source;p=RssLanding&cat=news&id=2169692 [SID:1234512568]).

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Also in June, data from the ongoing BP-004 clinical trial of BPX-501, the Company’s adjunct T cell therapy for allogeneic hematopoietic stem cell transplantation, will be discussed by Dr. Alice Bertaina, Head of Stem Cell Transplant at Ospedale Pediatrico Bambino Gesù in an oral presentation at the 21st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held from June 9 – 12 in Copenhagen, Denmark.

ASCO Presentation Details:

Presentation Title: "Enhanced efficacy and safety of Her2-targeted chimeric antigen receptor (CAR) T cells using MyD88/CD40 costimulation and iCaspase-9 suicide switch"
Abstract Number: 3050
Poster Board: #372
Session Name: Developmental Therapeutics – Immunotherapy
Date: Sunday, June 5, 2016
Presentation Time: 8:00 AM – 11:30 AM CDT (9:00 AM – 12:30 PM EDT)

EHA Oral Presentation Details:

Presentation Title: "Infusion of BPX-501 (donor T cells transduced with the iC9 suicide gene) after α/β T-cell depleted haplo-HSCT in children with acute leukemia: Preliminary results of a Phase I-II trial"
Abstract Number: S523
Session Name: Stem cell transplantation – Clinical 1
Date: Saturday, June 11, 2016
Presentation Time: 4:30 PM – 4:45 PM CEST (10:30 AM – 10:45 AM EDT)