On May 19, 2016 Cerulean Pharma Inc. (NASDAQ:CERU), a clinical-stage company developing nanoparticle-drug conjugates (NDCs), reported that the Company will present in an oral session Phase 1b results of an ongoing clinical trial of CRLX101 in combination with weekly paclitaxel in patients with relapsed ovarian cancer at the Gynecologic Oncology 2016 Conference being held May 19-21 in San Antonio, Texas (Press release, Cerulean Pharma, MAY 19, 2016, View Source [SID:1234512613]). This trial is being conducted by Cerulean in collaboration with the GOG Foundation, Inc.

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Details of the presentation are as follows:

Title: A Phase 1b study of the nanoparticle-drug conjugate (NDC) CRLX101 in combination with weekly paclitaxel in patients with advanced neoplasms including platinum-resistant tumors
Date/Time: Thursday, May 19, 2016, 12:20-12:50 pm CDT
Location: Hilton San Antonio Airport Hotel
Summary: As previously announced, a maximum tolerated dose and a recommended Phase 2 dose of 15 mg/m2 for CRLX101 (bi-weekly) and weekly paclitaxel 80 mg/m2 (3 weeks on; 1 week off) have been declared. Three patients were treated with 12 mg/m2 of CRLX101 and six patients were treated with 15 mg/m2 of CRLX101. The combination appears to be generally well tolerated, and no dose limiting toxicities observed at either dose level. To date, the only treatment-related adverse events were one Grade 3 and one Grade 4 neutropenia. The most common adverse events ( > 30%) were fatigue, neutropenia, and nausea. Objective RECIST responses were achieved by 5 of 9 patients (56%), including one patient who experienced complete disappearance of the tumor but had detectable CA125. Importantly, 3 of the 5 patients who achieved objective RECIST responses were previously treated with Avastin (bevacizumab). Based on the antitumor effect observed in these first nine patients, the trial will be expanded.

About GOG Foundation, Inc. (GOG Foundation)

The GOG Foundation, Inc. (GOG Foundation) is an independent international non-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis and distribution of results. Continuous evaluation of the GOG Foundation’s processes is utilized in order to constantly improve the quality of patient care. The GOG Foundation conducts clinical trials for patients with a variety of gynecologic malignancies, including cancers that arise from the ovaries, uterus, cervix, vagina, and vulva. The GOG Foundation is a separate entity from the National Clinical Trials Network groups that are funded by the National Cancer Institute.

About CRLX101

CRLX101 is a nanoparticle-drug conjugate (NDC) designed to concentrate in tumors and slowly release its anti-cancer payload, camptothecin, inside tumor cells. CRLX101 inhibits topoisomerase 1 (topo 1), which is involved in cellular replication, and also inhibits hypoxia-inducible factor-1α (HIF-1α), which research suggests is a master regulator of cancer cell survival mechanisms. CRLX101 has shown activity in four different tumor types, both as monotherapy and in combination with other cancer treatments. CRLX101 is in Phase 2 clinical development and has been dosed in more than 350 patients. The U.S. FDA has granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma.

On May 19, 2016 Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, reported new clinical data on DecisionDx-UM, its gene expression profile (GEP) test to predict metastasis in patients diagnosed with uveal melanoma (Press release, Castle Biosciences, MAY 19, 2016, View Source [SID:1234512612]). The new data will be highlighted in a presentation at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL from June 3-7.

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In a poster presentation titled, "A Prospective, Multi-Center Study to Evaluate the Performance and Clinical Utility of a 15-Gene Expression Profile for Uveal Melanoma" (Abstract #9575), Castle Biosciences researchers and collaborators will present findings from 70 patients in the prospective, multi-center CLEAR (Clinical Application of DecisionDx-UM Gene Expression Assay Results) study. The CLEAR study tracked clinical management and metastatic outcomes of patients with low-risk Class 1 or high-risk Class 2 gene test results who had no evidence of distant metastasis at the time of primary tumor treatment. Surveillance mode and frequency were independently determined by participating physicians as they deemed appropriate for low-risk Class 1 and high-risk Class 2 patients.

Study Results

37 patients (53%) had a low-risk Class 1 GEP test result; 33 patients (47%) had a high-risk Class 2 result;
Impact on clinical management:
All Class 2 patients were managed with high intensity surveillance (imaging and/or liver function tests every 3-6 months);
81% of Class 1 patients were managed with low intensity surveillance (imaging and/or liver function tests every year);
There was a significant difference in management of Class 1 and Class 2 patients (p=2.1×10-13);
33% of Class 2 patients were referred to a medical oncologist for surveillance and/or clinical trial enrollment, compared to 11% of Class 1 patients (p=0.04).
Clinical outcomes:
Overall, two Class 1 patients and 12 Class 2 patients developed metastasis (p=0.002) with a median follow-up of 27.3 months;
At 3 years, metastasis-free survival rates were 100% for Class 1 and 63% for Class 2 (p=0.003).
"This prospective study demonstrated clinically and statistically significant impact on follow-up treatment consistent with a previously published retrospective multi-center clinical utility study," commented Derek Maetzold, President and CEO of Castle Biosciences. "In addition, the clinical performance of the test is consistent with previously published prospective multi-center and single-center studies, confirming the robustness of the DecisionDx-UM test."

About Uveal Melanoma
Uveal melanoma, while rare, is the most common form of eye cancer in the United States with about 1,600 diagnoses per year. This form of eye cancer may occur in any of the three parts of the uvea. Similar to other melanomas, uveal melanoma begins in cells called melanocytes that help produce the pigments of the skin, hair and eyes. While more common in patients who are middle-aged with fair skin, uveal melanoma can affect people of all complexions and ages.
Although a small percentage (3%) of patients with uveal melanoma have detectable metastatic lesions at the time of diagnosis or treatment of the primary tumor, up to 50% of patients will subsequently develop metastatic disease. This necessitates a rigorously validated, accurate and reliable tool to identify patients likely to develop distant metastasis.

About DecisionDx-UM
The DecisionDx-UM test measures the gene expression profile (GEP), or molecular signature, of an individual’s tumor and identifies with high accuracy the likelihood of metastasis.
The DecisionDx-UM test is standard of care in the management of uveal melanoma in the majority of ocular oncology practices. It is the only test for uveal melanoma that has achieved National Cancer Institute/National Comprehensive Cancer Network Level of Evidence 1A, a critical factor in test adoption and clinical decision-making. Additionally, the American Joint Committee on Cancer recommends gene expression profile testing for use as the results are "clinically significant." The American Joint Committee on Cancer (AJCC, version 7, 2010) is the only national organization that reviews uveal melanoma and the DecisionDx-UM test is the only clinically available GEP test for use in the U.S. The test has been validated in multiple prospective and retrospective studies. More information about the test and disease can be found at www.MyUvealMelanoma.com.

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 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 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."