© 2019 PR Newswire

TORONTO, CANADA / ACCESSWIRE / AUGUST 6, 2019 / Soricimed Biopharma Inc. ("Soricimed"), a clinical-stage pharmaceutical company developing first-in-class, targeted cancer therapeutics, announced today that The University of Texas MD Anderson Cancer Center (MDACC) has activated an Investigator Initiated Clinical trial of Soricimed’s lead drug candidate, SOR-C13 in late stage pancreatic cancer.

This trial was initiated by Siqing Fu, MD PhD, a member of the Department of Investigational Cancer Therapeutics at MDACC, one of the world’s most respected cancer research centers, based on the results of Soricimed’s multi-center Phase 1 clinical trial in patients with late-stage solid tumor cancer. The Phase 1 trial concluded that SOR-C13 was safe and well tolerated, with preliminary indication of anticancer activity, including tumor regression in two late stage pancreatic cancer patients. The objectives of this Phase 1b investigator-initiated trial are to refine dosing and further explore safety and efficacy of SOR-C13 in late-stage solid tumor cancer.

“We are pleased to be conducting this trial with the support of Soricimed Biopharma Inc.”, stated Principal investigator, Siqing Fu, MD PhD, Professor at the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center. “Pancreatic cancer is a difficult to treat cancer. We were intrigued by the positive efficacy signals we observed in the pancreatic cancer patients treated with SOR-C13 at our site in Soricimed’s Phase 1 clinical trial. With this next trial, among other critical data, we look to expand our data in pancreatic cancer patients and confirm the efficacy results seen earlier.”

“We’re pleased to extend our clinical relationship with MD Anderson in advancing our understanding of the potential of SOC-C13 to treat pancreatic cancer and other important cancers,” said Dominique Dugourd, Vice President Research and Development, Soricimed Biopharma Inc. “It is our hope that our commitment to research will eventually yield a novel therapy for patients with significant unmet treatment needs.”

The single arm, open label study of SOR-C13 (Clinicaltrials.gov identifier NCT03784677), will enroll approximately 36 patients with advanced solid tumor cancers with an emphasis on enrolling those patients with late-stage pancreatic cancer. The study’s primary objective is to define a maximum tolerated dose (MTD) for SOR-C13 and further define its safety profile. Secondary objectives include the evaluation of clinical response to SOR-C13 and to determine predictive biomarkers in patients who have achieved objective responses. The initial dose escalation cohorts will be followed by an expansion cohort to monitor clinical response.

To learn more about the clinical trial visit: https://clinicaltrials.gov/ct2/show/NCT03784677

About SOR-C13: SOR-C13 is a selective inhibitor of TRPV6, a calcium oncochannel over-expressed by solid tumour cancers. SOR-C13 binds with high affinity and selectivity and disrupts the function of TRPV6. TRPV6 plays a central role in a biochemical cascade that results in the upregulation of an array of pro-cancerous genes. TRPV6 is considered to be an important target for novel anticancer therapy. SOR-C13 is the first highly specific TRPV6 inhibitor to be identified and taken into clinical development.

About Soricimed Biopharma: Soricimed Biopharma Inc., is a private, clinical-stage company focused on developing first-in-class targeted cancer therapies. Our lead drug candidate, SOR-C13, completed a multi-center Phase 1 trial in late-stage solid tumor cancer. SOR-C13 was shown to be safe and well tolerated with over half of the patients treated having stable disease after 2 treatment cycles. Two patients with stage IV pancreatic cancer showed tumor size reduction with one patient achieving a 30% reduction in the size of the primary pancreatic tumor. The U.S. FDA granted orphan-drug designation to SOR-C13 for the treatment of ovarian cancer and for the treatment of pancreatic cancer. Privately held, Soricimed is funded through private investors and various programs from the Governments of Canada and New Brunswick. For more information please visit, www.soricimed.com

For More Information:

Julie A. Fotheringham
Partner, HAGEMAN Communication
[email protected]
416.951.7988

SOURCE: Soricimed Biopharma Inc.

View source version on accesswire.com: 
https://www.accesswire.com/554360/Soricimed-Announces-Investigator-Initiated-Phase-1b-Clinical-trial-of-its-Lead-Drug-Candidate-in-Late-Stage-Pancreatic-Cancer

NEW YORK — While new drugs for cancer are helping patients fight the disease, they also produce side effects that can affect the hair, skin and nails and can significantly affect quality of life and, potentially, the ability to continue treatment, according to a press release issued here at the American Academy of Dermatology Summer Meeting.

“Approximately half of patients who undergo immunotherapy and receive targeted cancer medications experience a skin-related reaction to the medication,” Anisha Patel, MD, FAAD, an associate professor of dermatology and internal medicine at the University of Texas MD Anderson Cancer Center in Houston, said in the release.

As many as 60% of patients experience hair, skin and nail reactions when combinations of targeted cancer therapies are used, according to Patel.

Patel urges patients to seek treatment from a board-certified dermatologist prior to beginning any cancer therapies. Dermatologists can help patients with preventative strategies to reduce discomfort, such as limiting ultraviolet exposure, reducing friction and trauma to the hands and feet and avoiding manipulation of the nail cuticles, according to the release.

Simple adjustments before treatment can greatly improve a patient’s comfort throughout therapy, according to Patel.

Many cancer therapies make the skin extremely sensitive to UV light, so knowing up front if the medication requires strict sun protection will help prevent rashes and delays in care, she added.

Potential side effects with these therapies include skin rashes, itchiness, changes in hair texture, inflammation around the nails and blisters in the mouth, Patel continued.

“Dermatologists are an important part of an oncology patient’s treatment team,” Patel said in the release. “They can help reduce pain or discomfort associated with cancer therapy and limit visible side effects, increasing the patient’s ability to continue treatment, as well as the opportunity for a positive outcome.”

Disclosures: Patel reports no relevant financial disclosures.

(WASHINGTON, August 8, 2019) — New data suggest that people who have a parent, sibling, or child with blood cancer have a higher likelihood of being diagnosed with the disease. The study published online today in Blood offers the first evidence that such familial risks exist across the spectrum of hematologic malignancies.

Age of diagnosis, whether the relative is a parent, sibling, or child, and the number of affected first-degree relatives play a defining role in the relative risk of developing certain blood cancers, according to the study.

“This information improves our understanding of the causes of – and potential inherited predisposition to – blood cancers and should inform the identification and characterization of genetic risk factors for blood cancer, as well as how we best clinically manage patients and their relatives,” said Amit Sud, MD, PhD, of The Institute of Cancer Research, London, and the study’s lead author. “The results should also encourage conversations among families, clinicians, and patients about familial risk.”

While earlier studies have demonstrated the increased risk of blood cancers in first-degree relatives of affected individuals, this is the largest and most comprehensive population-based evaluation to date.

Cases with a familial link represented 4.1 percent of all blood cancer diagnoses – higher than cancers of the nervous system, kidney and pancreas, but lower than those of the breast, colorectum, and prostate, which range from 8 to 15 percent, researchers report. Highest relative risks were seen for certain Hodgkin lymphoma (HL) subtypes, lymphoplasmacytic lymphoma, and mantle cell lymphoma. Markedly elevated familial risks were also observed for polycythemia vera, myelodysplasia and essential thrombocythemia. 

While there are currently no definitive screening initiatives for blood cancers, a 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia recognized familial disease as an essential component of diagnosing certain subsets of blood cancers and underscores the need to further examine and understand familial risk. Developing definitive screening protocols based on evidence is an emerging area of research.

“We hope these robust data will be used to inform guidelines on genetic testing and screening. Certainly there are a number of individuals, such as those with a relative diagnosed at a young age and or with more than one affected first-degree relatives, for whom counseling, genetic testing, and surveillance may be appropriate,” Dr. Sud said. 

The present analysis drew from 16 million people in the Swedish Family-Cancer Database, ultimately including 153,115 patients with a confirmed blood cancer and 391,131 first-degree relatives, which allowed Dr. Sud and colleagues to fully characterize familial risk across all blood cancer types. For specific blood cancers such as chronic lymphocytic leukemia (CLL), the increase in risk is dependent on the age of the affected relative; whether it is a parent, sibling, or child; and the number of affected first-degree relatives. For example, for non-Hodgkin lymphoma, HL, and CLL, the risk was higher among those who had a sibling with the disease, whereas others blood cancers were more likely to occur if a parent had been diagnosed. Generally, the familial risk was more pronounced when relatives were diagnosed at younger ages. Dr. Sud added that the analysis also has potential implications for the selection of related stem-cell donors used for the treatment of these malignancies.

In addition to its size and long follow-up, another strength of the analysis is its use of registry data for which almost all blood cancer cases in the Swedish population had been recorded. Still, researchers say the findings may not be applicable to economically developing countries that tend to have different tumor incidence rates and potentially different environmental and genetic risk factors.

The study was conducted as a collaboration between European research institutes: The Institute of Cancer Research in London, the German Cancer Research Centre in Heidelberg, and Lund University in Sweden.

Blood (www.bloodjournal.org), the most cited peer-reviewed publication in the field of hematology, is available weekly in print and online. Blood is a journal of the American Society of Hematology (ASH) (www.hematology.org), the world’s largest professional society concerned with the causes and treatment of blood disorders.

Contact:
Leah Enser, American Society of Hematology
[email protected]; 202-552-4927

Adjuvant chemoradiotherapy improved overall survival for women with locally advanced endometrial cancer compared with radiation alone, a post-hoc analysis of the phase III PORTEC-3 trial found.

With adjustment for stratification factors, overall survival (OS) at 5 years was 81.4% in the chemoradiotherapy group compared with 76.1% in the group receiving radiotherapy alone (adjusted HR 0.70, 95% CI 0.51-0.97, P=0.034), reported Stephanie de Boer, MD, of Leiden University Medical Center in the Netherlands, and colleagues.

And in their study of over 600 patients with stage I-III endometrial cancer, failure-free survival (FFS) at 5 years was 76.5% with chemoradiotherapy versus 69.1% with radiation alone (HR 0.70, 95% CI 0.52-0.94, P=0.016).

"These updated results of the PORTEC-3 trial, with a longer median follow-up of 72 months and with 75% of participants having reached 5 years of follow-up, showed a significant improvement in both overall and failure-free survival with chemoradiotherapy versus radiotherapy alone for high-risk endometrial cancer," they wrote in the Lancet Oncology.

For first site of recurrence, distant metastases were the most common, with a 5-year probability of 21.4% versus 29.1% for the chemoradiotherapy and radiation-alone groups, respectively (HR 0.74, 95% CI 0.55-0.99, P=0.047). Isolated pelvic and vaginal recurrences were rare, with no significant differences seen between groups.

"In the aftermath of these potentially practice-changing results, additional questions are raised," Marcus Randall, MD, of the University of Kentucky in Lexington, wrote in an accompanying editorial. Do the findings apply to all subgroups? Would chemotherapy alone be sufficient in the adjuvant setting? Is there a "preferred way" to combine chemotherapy with radiation?

"Taking into account the statistical limitations of subgroup analyses," he said, "the therapeutic benefit of combined chemotherapy and radiotherapy (vs radiotherapy alone) appeared to remain confined to patients with stage III disease and those with serous carcinomas of all stages."

For the stage III patients, 5-year OS and FFS were both significantly improved for the chemoradiotherapy group versus radiation-alone group:

• OS: 78.5% vs 68.5% (HR 0.63, 95% CI 0.41-0.99, P=0.043)
• FFS: 70.9% vs 58.4% (HR 0.61, 95% CI 0.42-0.89, P=0.011)

For stage I-II disease, survival outcomes modestly favored the combined adjuvant treatment numerically, but neither of the differences were significant:

• OS: 83.8% vs 82.0%
• FFS: 81.3% vs 77.3%

The study investigators noted that "the minimal benefit in failure-free survival and overall survival in stage I-II endometrial cancer achieved with chemoradiotherapy does not seem to justify the increased frequency of adverse events, impaired quality of life, and longer treatment duration of combined treatment for these patients."

Patients with serous histology also appeared to benefit more from the addition of chemotherapy in the post-hoc analysis. After adjusting for stratification factors, OS at 5 years was 71.4% versus 52.8% in the chemoradiotherapy and radiotherapy groups, respectively (HR 0.48, 95% CI 0.24-0.96, P=0.037). And FFS at 5 years was 59.7% versus 47.9% (HR 0.42, 95% CI 0.22-0.80, P=0.008).

For the question of whether chemotherapy might be sufficient alone in the adjuvant setting, Randall pointed to two NRG/GOG trials.

In stage I-II disease, Randall noted that in NRG/GOG 249 patients treated with chemotherapy plus vaginal cuff brachytherapy had no improvement in overall or relapse-free survival compared with those treated with pelvic radiotherapy alone.

"However, the incidence of nodal failure was significantly higher in the absence of pelvic radiation therapy, and acute toxicity was greater in the vaginal cuff brachytherapy group," he wrote.

Most recently, the phase III GOG 258 trial demonstrated similar outcomes between chemoradiotherapy and chemotherapy alone as adjuvant treatment for women with stage III-IVA endometrial cancer. At 5 years, 59% of women in the chemotherapy arm were estimated to be alive and relapse-free compared with 58% in the chemotherapy-alone arm.

But Randall noted that while the combined therapy did not improve recurrence-free survival or OS, "nodal and vaginal failures were significantly lower when radiotherapy was given."

Finally, he asked whether the chemoradiotherapy approach taken in both PORTEC-3 and GOG 258 was indeed the best option.

"When NRG/GOG 258 was designed, there was vigorous debate about the combined modality group, with various investigators favoring a sandwich regimen typically involving three cycles of chemotherapy, followed by involved-field radiotherapy, and then additional chemotherapy," he wrote, adding that "multiple studies (retrospective and prospective) have demonstrated the safety and efficacy of the so-called sandwich approach."

From 2006 to 2013, the PORTEC-3 trial randomized 660 patients 1:1 to either radiotherapy alone or chemoradiotherapy. Radiotherapy consisted of 48.6 Gy in 1.8 Gy fractions given 5 days per week, while chemoradiotherapy consisted of two cycles of 50 mg/m² cisplatin given intravenously during radiotherapy, and then four cycles of intravenous carboplatin AUC5 plus paclitaxel 175 mg/m².

Adverse events (AEs) of grade ≥2 were significantly more frequent in the combined adjuvant therapy group, occurring in 38% of women versus 23% in the radiation-alone group (P=0.002), with 5-year neuropathy rates occurring in 6% versus 0%, respectively.

Grade 3 AEs were similar between the chemoradiotherapy and radiation-alone groups (8% vs 5%, P=0.24), with hypertension being the most common event (2% in each group). Only one grade 4 AE was reported (in the chemoradiotherapy arm), and there were no treatment-related deaths.

Niraparib demonstrated clinically relevant activity among women with heavily pretreated ovarian cancer, particularly those with homologous recombination deficiency-positive, platinum-sensitive disease, according to findings from the phase 2 QUADRA study published in The Lancet Oncology.

The results, which also showed no new safety signals, support extending the use of poly(ADP-ribose) polymerase (PARP) inhibitors to a wider population of women with late-line ovarian cancer, including those without BRCAmutations, according to the researchers.

“This is another piece of the puzzle that helps our patients live longer,” Kathleen Moore, MD, associate director of clinical research at Stephenson Cancer Center at University of Oklahoma College of Medicine, said in a press release. “There haven’t been a lot of studies done on patients without BRCA mutations who have received four, five, six or more lines of chemotherapy. That’s who this trial sought to study.”

As many as 25% of women without a BRCA mutation can develop homologous recombination deficiency (HRD), which means they can derive benefits from PARP inhibitors such as niraparib (Zejula, Tesaro).

In the multicenter, open-label, single-arm, phase 2 study, Moore and colleagues enrolled 463 women aged 18 years and older (median age, 65 years; range, 29-91) with metastatic, relapsed, high-grade serous (grade 2 or 3) epithelial ovarian, fallopian tube or primary peritoneal cancer who had undergone at least three prior chemotherapy regimens. Patients had ECOG performance status of 0 or 1 and adequate organ function and had received a median four (interquartile range [IQR], 3-5) previous lines of treatment.

The study was conducted at 56 sites in the United States and Canada.

Women received 300 mg oral niraparib once daily starting on day 1 and continuously through each 28-day cycle until disease progression, unacceptable toxicity or withdrawal of consent. The prevalence of confirmed overall response among women with HRD-positive tumors — including those with and without BRCA mutations — who showed sensitivity to their last platinum-based therapy served as the study’s primary objective. Efficacy analyses also were conducted among all dosed patients with evaluable disease at baseline.

Median follow-up for OS was 12.2 months (IQR, 3.7-22.1).

Among all women who initiated treatment, 151 (33%) had platinum-resistant disease and 161 (35%) had platinum-refractory disease.

Results showed 13 of 47 women with platinum-sensitive, HRD-positive tumors naive to PARP inhibitors demonstrated overall response (27.65%; 95% CI, 15.6-42.6). These women had median PFS of 5.5 months (95% CI, 3.5-8.2) and median duration of response of 9.2 months (95% CI, 5.9 to not estimable), and 68% (95% CI, 53-81) achieved disease control.