PharmaMar has signed a Memorandum of Understanding with the Indonesian Oceanographic Research Center to study Indonesia's marine biodiversity for new antitumor compounds. The collaboration aims to develop cutting-edge technology and address unmet medical needs in cancer research.
PharmaMar and Chugai agree on an early termination of their license agreement for Zepsyre in Japan, allowing PharmaMar to regain rights to the compound. PharmaMar will receive €3,000,000 from Chugai and can now pursue new partnerships for the drug.
The ADMYRE trial found a statistically significant increase in overall survival with plitidepsin plus dexamethasone compared to dexamethasone alone. The two-stage model showed a 11.6-month overall survival in the plitidepsin arm, exceeding 6.4 months for dexamethasone.
The multicenter phase II trial assessed the safety and efficacy of lurbinectedin in different solid tumors, with an ORR of 39.3% seen in recurrent small-cell lung cancer patients. The median duration of response was 6.2 months and the median overall survival was 12 months.
IDMC recommends continuing Zepsyre® (lurbinectedin, PM1183) Phase III trial in small-cell lung cancer patients. The pivotal trial assesses the efficacy of PM1183 in combination with doxorubicin compared to standard treatments.
PharmaMar will present data on Yondelis and lurbinectedin, showcasing clinical advances in soft tissue sarcoma, breast cancer, and small-cell lung cancer. The company's molecules have demonstrated efficacy and safety in various studies, including a phase III trial for small-cell lung cancer.
Tivanisiran, an RNAi-based compound, shows promise in treating dry eye syndrome by improving ocular inflammatory parameters and reducing symptoms. The Phase III Helix study will evaluate its efficacy in over 300 patients across six countries.
Sylentis presents preclinical and clinical results for three ophthalmological compounds targeting dry eye syndrome, macular degeneration and eye allergies. The company is a leader in RNAi technology and has developed new treatments for ophthalmological and inflammatory illnesses.
PharmaMar presents newly discovered oncogenic properties of eEF1A2, the target of plitidepsin. The protein's interaction with eEF1A2 favors tumor growth, but plitidepsin inhibits this bond, inducing cell death and apoptosis.
PharmaMar initiates EMA re-examination process for Aplidin, a marine-derived anticancer agent targeting multiple myeloma. The re-examination procedure aims to confirm or update the negative opinion on its Marketing Authorization Application.
PharmaMar has signed a commercialization and distribution license agreement with Megapharm Ltd. for the marine-derived anticancer drug Aplidin² (plitidepsin) in Israel and the Palestinian Authority. The agreement allows for registration and distribution of Aplidn², providing access to a novel therapy for multiple myeloma patients.
PharmaMar's plitidepsin demonstrated improved progression-free survival and overall survival compared to dexamethasone alone, with a significant reduction in the risk of progression. The study also showed better quality of life evolution and a novel mechanism of action that targets eEF1A2 protein.
The Phase II study demonstrated an overall response rate of 60%, including partial responses in 12% and stabilization of the disease in 48% of cases. Median progression-free survival was also achieved at 3 months, with manageable adverse effects related to myelosuppression.
Zepsyre, a marine-derived anticancer drug, will be commercialized in South Korea under the deal. PharmaMar retains exclusive production rights and will sell to Boryung Pharm for commercial use.
The World Health Organization has approved tivanisiran as the international nonproprietary name for SYL1001, a compound developed by Sylentis using RNA interference technology. The drug is administered in ophthalmic drops and aims to improve quality of life for patients with dry eye syndrome, a condition affecting millions worldwide.
PharmaMar's Phase I/II trial combining PM1183 with doxorubicin shows a progression-free survival of 5.3 months, surpassing historical data for topotecan. The study also reveals manageable adverse events with no mucositis or neuropathy, paving the way for the pivotal Phase III Atlantis trial.
PharmaMar is conducting a Phase I clinical study to identify the optimal dose of PM14 in patients with advanced solid tumors. The trial aims to assess the safety profile and pharmacokinetics of PM14, with approximately 50 patients forecasted to participate.
PharmaMar presents positive results of PM1183 (lurbinectedin) in a cohort of 36 patients with advanced and relapsed small-cell lung cancer (SCLC), achieving an objective response rate of 36%. This finding is significant given the limited therapeutic options for SCLC, which has a high mortality rate.
Aplidin, an anticancer agent with no hematological toxicity, is being combined with pomalidomide, bortezomib, and dexamethasone to combat multiple myeloma. The quadruple combination study aims to increase the success rate of treatment by utilizing different mechanisms of action.
Sylentis has begun a Phase III clinical trial to evaluate the efficacy of SYL1001 in treating dry eye syndrome. The study aims to improve signs and symptoms of the condition, including chronic loss of lubrication and hydration on the ocular surface.
PharmaMar has reported new data on the mechanism of action of plitidepsin and lurbinectedin, two compounds being investigated for their potential to treat multiple myeloma and ovarian cancer. The study demonstrates the capacity of lurbinectedin to reverse cisplatin resistance in ovarian cancer cells.
ADC MI130110 shows remarkable antitumoral activity in CD13-expressing tumor cells, impairing tubulin polymerization and disrupting the microtubule network. The treatment resulted in significant reduction in tumor size, complete remission, and increased median survival time.
PharmaMar is conducting a Phase I study to determine the recommended dose of PM1183 in Japanese patients, with secondary objectives including safety profile and antitumor activity evaluation. The study focuses on patients born in Japan or with Japanese ancestry affected by solid tumors.
PharmaMar announces completion of Phase 3 pivotal study CORAIL with lurbinectedin (PM1183) for platinum-resistant ovarian cancer. The study demonstrates potential therapeutic alternative for patients who relapse after standard treatment. PharmaMar has successfully recruited 443 patients from over 100 hospitals in Europe and the USA.
PharmaMar's Phase 2 study shows significant reduction in tumor size and improved survival rates for patients with BRCA 1/2 metastatic breast cancer. The trial achieved an overall response rate of 41% with a 61% response rate in the BRCA 2 subgroup.
PharmaMar presents updated clinical trial data for its antitumoral compounds Yondelis and lurbinectedin, demonstrating efficacy in treating solid tumors such as breast, soft tissue sarcomas, and colorectal cancer. These findings support the potential of these molecules as treatments for various types of solid tumors.
The Independent Data Monitoring Committee approved PharmaMar's CORAIL study of PM1183 in patients with platinum-resistant ovarian cancer. The pivotal Phase III trial evaluates the efficacy of PM1183 compared to standard treatments.
PharmaMar starts a pivotal Phase III ATLANTIS study evaluating efficacy and safety of PM1183 in combination with doxorubicin versus topotecan or VCR for patients with SCLC after prior platinum-containing line failure. The primary endpoint is to improve progression-free survival.
PharmaMar announces the start of a multicenter study evaluating plitidepsin's efficacy in patients with relapsed and refractory angioimmunoblastic T-cell lymphoma. The primary endpoint is overall response rate, while secondary endpoints include duration of response, progression-free survival, and pharmacokinetic characteristics.
A Phase I study of plitidepsin in combination with bortezomib and dexamethasone demonstrated a 56% overall response rate, including very good partial responses. The treatment was well-tolerated, with no dose-limiting toxicities, and showed clinical benefit in 72% of patients.
PharmaMar showcases new compounds with unique mechanisms of action against solid and hematological tumors. Lurbinectedin attacks the microenvironment, Plitidepsin targets eEF1A2 protein, and PM184 disrupts blood vessels, cutting off nutrient and oxygen supply to tumor cells.
PharmaMar's Aplidin (plitidepsin) demonstrates a statistically significant reduction in multiple myeloma progression or death, meeting primary endpoint. The study enrolled 255 patients across 19 countries and showed promising results.
Sylentis presents positive Phase II results with SYL1001 for treating ocular discomfort, achieving primary and secondary endpoints in reducing ocular pain and conjunctival hyperaemia. The trials also confirm a favorable safety profile of SYL1001.
PharmaMar has initiated a Phase II clinical trial for its antitumor drug PM184, targeting hormone-receptor positive and HER2-negative breast cancer patients. The trial aims to evaluate the efficacy of PM184 on four-month progression-free survival and assess safety and pharmacological profiles.
The Independent Data Monitoring Committee has recommended continuing the Phase III trial with PM1183 due to positive safety data from the first 80 patients. The trial assesses PM1183's efficacy compared to standard treatments for platinum-resistant ovarian cancer.
PharmaMar's novel Antibody-Drug Conjugate (ADC) MI130004 demonstrates potent anticancer activity against HER2-expressing breast, gastric, and ovarian cancers. The ADC impairs tubulin polymerization, causing mitotic failures and halting cell division in tumor cells.
PharmaMar presents new studies on the treatment of ovarian cancer using YONDELIS (trabectedin) and PM1183, showing promising results in managing recurrent cancer. The studies highlight the potential benefits of combining these therapies to improve patient outcomes.
Bamosiran reduced IOP by similar magnitude across four doses, but failed to demonstrate non-inferiority to timolol in total population; showed excellent tolerability and non-inferiority at dose 1.125% in patients with baseline IOP >=25mmHg
A large prospective post-commercialization study in patients with advanced soft tissue sarcoma (STS) in Europe confirms the long-term anticancer activity of YONDELIS® (trabectedin). The median progression-free survival was 5.5 months, and durable responses were observed in 18 patients still on treatment.
The EORTC 1320 trial, coordinated by the EORTC Brain Tumor Group, aims to assess the efficacy and safety of YONDELIS (trabectedin) compared to standard care in patients with recurrent grade II or III meningioma. The study plans to accrue 86 patients across 47 sites in ten countries.
PharmaMar has initiated a multicenter, international phase II Basket trial to evaluate the efficacy and safety of PM1183 (lurbinectedin) in patients with various advanced solid tumors. The trial will assess the overall response rate, duration of response, and pharmacokinetic properties of the drug.
PharmaMar presents new data for YONDELIS (trabectedin) in soft tissue sarcoma and solid tumors, including final overall survival analysis and real-world data from a large prospective phase IV study. Additionally, early clinical studies show synergistic activity for PM1183 in combination with paclitaxel or cisplatin.
Dr. Maurizio D'Incalci receives the first Pezcoller-Prodi Award in recognition of his work on translational cancer research and therapeutic oncology. The award highlights his contributions to the development of novel anticancer drugs, including trabectedin.
In the ATREUS trial, 41.2% of patients treated with trabectedin in second line showed improved survival and median progression-free survival at 12 weeks. The study adds to scarce evidence-based science in this disease, warranting further investigation.
The combination treatment induced objective responses in 67% of patients with small cell lung cancer, including 10% complete responses. Durable responses were observed, with an overall progression-free survival of 4.6 months.
PharmaMar presents clinical studies showcasing the efficacy of YONDELIS and PM1183 in treating small cell lung cancer, soft tissue sarcoma, and malignant pleural mesothelioma. The studies demonstrate promising results with a response rate of 67% for PM1183 in SCLC.
PharmaMar is presenting data on its anticancer candidates PM1183 and plitidepsin, showing synergistic effects against breast cancer cell lines and SCLC mouse tumor models. The company's studies also highlight the potential of plitidepsin as a novel therapeutic target in multiple myeloma.
A large retrospective study of 885 patients with soft-tissue sarcoma found that YONDELIS treatment was effective, with median progression-free survival and overall survival of 4.4 and 12.2 months, respectively. Early administration as second-line therapy may optimize efficacy.
A study in Lancet Oncology suggests continued treatment with YONDELIS for advanced soft-tissue sarcoma patients who have not progressed after six courses improves progression-free survival. The results also indicate that a drug holiday may worsen outcomes.
PharmaMar presents results highlighting a pipeline of targeted therapies, including Aplidin, an antitumoral compound targeting eEF1A2, and an ADC combining a marine-derived agent with trastuzumab. The company's pipeline includes multiple compounds in clinical development for various tumor types.