On June 6, 2023 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) and Novocure (NASDAQ: NVCR) reported positive results from the phase 3 LUNAR clinical trial evaluating the use of Tumor Treating Fields (TTFields) therapy together with standard therapies for the treatment of non-small cell lung cancer (NSCLC) at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Zai Laboratory, JUN 6, 2023, View Source [SID1234632527]). The LUNAR trial met its primary endpoint with a statistically significant and clinically meaningful 3-month improvement in median overall survival (OS) when TTFields therapy was added to standard therapies (HR: 0.74, P=0.035).

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Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated median OS of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139). A profound OS benefit from TTFields therapy was demonstrated in the immune checkpoint inhibitor (ICI) subgroup. Patients randomized to receive TTFields therapy and physician’s choice ICI (n=66) demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with ICIs alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone (n=71). TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events.

"The results of the LUNAR study are highly encouraging," said primary investigator Ticiana Leal, M.D., a researcher and medical oncologist at Winship Cancer Institute of Emory University and associate professor and director of the Thoracic Medical Oncology Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta. "The LUNAR trial is the first study in more than seven years to show a significant improvement in overall survival in metastatic non-small cell lung cancer post-platinum chemotherapy. I am heartened by this progress and the potential of this innovative therapy to help many metastatic lung cancer patients in need of new treatment choices following platinum therapy, without added systemic toxicity."

"The significant improvement in overall survival as demonstrated in the LUNAR study is groundbreaking. Lung cancer is the leading cause of cancer-related death in China, and non-small cell lung cancer is the most common form of this disease. The prognosis is often very poor for patients who progress after treatment with a platinum-containing regimen in the front-line setting," said professor Li Zhang, M.D., Sun Yat-sen University Cancer Center. "I am very excited that this novel, non-invasive device can bring significant benefit to patients living with metastatic NSCLC in China."

Baseline characteristics were well balanced between cohorts: median age was 64 years (range, 22-86); 65% male; 96% of patients had an ECOG performance status of 0-1. Patients were enrolled at sites in North America (30%), Western Europe (30%), Eastern Europe (30%) and East Asia (9%). One-year survival rates for patients treated with TTFields therapy together with standard therapies was 53% versus 42% for patients treated with standard therapies alone (P=0.04). A landmark three-year survival analysis for patients treated with TTFields therapy together with standard therapies demonstrated a nearly threefold improvement, extending to 18% versus 7% for patients treated with standard therapies alone (P=0.015). Median progression-free survival (PFS) for patients treated with TTFields therapy together with standard therapies was 4.8 months versus 4.1 months in patients treated with standard therapies alone.
Of patients randomized, 89% had one prior line of systemic therapy and 31% of patients randomized had been treated with an ICI (58% of patients randomized to the docetaxel cohort and 2% of patients randomized to the ICI cohort). ICIs were approved for first-line NSCLC in 2017 during the conduct of the LUNAR study, and PD-L1 expression data were collected thereafter in geographic regions where ICIs had been adopted. Tumor Proportion Scores were available for 151 patients globally (55%) and were well balanced across the cohorts. In all patients treated with ICI and with measured Tumor Proportion Scores, 63% had PD-L1 expression >1%, which is in-line with real-world data. PD-L1 expression data were collected from 83% of patients (69 of 83 patients) enrolled at U.S. sites and were well balanced across the four cohorts.
1

PD-L1 Status:
PD-L1 Expression TTFields + SOC (n=137) SOC
(n=139) TTFields + ICI (n=66) ICI
(n=68) TTFields + DTX (n=71) DTX
(n=71)
<1% 17% 17% 18% 24% 16% 10%
1-49% 27% 29% 26% 27% 28% 31%
>50% 7% 13% 8% 12% 7% 14%

DTX = docetaxel; ICI = immune checkpoint inhibitor; SOC = standard of care
Novocure has submitted the LUNAR clinical trial results for publication in a leading, peer-reviewed medical journal. The LUNAR clinical trial data are expected to serve as the basis for a Premarket Approval (PMA) submission to the U.S. Food and Drug Administration in the second half of 2023. Zai Lab contributed to the China portion of the LUNAR study and plans to submit a Marketing Authorization Application (MAA) to China’s National Medical Products Administration (NMPA) following Novocure’s submission to the FDA.

"I would like to thank our patients, their families and caregivers for participating in the LUNAR trial," said William Doyle, Novocure’s Executive Chairman. "I would also like to thank Dr. Leal and all of our investigators for their expertise and dedication to advancing the care of patients. The LUNAR trial results represent tremendous progress for the treatment of metastatic non-small cell lung cancer, and the LUNAR trial demonstrates the broad and versatile potential of TTFields therapy in improving the survival of cancer patients with high unmet needs. We are energized by the LUNAR results and are moving forward quickly to make TTFields therapy available to patients with metastatic non-small cell lung cancer."

"Each year in China, approximately 740,000 patients are newly diagnosed with non-small cell lung cancer, and most patients are diagnosed at an advanced stage. The LUNAR trial results demonstrate the potential of TTFields to meaningfully extend survival for many patients with advanced, platinum-resistant NSCLC," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. "We are pleased to have been able to contribute to the LUNAR study, and we look forward to working with Novocure to bring TTFields to patients with metastatic NSCLC as soon as possible."

Novocure is dedicated to advancing TTFields therapy for patients with solid tumors. The LUNAR clinical trial is the first of four phase 3 clinical trials expected to readout by the end of 2024 studying the use of TTFields therapy for the treatment of solid tumors of the brain, torso and abdomen. Based on the strength of the LUNAR data, Novocure intends to launch additional phase 3 trials evaluating TTFields therapy in earlier lines of treatment and together with ICIs and other standards of care.

In addition to LUNAR, Zai Lab participated in two of Novocure’s ongoing phase 3 clinical trials – the METIS trial (brain metastases resulting from NSCLC) and the PANOVA-3 trial (pancreatic cancer). Zai Lab also conducted the EF-31 phase 2 trial, in collaboration with Novocure, studying the use of TTFields in the treatment of gastric cancer in China.

Investor Event details

Novocure will host an investor event at 2 p.m. CDT on Tuesday, June 6, 2023. The event will include a presentation and discussion of the LUNAR clinical trial data, featuring leading thoracic oncologists, investigators, and Novocure leadership. A live webcast of the event will be available on the investor relations page of www.novocure.com. For more information or to request in-person attendance, please contact Novocure investor relations ([email protected]).

About LUNAR

LUNAR is a phase 3 trial testing the safety and effectiveness of TTFields therapy when used together with ICI or docetaxel (experimental arm) versus ICI or docetaxel alone (control arm) for patients with metastatic NSCLC who progressed during or after platinum-based therapy. The primary endpoint is superior overall survival of patients treated with TTFields therapy plus ICI or docetaxel versus ICI or docetaxel alone. The powered secondary endpoints are superior overall survival of patients treated with TTFields therapy plus ICI versus ICI cohort and superior overall survival of patients treated with TTFields therapy plus docetaxel versus docetaxel alone. TTFields therapy is intended principally for use with other concomitant standard of care treatments, and LUNAR was designed to generate data that contemplates multiple outcomes, all of which Novocure believes will be clinically meaningful.

About NSCLC in China

Lung cancer is the most commonly diagnosed cancer type and the leading cause of cancer death in China. There were approximately 871,000 new cases and 767,000 deaths of lung cancer in China in 2022, respectively.1 NSCLC accounts for approximately 85% of lung cancer, and approximately 70% of NSCLC is locally advanced or metastatic at initial diagnosis. Similar to the global clinical practice, physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors have been approved for the first-line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, pemetrexed, docetaxel or immune checkpoint inhibitors.

On June 6, 2023 Xenetic Biosciences presented its corporate presentation (Presentation, Xenetic Biosciences, JUN 6, 2023, View Source [SID1234632526]).

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On June 6, 2023 CureMatch, Inc., a healthcare technology company that leverages artificial intelligence (AI) to power precision medicine support for oncology, reported a partnership with xCures, Inc., to connect cancer patients and physicians with optimal investigational or approved therapies (Press release, xCures, JUN 6, 2023, View Source [SID1234632525]). CureMatch will leverage the xCures technology platform to create a comprehensive outline of a cancer patient’s medical history and further enhance its precision cancer treatment recommendation capabilities.

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CureMatch analyzes an individual patient’s genetic sequencing report to determine which drug combinations, out of the millions possible, could most effectively treat their cancer. It then provides oncologists with clear, accessible, predictive treatment analysis in an easy-to-read report that equips them with actionable knowledge tailored for each unique case. With xCures, cancer patients get immediate access to their care summary and all of their medical data in one easy-to-access place, greatly facilitating the finding of promising treatment options, even as they seek second opinions and try new therapies.

The collaboration between CureMatch and xCures will give oncologists clear, comprehensive access to patient records and past treatments, enabling them to make more informed recommendations for combination precision cancer treatments based on the CureMatch report.

"The collaboration between xCures and CureMatch brings together two leading companies at the forefront of digital healthcare innovation," said Mika Newton, CEO of xCures. "By combining our strengths, we are confident that we can accelerate the adoption of precision oncology and improve outcomes for cancer patients globally."

"This partnership represents a significant step forward in harnessing the power of AI technology to optimize cancer care," said Navid Alipour, CEO of CureMatch. "By combining xCures’ patient medical history platform and our treatment-matching algorithm, we can make the process of obtaining genetically tailored, precision cancer therapies a reality for more patients."

On June 6, 2023 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported an expert review article in Blood Advances examining the development path and positioning of REZLIDHIA (olutasidenib), a potent, selective, oral, small-molecule inhibitor of mutant isocitrate dehydrogenase-1 (mIDH1)1, in the mIDH1 relapsed/refractory (R/R) acute myeloid leukemia (AML) treatment landscape (Press release, Rigel, JUN 6, 2023, View Source [SID1234632523]).

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"The compelling safety and efficacy results observed in REZLIDHIA trials to date, marked by encouragingly durable responses, represent an important advance for mIDH1 R/R AML patients and treating physicians," said Justin Watts, M.D., Lead Author and Associate Professor of Medicine, Division of Hematology, Chief, Leukemia Section at the University of Miami Health System. "These data are particularly supportive of the use of REZLIDHIA in mIDH1 R/R AML patients who have failed intensive chemotherapy or venetoclax plus HMA combination therapy. The results validate ongoing studies evaluating olutasidenib in frontline and R/R settings as a monotherapy and in combination with azacitidine with or without prior exposure to HMA or IDH1 inhibitor."

"We are pleased with the growing body of evidence and thought leader support for REZLIDHIA as a differentiated and potentially market-leading therapy for mIDH1 R/R AML patients," said Raul Rodriguez, Rigel’s president and CEO. "We remain committed to delivering this important treatment option to mIDH1 R/R AML patients and look forward to data from the ongoing studies of REZLIDHIA in broader mIDH1 AML treatment settings."

Key points from the paper are summarized below:

REZLIDHIA demonstrated highly durable remission rates, representing a critical addition to the mIDH1 AML treatment landscape
The available data support the use of REZLIDHIA as monotherapy in R/R AML patients who have failed intensive chemotherapy or venetoclax plus HMA combination therapy
The authors state that the choice of which IDH1 inhibitor to use first in these patients is not yet clear, although given the available data REZLIDHIA is recommended in venetoclax plus HMA failures
Among the 12 patients with prior exposure to venetoclax, the ORR was 50% with four patients achieving CR/CRh (33%; 95% CI, 9.9–65.1) and two patients had CRi
Ongoing studies (NCT02719574) could clarify the role of REZLIDHIA in treatment naïve mIDH1 AML (including when given in combination with azacitidine) and in R/R mIDH1 AML with prior IDH1 inhibitor exposure. Further studies assessing maintenance, triplet therapy, and sequencing with venetoclax and azacitidine are being considered.
The paper, titled "Olutasidenib: from Bench to Bedside," was published online in Blood Advances and can be accessed here.

Rigel announced a peer-reviewed publication of data in Blood Advances in February 2023, which summarizes clinical results from the Phase 2 registrational trial of REZLIDHIA in patients with mIDH1 R/R AML.

On December 1, 2022, the U.S. Food and Drug Administration (FDA) approved REZLIDHIA (olutasidenib) capsules for the treatment of adult patients with R/R AML with a susceptible IDH1 mutation as detected by an FDA-approved test. REZLIDHIA became commercially available in the U.S. on December 22, 2022. REZLIDHIA was added to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for acute myeloid leukemia (AML) on January 13, 2023 as a recommended targeted therapy for adult patients with R/R AML with isocitrate dehydrogenase-1 (IDH1) mutation.

About AML
Acute myeloid leukemia (AML) is a rapidly progressing cancer of the blood and bone marrow that affects myeloid cells, which normally develop into various types of mature blood cells. AML occurs primarily in adults and accounts for about 1 percent of all adult cancers. The American Cancer Society estimates that in the United States alone, there will be about 20,380 new cases, most in adults, in 2023.2

Relapsed AML affects about half of all patients who, following treatment and remission, experience a return of leukemia cells in the bone marrow.3 Refractory AML, which affects between 10 and 40 percent of newly diagnosed patients, occurs when a patient fails to achieve remission even after intensive treatment.4 Quality of life declines for patients with each successive line of treatment for AML, and well-tolerated treatments in relapsed or refractory disease remain an unmet need. 

About REZLIDHIA
INDICATION

REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME
Differentiation syndrome, which can be fatal, can occur with REZLIDHIA treatment. Symptoms may include dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, hypotension, fever, and weight gain. If differentiation syndrome is suspected, withhold REZLIDHIA and initiate treatment with corticosteroids and hemodynamic monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS
Differentiation Syndrome
REZLIDHIA can cause differentiation syndrome. In the clinical trial of REZLIDHIA in patients with relapsed or refractory AML, differentiation syndrome occurred in 16% of patients, with grade 3 or 4 differentiation syndrome occurring in 8% of patients treated, and fatalities in 1% of patients. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with REZLIDHIA included leukocytosis, dyspnea, pulmonary infiltrates/pleuropericardial effusion, kidney injury, fever, edema, pyrexia, and weight gain. Of the 25 patients who experienced differentiation syndrome, 19 (76%) recovered after treatment or after dose interruption of REZLIDHIA. Differentiation syndrome occurred as early as 1 day and up to 18 months after REZLIDHIA initiation and has been observed with or without concomitant leukocytosis.

If differentiation syndrome is suspected, temporarily withhold REZLIDHIA and initiate systemic corticosteroids (e.g., dexamethasone 10 mg IV every 12 hours) for a minimum of 3 days and until resolution of signs and symptoms. If concomitant leukocytosis is observed, initiate treatment with hydroxyurea, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms. Differentiation syndrome may recur with premature discontinuation of corticosteroids and/or hydroxyurea treatment. Institute supportive measures and hemodynamic monitoring until improvement; withhold dose of REZLIDHIA and consider dose reduction based on recurrence.

Hepatotoxicity
REZLIDHIA can cause hepatotoxicity, presenting as increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased blood alkaline phosphatase, and/or elevated bilirubin. Of 153 patients with relapsed or refractory AML who received REZLIDHIA, hepatotoxicity occurred in 23% of patients; 13% experienced grade 3 or 4 hepatotoxicity. One patient treated with REZLIDHIA in combination with azacitidine in the clinical trial, a combination for which REZLIDHIA is not indicated, died from complications of drug-induced liver injury. The median time to onset of hepatotoxicity in patients with relapsed or refractory AML treated with REZLIDHIA was 1.2 months (range: 1 day to 17.5 months) after REZLIDHIA initiation, and the median time to resolution was 12 days (range: 1 day to 17 months). The most common hepatotoxicities were elevations of ALT, AST, blood alkaline phosphatase, and blood bilirubin.

Monitor patients frequently for clinical symptoms of hepatic dysfunction such as fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. Obtain baseline liver function tests prior to initiation of REZLIDHIA, at least once weekly for the first two months, once every other week for the third month, once in the fourth month, and once every other month for the duration of therapy. If hepatic dysfunction occurs, withhold, reduce, or permanently discontinue REZLIDHIA based on recurrence/severity.

ADVERSE REACTIONS
The most common (≥20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased, alanine aminotransferase increased, potassium decreased, sodium decreased, alkaline phosphatase increased, nausea, creatinine increased, fatigue/malaise, arthralgia, constipation, lymphocytes increased, bilirubin increased, leukocytosis, uric acid increased, dyspnea, pyrexia, rash, lipase increased, mucositis, diarrhea and transaminitis.

DRUG INTERACTIONS

Avoid concomitant use of REZLIDHIA with strong or moderate CYP3A inducers.
Avoid concomitant use of REZLIDHIA with sensitive CYP3A substrates unless otherwise instructed in the substrates prescribing information. If concomitant use is unavoidable, monitor patients for loss of therapeutic effect of these drugs.
LACTATION
Advise women not to breastfeed during treatment with REZLIDHIA and for 2 weeks after the last dose.

GERIATRIC USE
No overall differences in effectiveness were observed between patients 65 years and older and younger patients. Compared to patients younger than 65 years of age, an increase in incidence of hepatotoxicity and hypertension was observed in patients ≥65 years of age.

HEPATIC IMPAIRMENT
In patients with mild or moderate hepatic impairment, closely monitor for increased probability of differentiation syndrome.

Click here for Full Prescribing Information, including Boxed WARNING.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

REZLIDHIA is a registered trademark of Rigel Pharmaceuticals, Inc.

On June 6, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCBD) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported the Company’s strategic pharma partnering initiative, as its lead product candidate, PRP, advances towards a Phase I, First-In-Human (FIH) study in advanced cancer patients (Press release, Propanc, JUN 6, 2023, View Source [SID1234632522]). Over the past several years, management has initiated discussions with potential strategic collaborators to provide the resources to advance PRP into clinical development and for future commercialization. These include Australia’s largest cancer research institute, a merged group of hospitals located in the Andalusian region of Spain and a multi-billion-dollar, global, biomedical company with over 50,000 employees. The strategic goal of these potential collaborations is to develop and commercialize PRP for the treatment and prevention of metastatic cancer from solid tumors in major pharmaceutical markets worldwide.

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Australia’s largest cancer research institute, the Peter MacCallum Cancer Center, is dedicated to caring for people affected by cancer with over 3,300 staff, including 750 laboratory and clinical researchers, all focused on providing better treatments, better care and potential cures for cancer. Initial discussions have taken place with a principal investigator, and will recommence upon final drug manufacture of PRP for the upcoming clinical study.

Discussions have also taken place with clinical trial investigators at Jaén University Hospitals, in the Andalusian region of Spain. After consideration of scientific literature supporting the use of PRP to prevent recurrence and metastasis of solid tumors, two clinical oncologists from Jaén University Hospital confirmed their interest in evaluating the performance of PRP on behalf of their institution. The Company will consider the conduct of Phase II proof of concept studies, most likely for pancreatic and ovarian cancers, in this region of Spain as possible multi-trial centers to accommodate larger patient numbers.

Finally, market outreach activities have been undertaken by the Company at several different stages of development of PRP to assess the interest in possible strategic partnering of the Company’s lead asset for global pharmaceutical markets. The most recent and encouraging discussion was held with a Vice President, Global Head Search and Evaluation from a top ten, global, biomedical company who expressed a desire to review clinical results from randomized, controlled clinical studies, as PRP enters the next stage of development. The management team at Propanc expects to present interim results after the first 3 months of the Phase I, FIH study in approximately 30 to 40 advanced cancer patients at the Peter MacCallum Cancer Center in Melbourne, Australia. Several other major companies were approached and Propanc expects to resume discussions during the next stage of clinical development for PRP.

James Nathanielsz, BAS, MEI, Propanc’s Chief Executive Officer, said, "Our vision is to deliver a long-term therapy for the treatment and prevention of metastatic cancer from solid tumors, by targeting and eradicating cancer stem cells, free from the side effects normally associated with standard treatment approaches. Metastatic cancer is the leading cause of death for sufferers. We continue to expend every effort to find the best strategic partners for the global commercialization of PRP."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers.