Genentech Provides Update on Phase III Verona Study
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and AbbVie announced today the outcome from the Phase III VERONA study (NCT04401748) investigating Venclexta ® (venetoclax) plus azacitidine for patients with previously untreated higher-risk myelodysplastic syndromes (MDS). The study did not meet the primary endpoint of overall survival at the final analysis. The safety profile of the Venclexta combination was consistent with the known risk of the individual study medicines and no unexpected safety signals were observed. Full data will be presented at an upcoming medical meeting in 2025.
VERONA is a global, AbbVie-led, Phase III, multicenter, randomized, double-blind study evaluating Venclexta in combination with azacitidine compared to placebo plus azacitidine in treatment-naïve patients with higher-risk MDS. The study includes approximately 500 patients across 220 sites globally who were randomly assigned to either Venclexta plus azacitidine or placebo plus azacitidine. Patients who received Venclexta in combination with azacitidine through participation in the MDS clinical trials will be informed by their treating physician.
The results of the VERONA study have no impact on the approved indications for Venclexta or any ongoing studies.
About Venclexta ® (venetoclax)
Venclexta is a first-in-class targeted medicine designed to bind selectively and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood cancers.
Venclexta ® (venetoclax) U.S. Indication
Venclexta is a prescription medicine used:
to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:
are 75 years of age or older, or
have other medical conditions that prevent the use of standard chemotherapy.
It is not known if Venclexta is safe and effective in children.
Important Safety Information
What is the most important information patients should know about Venclexta?
Venclexta can cause serious side effects, including:
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. The patient's doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS.
The patient may also need to receive intravenous (IV) fluids into their vein. The patient's doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.
Patients should drink plenty of water during treatment with Venclexta to help reduce the risk of getting TLS.
Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before the first dose on the day of the first dose of Venclexta, and each time a dose is increased.
The patient's doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects. When restarting Venclexta after stopping for 1 week or longer, the patient's doctor may again check for the risk of TLS and change the patient's dose.
What patients should not take Venclexta?
Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased TLS.
Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other causing serious side effects.
Patients must not start new medicines during treatment with Venclexta without first talking with their doctor.
Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they:
Have kidney or liver problems.
Have problems with body salts or electrolytes, such as potassium, phosphorus, or calcium.
Have a history of high uric acid levels in the blood or gout.
Are scheduled to receive a vaccine. Patients should not receive a 'live vaccine' before, during, or after treatment with Venclexta, until the patient's doctor tells them it is okay. If the patient is not sure about the type of immunization or vaccine, the patient should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta.
Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If the patient is able to become pregnant, the patient's doctor should do a pregnancy test before the patient starts treatment with Venclexta, and the patient should use effective birth control during treatment and for at least 30 days after the last dose of Venclexta. If the patient becomes pregnant or thinks they are pregnant, the patient should tell their doctor right away.
Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into the patient's breast milk. Patients are instructed to not breastfeed during treatment with Venclexta and for 1 week after the last dose.
What to avoid while taking Venclexta:
Patients should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient's blood.
What are the possible side effects of Venclexta?
Venclexta can cause serious side effects, including:
Low white blood cell counts (neutropenia). Low white blood cell counts are common with Venclexta, but can also be severe. The patient's doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing.
Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. The patient's doctor will closely monitor and treat the patient right away if they have a fever or any signs of infection during treatment with Venclexta.
Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta.
The most common side effects of Venclexta when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of arms, legs, hands, and feet.
The most common side effects of Venclexta in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.
Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility.
These are not all the possible side effects of Venclexta. Patients should call their doctor for medical advice about side effects.
You may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see the Venclexta full Prescribing Information, including the Medication Guide, for additional Important Safety Information.
About Genentech in Hematology
For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we're investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http:// www.gene.com.
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For further information, please refer to the Company's website at or the Company's profile on SEDAR+ at _________________________ 2 "lAMGOLD Announces Significant Increase in Nelligan Ounces & Update of Global Mineral Reserves and Resources"; IAMGOLD reports increase in mineral reserves and resources at existing assets, with increase in resources at Gosselin; IAMGOLD Corporation News Release dated February 15, 2024, October 23, 2024, and February 20, 2025. Note that the technical and scientific information disclosed from neighboring properties does not apply to any other properties of the area. 3 Independent Technical Report MINERAL RESOURCES ESTIMATION OF THE PHILIBERT PROJECT Québec, Canada. September 22, 2023. Prepared in accordance with NI 43-101 by Goldminds Geoservice Inc. to Northern Superior Resources. Philibert hosts a maiden 43-101 inferred resource of 48.5 Mt at 1.10 g/t Au for 1,708,800 ounces Au and an indicated resource of 7.9 Mt tonnes at 1.10 g/t Au for 278,900 ounces Au Note that the technical and scientific information disclosed from neighboring properties does not apply to any other properties of the area. 4 NI 43-101 Technical Report Mineral Resource Estimation for the Chevrier Main Deposit, Chevrier Project Chibougamau, Quebec, Canada, October 20, 2021, Prepared in accordance with NI 43-101 by Lions Gate Geological Consulting Inc. IOS Services Géoscientifiques Inc. for Northern Superior. 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The information in this news release about the proposed transaction, the use of proceeds of the Offering, required approvals, and any other information herein that is not a historical fact may be "forward-looking information". Any statement that involves discussions with respect to predictions, expectations, interpretations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "interpreted", "management's view", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward- looking information and are intended to identify forward-looking information. This forward-looking information is based on reasonable assumptions and estimates of management of Northern Superior, at the time it was made, involves known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the companies to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Such factors include, among others, risks relating to the ability of the parties to execute the proposed transaction, risks related to regulatory approvals of the Offering and the use of proceeds thereof. Although the forward-looking information contained in this news release is based upon what management believes, or believed at the time, to be reasonable assumptions, the parties cannot assure shareholders and prospective purchasers of securities that actual results will be consistent with such forward-looking information, as there may be other factors that cause results not to be as anticipated, estimated or intended, and neither party nor any other person assumes responsibility for the accuracy and completeness of any such forward-looking information. Neither party undertakes, and assumes no obligation, to update or revise any such forward-looking statements or forward-looking information contained herein to reflect new events or circumstances, except as may be required by law. SOURCE Northern Superior Resources Inc. 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VitalHub Files Preliminary Base Shelf Prospectus
TORONTO, June 16, 2025 (GLOBE NEWSWIRE) -- Vitalhub Corp. (TSX: VHI) (OTCQX: VHIBF) (the 'Company' or 'VitalHub') announces that today it has filed and obtained a receipt for a preliminary short form base shelf prospectus with the securities regulatory authorities in the provinces of Alberta, British Columbia, and Ontario. The base shelf prospectus has not yet become final for the purpose of the sale of any securities. When made final and effective, the base shelf prospectus will allow the Company to qualify the distribution of up to $250 million of common shares, debt securities, warrants, subscription receipts, units, or any combination thereof, during the 25‐month period that the base shelf prospectus is effective. The specific terms of any offering under the base shelf prospectus will be established in a prospectus supplement, which will be filed with the applicable Canadian securities regulatory authorities in connection with any such offering. VitalHub does not have any immediate plans to offer securities under the shelf prospectus. No securities may be sold nor may offers to buy be accepted prior to the time at which a receipt for the final base shelf prospectus is obtained from applicable Canadian securities regulatory authorities. This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state, or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state, or jurisdiction. A copy of the preliminary short form base shelf prospectus can be found under VitalHub's profile on SEDAR+ at About VitalHub VitalHub is a leading software company dedicated to empowering health and human services providers globally. VitalHub's comprehensive product suite includes electronic health records, operational intelligence, and workforce automation solutions that serve over 1,000 clients across the UK, Canada, and other geographies. The Company has a robust two-pronged growth strategy, targeting organic opportunities within its product suite and pursuing an aggressive M&A plan. VitalHub is headquartered in Toronto with over 500 employees globally, across key regions and the VitalHub Innovations Lab in Sri Lanka. For more information about VitalHub (TSX: VHI) (OTCQX: VHIBF), please visit and connect with us on LinkedIn. Contact Information Christian Sgro, CPA, CA, CFAHead of IR and M&A Specialist(365) Dan MatlowChief Executive Officer, Director(416) Cautionary Statement Certain statements contained in this news release including filing of a final base shelf prospectus, future offerings, and filing of shelf prospectus supplements, may constitute "forward-looking information" or "financial outlook" within the meaning of applicable securities laws that involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information or financial outlook. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of each entity and are based on assumptions and subject to risks and uncertainties. Although the management of each entity believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed, including that there can be no guarantee that any offering under any prospectus supplement will be completed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
