|BioMed News Bytes: BSD Medical, Provectus, Incyte, OncoMethylome|
|Tuesday, 22 September 2009 08:33|
On 9/21/09, Provectus Pharma (OTC: PVCT.OB) ($0.96, +1%, above-average volume on 21-Sep) announced that it completed the treatment portion, including all protocol-allowed retreatments of all patients, of its Phase 2 clinical trial of PV-10 for metastatic melanoma.
The study involved treatment of 80 subjects with Stage III or Stage IV metastatic melanoma. The primary objective of the Phase 2 study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. The study also includes assessment of response in untreated bystander lesions following intralesional injection of PV-10 into treated lesions.
Additional objectives of the trial are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection. The Phase 2 study is an interventional, open-label, multicenter, single group assignment safety/efficacy study. To accurately reflect anticipated clinical use, repeat dosing of lesions not exhibiting complete response was allowed at the investigator’s discretion several times following initial treatment. Subjects are followed for 52 weeks following initial treatment with PV-10. The estimated primary completion date for this trial is May 2010, with an estimated study completion date of July 2010.
On 9/21/09, Incyte Corp. (NASDAQ: INCY) ($7.97, +9%, above-average volume on 21-Sep) announced positive clinical trial results for a topical formulation of its lead janus kinase (JAK) inhibitor, INCB18424, in psoriasis. These results were obtained from a multi-center three-month Phase IIb trial comparing three once-daily doses of topical INCB18424 to vehicle in 200 patients with mild-to-moderate psoriasis. In the trial patients treated with INCB18424 had a statistically significant improvement over placebo in the reduction in total lesion score (erythema + scaling + thickness), which was the primary efficacy endpoint of the trial.
Statistical significance was also achieved for the secondary endpoints: the Physician Global Assessment score and the Psoriasis Area and Severity Index score. INCB18424 was well tolerated at all doses and no clinically significant effects were noted in hematology or other laboratory parameters. Incyte intends to present full results from this Phase IIb trial at an appropriate future scientific meeting.
On 9/21/09, results were presented in Europe by OncoMethylome Sciences (EBR: ONCOB.BR) ($6.60, +10%, above-average volume on 21-Sep) for a blood-based diagnostic test for colorectal cancer (CRC). The researchers collected blood before surgery from 193 patients known to have CRC, as well as from 688 controls undergoing colonoscopy for cancer screening. DNA was extracted from the blood plasma and tested for the presence of DNA methylation of specific genes. Based on studies conducted in colorectal tissues, methylated genes that were capable of discriminating accurately between cancerous and normal tissues were chosen, including two newly reported methylation genes, SYNE1 and FOXE1, in patients with CRC that occur infrequently in individuals who do not have the disease.
When testing a first set of 444 controls and 124 colorectal cancer patients, with plasma volumes ranging between 0.8—4.3 mL (as a reference point, 1 teaspoon = 5 mL), the sensitivity and specificity for the combination of SYNE1 and FOXE1 was 58% and 90% respectively. Testing this marker combination in a second, independent group of 242 controls and 69 cases, the sensitivity (proportion of positives correctly identified) and specificity (proportion of negatives correctly identified) were 56% and 91% respectively (77% and 91% in the samples with at least 3.3 ml of plasma).
The sensitivity for stage I and II CRC was 41% and 80%, respectively. The scientists are currently enrolling people into a prospective colorectal screening study in several German colonoscopy facilities and expect to complete enrollment of 7,000 people by the end of 2009 in conjunction with discussions to several partners about distribution rights.
The V3 stool DNA screening technology being developed by EXACT Sciences (NASDAQ:EXAS) outperforms blood-based tests, especially for earlier stage disease / pre-cancer detection, which is critical for improved treatment and survival outcomes. In August 2008, research was published in which a total of 25 sDNA samples from CRC patients were analyzed and a next generation stool DNA technology (V3) correctly identified 23 (92%) of the cancers. In the 16 of 25 cases where there were paired stool and plasma DNA samples, the sDNA technology detected mutated DNA in stool in 14 cases (88%) while only 8 (50%) corresponding plasma DNA samples had detectable levels of mutated DNA.
In addition, improvements to stool DNA screening technology to-date include ability to detect over 85% of CRCs and 50% of pre-cancers (higher than the 41% sensitivity for Phase I CRC reported yesterday by OncoMethylome) versus rates of about 50% and 20%, respectively, with potential to expand sDNA screening technology for other GI-related cancers such as gastric, pancreatic, etc. after commercializing the V3 test for CRC.
Another key development for EXAS discussed at the Rodman Healthcare conference is the replacement of a large collection bucket associated with the Company’s stool DNA screening test for CRC with a much smaller (less than two ounces) system that will greatly enhance the commercial prospects and logistics associated with the development of the next-generation V3 test. The much smaller size of the collection system for the V3 test will make it much easier for doctors to store in their offices and simplify the shipping process for lab processing.
This adds to positive news announced during the 2Q09 conference that the Company’s pending Phase 3 FDA study is likely to be much smaller in scale (e.g. 3,000 subjects) and less costly versus the previous guidance of 8,000-10,000 subjects enrolled at 30-40 clinical sites that would have taken 12-18 months to complete. The objective of this study is to obtain broad claims and FDA marketing clearance for a non-invasive stool DNA based CRC screening test, including the detection of pre-cancers. The stock research section of BioMedReports.com includes my 2Q09 update report for EXAS, including an earnings model in the U.S. market, targeting a major unmet medical need for an estimated 90 million people over the age of 50.
On 9/22/09, BSD Medical (NASDAQ: BSDM) ($3.85, +105%, above-average volume on 22-Sep) announced that clinical trial results were the subject of a news briefing at Europe’s largest cancer congress (ECCO15 – ESMO34) which utilized the BSD-2000 Hyperthermia System, demonstrating that patients with high risk soft-tissue sarcomas were 30% more likely to be alive and cancer free almost three years after starting treatment if targeted heat therapy (hyperthermia) was added to their chemotherapy treatment.
The Phase 3 study involved 341 patients who were treated at medical centers in Europe and in the U.S. All patients had locally advanced soft tissue sarcomas and were at high risk of recurrence and spread. All patients were given chemotherapy before and after surgery and radiotherapy. Half of the patients were randomly given hyperthermia along with chemotherapy.
“The patients receiving the targeted heat therapy fared better on all outcome measurements,” Prof. Issels said. “Almost three years after starting treatment, they were 42% less likely to experience a recurrence of their cancer at the same site or to die than those who were getting chemotherapy alone, surviving an estimated 120 months before local progression of their disease, compared with an estimated 75 months. Similarly, the average length of time that patients remained disease free was 32 months in the group that got both treatments, compared with 18 months in the group that got chemotherapy alone – an improvement of 30%.”
On 5/18/09, BSDM announced that the FDA has granted Humanitarian Use Device (HUD) designation for the company’s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device’s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the U.S. per year.
Now that FDA has granted the HUD for the BSD-2000, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. BSDM believes that data previously submitted to FDA and reviewed by the Agency as part of the Company’s pending medical device Pre-market Approval (PMA) submission can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.
Due to the lengthy nature of the PMA review process, the length of time that the submission has been under review by the FDA, and the Company’s strong desire to bring the BSD-2000 to market as quickly as possible, the FDA recommended that BSDM pursue a HDE marketing approval to authorize the commercial sale of the BSD-2000 in the U.S. On 1/7/08, BSDM received a letter from the FDA providing guidance as to amendments needed to make the PMA approvable and the Company responded to this letter on 7/17/08.
In a letter to shareholders on 7/29/09, BSDM stated that, “We expect to hear from the FDA very soon regarding our HDE application.”
Disclosure: Long EXAS.
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